[Federal Register Volume 61, Number 225 (Wednesday, November 20, 1996)]
[Rules and Regulations]
[Pages 59004-59022]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-29695]


-----------------------------------------------------------------------


DEPARTMENT OF HEALTH AND HUMAN SERVICES
21 CFR Part 810

[Docket No. 93N-0260]


Medical Device Recall Authority

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is establishing 
procedures for implementing the medical device recall authority 
provided in the Safe Medical Devices Act of 1990 (the SMDA). This 
statutory authority protects the public health by permitting FDA to 
remove dangerous devices from the market promptly. This authority 
complements other provisions of the device law, including tracking and 
notification.

DATES: The regulation is effective May 19, 1997.

    Written comments on the information collection requirements should 
be submitted by January 21, 1997.

ADDRESSES: Submit written comments on the collection of information 
requirements to the Dockets Management Branch (HFA-305), Food and Drug 
Administration, 12420 Parklawn Dr., rm. 1-23, Rockville, MD 20857.

FOR FURTHER INFORMATION CONTACT: John H. Samalik, Center for Devices 
and Radiological Health (HFZ-323), Food and Drug Administration, 2094 
Gaither Rd., Rockville, MD 20850, 301-594-4703.

SUPPLEMENTARY INFORMATION:

I. Background

    In the Federal Register of June 14, 1994 (59 FR 30656), FDA 
published a proposed rule to establish the procedures it will follow in 
exercising its medical device recall authority provided in the SMDA. 
Interested persons were given until September 12, 1994, to comment on 
the proposed regulation. FDA received a total of nine comments from an 
infant ventilator manufacturer, a regulatory consulting corporation, an 
electrical manufacturers association, a medical device manufacturers 
association, a manufacturer of in vitro diagnostic products, and four 
other medical device companies.

II. Summary of the Final Rule

    Section 8 of the SMDA (Pub. L. 101-629) amends section 518 of the 
Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 360h) by 
adding a new subsection (e) entitled ``Recall Authority.'' Section 
518(e)(1) of the act provides that, if FDA finds that there is a 
reasonable probability that a device intended for human use would cause 
serious, adverse health consequences or death, FDA shall issue an order 
requiring the appropriate person to immediately cease distribution of 
the device, immediately notify health professionals and device user 
facilities of the order, and instruct such professionals and facilities 
to cease use of the device. Section 518(e)(2) of the act states that, 
after providing an opportunity for an informal hearing, FDA may amend 
the cease distribution and notification order to require a recall of 
the device.
    Section 502(t) of the act (21 U.S.C. 352(t)) provides that a device 
is misbranded if there is a failure or refusal to comply with any 
requirement prescribed under section 518 of the act respecting the 
device. Section 301(q)(1) of the act (21 U.S.C. 331(q)(1)) makes the 
failure or refusal to comply with any requirement prescribed under 
section 518 of the act, or the causing thereof, a prohibited act. A 
person subject to a cease distribution and notification order or a 
mandatory recall order issued

[[Page 59005]]

under section 518(e) of the act under these regulations, and who fails 
or refuses to comply, may therefore be subject to regulatory actions by 
FDA.
    Prior to issuing a cease distribution and notification order, FDA 
will conduct a Health Hazard Evaluation which will take into account 
the following factors: (1) Whether any disease or injuries have already 
occurred from the use of the product; (2) whether any existing 
conditions could contribute to a clinical situation that could expose 
humans or animals to a health hazard; (3) the hazard to various 
segments of the population who are expected to be exposed to the 
product being considered; (4) the degree of seriousness of the health 
hazard to which the populations at risk would be exposed; (5) the 
likelihood of occurrence of the hazard; (6) the consequences of 
occurrence of the hazard; as well as (7) the risk of ceasing 
distribution of the device as compared with the risk of not ceasing 
distribution of the device by considering, for example, the 
availability of alternate medical devices.
    Under new Sec. 810.11(a), the person named in a cease distribution 
and notification order may submit a written request to FDA for a 
regulatory hearing within the timeframe specified in the order, which, 
generally, will not be less than 3 working days after receipt of the 
order. (Throughout the preamble and the regulation the term 
``regulatory hearing'' references the ``informal hearing'' under 
section 518(e) of the act.) According to Sec. 810.11(b), if a request 
for a regulatory hearing is granted, the regulatory hearing is limited 
to reviewing the actions which prompted issuance of the cease 
distribution and notification order and determining if FDA should 
affirm, modify, or vacate the order or amend the cease distribution and 
notification order to require a recall of the device that was the 
subject of the order. The hearing may also address the actions that 
might be required by a recall order, including an appropriate recall 
strategy, if FDA later orders a recall.
    Under Sec. 810.11(c), if a request for a regulatory hearing is 
granted, the regulatory hearing will be conducted in accordance with 
the procedures set out in section 201(x) of the act (21 U.S.C. 321(x)) 
and part 16 (21 CFR part 16). After a regulatory hearing commences, the 
presiding officer may issue a summary decision on any issue if he or 
she determines that there is no genuine and substantial issue of fact 
respecting that issue. Under Sec. 810.11(e), the presiding officer will 
ordinarily hold any regulatory hearing under Sec. 810.11(a) no fewer 
than 2 working days after receipt of the request for a hearing and no 
later than 10 working days after the date of issuance of the cease 
distribution and notification order. However, FDA and the person named 
in the order may agree to a later date or the presiding officer may 
determine that the hearing should be held in fewer than 2 days. The 
presiding officer shall provide the requestor written notification of 
the agency's decision to affirm, modify, or vacate the order or amend 
the cease distribution and notification order to require a recall of 
the device within 15 working days after conducting a regulatory 
hearing.
    Under Sec. 810.12(a), in lieu of requesting a regulatory hearing 
under Sec. 810.11, the person named in the cease distribution and 
notification order may submit a written request to FDA asking that the 
order be modified or vacated. Such request must be submitted within the 
timeframe specified in the cease distribution and notification order, 
unless FDA and the person named in the order agree to a later date. In 
most cases, FDA will specify that a written request for review of a 
cease distribution and notification order must be submitted to the 
agency within 10 working days of issuance of the cease distribution and 
notification order, but generally not less than 3 working days after 
receipt of the order. According to Sec. 810.12(c), the agency official 
who issued the cease distribution and notification order shall provide 
the requestor written notification of the decision of the agency to 
affirm, modify, or vacate the order or amend the cease distribution and 
notification order to require a recall of the device within 15 working 
days of receipt of the written request.
    According to Sec. 810.13(a), if the person named in a cease 
distribution and notification order does not request a regulatory 
hearing or submit a request for agency review of the order, or, if 
after conducting a regulatory hearing or completing agency review of a 
cease distribution and notification order under Sec. 810.11 or 
Sec. 810.12, FDA determines that the order should be amended to require 
a recall of the device with respect to which the order was issued, FDA 
shall amend the order to require such a recall. FDA shall amend the 
order to require such a recall within 15 working days of issuance of a 
cease distribution and notification order if a regulatory hearing or 
agency review of the order is not requested or within 15 working days 
of conducting a regulatory hearing under Sec. 810.11 or completing 
agency review of a cease distribution and notification order under 
Sec. 810.12.
    According to Sec. 810.14(a), the person named in a cease 
distribution and notification order shall comply with the order, which 
FDA will fashion as appropriate for the individual circumstances of the 
case. The person named in a cease distribution and notification order 
modified under Sec. 810.11(e) or Sec. 810.12(c) or a mandatory recall 
order issued under Sec. 810.13 shall develop a strategy for complying 
with the order that is appropriate for the individual circumstances. 
Under Sec. 810.14(b)(1), the person named in the cease distribution and 
notification order modified under Sec. 810.11(e) or Sec. 810.12(c) or a 
mandatory recall order shall submit a copy of the proposed strategy to 
the agency within the timeframe specified in the order. Under 
Sec. 810.14(b)(2), the agency will review the proposed strategy and 
make any changes to the strategy that it deems necessary within 7 
working days of receipt of the proposed strategy. The person named in 
the cease distribution and notification order or mandatory recall order 
shall act in accordance with a strategy determined by FDA to be 
appropriate.
    Under Sec. 810.15(a), the person named in a cease distribution and 
notification order or a mandatory recall order is responsible for 
promptly notifying each health professional, user facility, consignee, 
or individual, as appropriate, of the order.
    Under Sec. 810.16(a), the person named in a cease distribution and 
notification order or a mandatory recall order shall submit periodic 
status reports to FDA to enable the agency to assess the person's 
progress in complying with the order.
    Under Sec. 810.17, the person named in a cease distribution and 
notification order or a mandatory recall order may request termination 
of the order by submitting a written request to FDA. FDA may terminate 
a cease distribution and notification order or a mandatory recall order 
when the agency determines that the person named in the order has taken 
all reasonable steps to ensure that all health professionals, device 
user facilities, consignees, and, where appropriate, individuals have 
been notified of the cease distribution and notification order and have 
complied with the instructions to cease use of the device; and that the 
person named in the order has removed the device from the market or has 
corrected the device so that use of the device would not cause serious, 
adverse health consequences or death. FDA will respond to a written 
request for termination of a cease distribution and

[[Page 59006]]

notification or recall order within 30 working days of its receipt.
    Under Sec. 810.18, the agency will make available to the public in 
the weekly FDA Enforcement Report a descriptive listing of each new 
mandatory recall issued under Sec. 810.13.

III. Relationship Between Temporary Suspension of Approval of a 
Premarket Approval Application (PMA) or PMA Supplement and Medical 
Device Recall Authority

    The SMDA provided FDA with, among other things, the authority to 
issue orders to temporarily suspend the approval of a PMA or a PMA 
supplement and to recall medical devices.
    Section 9 of the SMDA amends section 515(e) of the act (21 U.S.C. 
360e(e)) by adding section 515(e)(3) of the act which provides the 
agency with the authority to temporarily suspend approval of a PMA. 
This authority applies to the original PMA, as well as to any PMA 
supplement(s), for a medical device. Section 515(e)(3) of the act and 
21 CFR 814.47, the implementing regulation, provide the agency with a 
quick method of removing dangerous devices from the market pending 
resolution of permanent PMA or PMA supplement withdrawal proceedings.
    The agency's authority to temporarily suspend approval of a PMA 
and/or its PMA supplements may be invoked when FDA wants a manufacturer 
to remove from the market the class III device that was approved under 
the subject PMA or PMA supplement, pending permanent withdrawal of 
approval of the PMA and/or PMA supplements. On the other hand, FDA's 
medical device recall authority may be invoked, for example, when FDA 
wants an individual to cease distribution and/or recall certain lots, 
batches, models, or complete product lines of class I, class II, or 
class III devices that have been introduced into commerce until such 
devices are brought into compliance.
    The threshold criteria are identical for invoking the medical 
device recall authority and the authority to temporarily suspend 
approval of a PMA or PMA supplement. FDA may issue an order under 
either one of these authorities only when FDA has invoked that 
authority and has determined under that authority that there is a 
reasonable probability that continued distribution of a device would 
cause serious, adverse health consequences or death. Furthermore, under 
both authorities, FDA must provide the person subject to the order and 
the holder of the approved PMA or PMA supplement for the device with an 
opportunity for a regulatory hearing. In both situations, if a request 
for a regulatory hearing is granted, the regulatory hearing is to be 
conducted by FDA under part 16.
    The agency may invoke either its medical device recall authority or 
its authority to temporarily suspend approval of the PMA and/or PMA 
supplements for a class III device or both at once. If both authorities 
are invoked, and if regulatory hearings are requested and granted with 
respect to each one, the medical device recall regulatory hearing will 
be combined with the temporary suspension of approval of a PMA and/or 
PMA supplements regulatory hearing. This combined regulatory hearing 
will occur after FDA makes the requisite finding, issues a cease 
distribution and notification order, and issues a letter of intent to 
temporarily suspend approval of a PMA and/or PMA supplements. This 
combined regulatory hearing will not eliminate the PMA and/or PMA 
supplements holder's opportunity for a regulatory hearing prior to 
permanently withdrawing approval of a PMA and/or PMA supplements. (See 
section 515(e)(1) of the act.)

IV. Summary and Analysis of Comments and FDA's Responses

A. General Comments

    1. Various comments noted the absence of formal deadlines for the 
following: Issuance of a cease distribution and notification order 
(proposed Sec. 810.10(a)); completion of a regulatory hearing (proposed 
Sec. 810.11(e)); receipt of a written request for review of a cease 
distribution and notification order (proposed Sec. 810.12(c)); issuance 
of a mandatory recall order (proposed Sec. 810.13(a)); amending a cease 
distribution and notification order to include a mandatory recall order 
after an initial determination that a recall is not necessary (proposed 
Sec. 810.13(e) deleted in the final regulation); review and acceptance 
of a cease distribution and notification of mandatory recall strategy 
prior to initiating the strategy (proposed Sec. 810.14(a)(7), 
renumbered as Sec. 810.14(b)(2) in the final regulation); and receipt 
of a request for termination of a cease distribution and notification 
order or a recall order (proposed Sec. 810.17(c)).
    The comments requested deadlines for these actions. Moreover, the 
comments requested that FDA automatically vacate cease distribution and 
notification orders, mandatory recall orders, and/or strategies in the 
absence of FDA action within a fixed number of days. According to these 
comments, the absence of deadlines creates the possibility that such 
orders will become a preliminary or permanent injunction in those 
situations where FDA is slow in completing its deliberations.
    Two other comments stated that the absence of such deadlines is 
inconsistent with the congressional intent that ``the hearing be 
analogous to a hearing on a temporary restraining order'' (TRO). 
According to these comments, hearings commenced under a TRO occur prior 
to the issuance of a TRO, and TRO's remain in effect for a limited time 
period not to exceed 10 days while the court decides whether or not to 
issue a preliminary injunction.
    FDA agrees that timeframes for certain agency actions in the recall 
context would be useful.
    FDA will be given 15 working days to complete its deliberative 
process following the completion of a regulatory hearing 
(Sec. 810.11(e)) or receipt of a written request for review of a cease 
distribution and notification order (Sec. 810.12(c)). Accordingly, 
under Sec. 810.13(a), FDA will amend a cease distribution and 
notification order to include a mandatory recall within 15 working days 
of issuance of the cease distribution and notification order if a 
regulatory hearing or agency review of the order is not requested, 
within 15 working days of denying a request for a hearing, or within 15 
working days after conducting a regulatory hearing under Sec. 810.11 or 
receiving a written request for review of a cease distribution and 
notification order under Sec. 810.12.
    FDA has omitted proposed Sec. 810.13(e) from the final rule. 
Therefore, there is no need to consider establishment of a deadline for 
this section.
    Under Sec. 810.14(b)(2), the agency will review and amend, reject, 
or accept a proposed strategy for a cease distribution and notification 
order modified under Sec. 810.11(e) or Sec. 810.12(c) or a mandatory 
recall within 7 working days of receipt of such a strategy.
    As suggested by the legislative history, under Sec. 810.17(c), FDA 
will respond to a written request for termination of a cease 
distribution and notification or recall order within 30 working days of 
its receipt. (See S. Rept. 513, 101st Cong., 2d. sess. 37 (1990).)
    FDA believes it is unnecessary to establish a deadline under 
Sec. 810.10(a) because until FDA issues a cease distribution and 
notification order the firm may continue to distribute medical devices. 
Therefore, under this section, FDA's failure to act within a specified

[[Page 59007]]

timeframe would not affect a company's ability to distribute products.
    In the interest of public health, FDA disagrees that it should 
automatically vacate cease distribution and notification orders, 
mandatory recall orders, and/or strategies if FDA fails to act within 
the number of days specified for the various actions above. Moreover, 
the agency disagrees with the comments that stated that formal 
deadlines are needed because Congress analogized the regulatory hearing 
to a judicial hearing on a TRO. The point of Congress' analogy to TRO's 
is that the agency should be able, when needed, to provide notice, hold 
the regulatory hearing, and issue its decision in a single day. (See H. 
Rept. 808, 101st Cong., 2d sess. 29 (1990).) That is, Congress intended 
to permit the agency to act quickly, but it did not intend to require 
the agency to do so.
    2. A comment requested that the rule be modified to include 
examples and/or more specific standards or factors to be met before a 
cease distribution and notification or mandatory recall occurs, which 
would ensure consistency among such decisions.
    In drafting the SMDA, both the House of Representatives and the 
Senate focused on the implementation and enforcement of section 518 of 
the act since its enactment in the Medical Device Amendments of 1976 
(Pub. L. 94-295) (the amendments). (See 59 FR 30656, June 14, 1994.) 
Section 518 of the act authorizes FDA to require notification of a risk 
to health presented by a medical device, or to require repair, 
replacement, or refund of the purchase price of a device. The House of 
Representatives noted that under section 518(b) of the act:
    [E]ven when the FDA has discovered a serious health hazard 
associated with a medical device, the Agency faces a unique barrier 
to enforcing important administrative remedies. Unlike other health 
and safety agencies, FDA may not take administrative action to order 
a defective device recalled unless it can show that the device did 
not meet the state-of-the-art at the time it was designed and 
manufactured.
(H. Rept. 808, 101st Cong., 2d sess. 14 (1990))
Furthermore, the Senate found that ``[T]he `repair, replacement, or 
refund' provisions of section 518(b) of the Act have never been used. 
Section 518(b)'s intricate findings and procedures have served as an 
inappropriate deterrent to its use.'' (See S. Rept. 513, 101st Cong., 
2d sess. 19 (1990).) Based on these findings, Congress determined that 
a more simplified and strengthened recall authority was needed. Thus, 
Congress explicitly stated that, under the new recall authority, FDA 
``will have considerable discretion in determining whether it is more 
likely than not that the continued distribution of a device would cause 
serious, adverse health consequences or death.'' (See S. Rept. 513, 
101st Cong., 2d sess. 19 (1990).)
    As the agency explained in the proposed rule:
    The mandatory recall authority in section 518(e) of the act 
complements existing provisions in sections 518(a), (b), and (c) of 
the act. Section 518(e) provides that, if FDA finds that there is a 
reasonable probability that a device intended for human use would 
cause serious, adverse health consequences or death, FDA may order 
the appropriate person(s) to immediately cease distribution of the 
device, to immediately notify health professionals and device user 
facilities of the order, and to instruct such professionals and 
facilities to cease use of the device. Section 518(e) of the act 
also states that, after providing an opportunity for an informal 
hearing, FDA may amend the cease distribution and notification order 
to require a recall of the device. This new authority protects the 
public health by permitting FDA to ensure the prompt removal of 
dangerous and defective devices from the market.
59 FR 30656. Under this provision, therefore, the agency has the 
discretion both to invoke the provision and, once the provision is 
invoked and appropriate findings are made, to exercise discretion 
regarding issuance of any orders under this provision.
    While having necessary discretion under this provision, FDA also 
recognizes that it is important to exercise that discretion 
judiciously. Accordingly, under 21 CFR 5.56, the Directors and Deputy 
Directors of the Center for Devices and Radiological Health (CDRH), the 
Center for Drug Evaluation and Research (CDER), the Center for 
Biologics Evaluation and Research (CBER), and the Directors and Deputy 
Directors of the Offices of Compliance of CDRH, CDER, and CBER are the 
FDA officials within these centers authorized to invoke section 518(e) 
of the act for medical devices assigned to their respective 
organizations. Limiting decisionmaking authority to these FDA 
headquarters officials will help to ensure consistent determinations 
regarding whether to issue such orders.
    Moreover, for cease distribution and notification orders and recall 
orders, FDA interprets the standard in Secs. 810.10(a) and 810.13 to 
match very closely the elements of a class I voluntary recall under 
part 7, subpart C (21 CFR part 7, subpart C), for which the agency has 
a long record of experience. Because FDA expects that most device 
manufacturers will voluntarily initiate a recall, it also expects that 
most serious health hazards associated with use of devices warranting a 
recall will continue to be handled under the voluntary recall guideline 
found in part 7, subpart C.
    3. Several comments stated that the proposed rule fails to provide 
the individual named in the cease distribution and notification order 
with the following opportunities to be heard prior to issuance of the 
order: (a) To petition for a hearing prior to notification of customers 
of a cease distribution order; (b) to provide data and/or comments from 
their firm regarding the safety and effectiveness of the firm's device 
before a cease distribution and notification order is issued; (c) to 
provide for review by outside, experienced medical experts and/or 
clinicians who use the device; (d) to provide for open, informal 
communications between FDA and expert consultants prior to or in lieu 
of a cease distribution and notification order; (e) to discuss with FDA 
the basis for the cease distribution and notification order before 
taking action; or (f) to hold a hearing prior to the time when the 
individual subject to the order must take the specified actions, 
including notifying affected users.
    Another comment noted that FDA's requirement that device user 
facilities must still be notified if a hearing is requested defeats the 
intent of section 518(e) of the act. According to the comment, it is 
meaningless to hold a hearing on the actions required by the order or 
for the Secretary to vacate the order if the person subject to the 
order already has taken the specified actions, including notification 
of affected users.
    FDA agrees with the value of consulting with the device 
manufacturer prior to issuance of a cease distribution and notification 
order. Accordingly, FDA has amended Sec. 810.10(a) to provide that 
before FDA makes the requisite finding that there is a reasonable 
probability that a device would cause serious, adverse health 
consequences or death, FDA will informally notify the appropriate 
individual of its tentative findings and provide the appropriate 
individual with an opportunity to consult with the agency. Because it 
may be necessary for the agency to act quickly to protect the public 
health, the extent of this consultation may be limited. The agency 
nevertheless expects that, typically, during this informal notification 
stage the individual may provide FDA with data and/or comments 
regarding the safety and effectiveness of the device, may provide 
review by outside, experienced medical experts, may solicit 
communications from expert consultants, and/or may discuss the basis of 
the order with FDA. During this

[[Page 59008]]

stage, FDA will provide the appropriate individual with an opportunity 
to convince FDA that there is no basis for the agency to make the 
requisite finding, or, alternatively, for that appropriate individual 
to conclude that the device should be voluntarily recalled.
    If the appropriate person convinces FDA that there is no basis for 
making the finding that there is a reasonable probability that a device 
would cause serious, adverse health consequences or death or that the 
appropriate person has acted responsibly in conducting an adequate 
voluntary recall, FDA will not likely make such a finding. However, if 
the appropriate person fails to convince FDA that there is no basis for 
such a finding or fails to act responsibly in conducting an adequate 
voluntary recall, the agency will make the requisite finding. In either 
case, the individual is provided with an opportunity to challenge FDA's 
tentative findings before the agency adopts them.
    Moreover, under the legislative history of the medical device 
recall authority, individuals must immediately notify customers and 
cease distribution under an order, after which the opportunity for a 
hearing follows:
    The conference agreement requires the Secretary, after making an 
appropriate finding, to issue an initial order providing for the 
immediate cessation and use of the device, with an informal hearing 
to follow within 10 days to determine whether to vacate the order or 
whether to amend the order to require a recall.
(H. Conf. Rept. 959, 101st Cong., 2d sess. 25 (1990))
FDA has interpreted this statement to mean that if a hearing is 
requested, the device still may not be distributed and health 
professionals and device user facilities must still be notified. (See 
59 FR 30656 at 30657.)
    4. Several comments implied that the medical device recall 
regulation needs to clarify the criteria for issuing mandatory recall 
orders.
    A recall may occur only after FDA has done the following: (a) Made 
the requisite finding, (b) issued a cease distribution and notification 
order, (c) provided the person named in the cease distribution and 
notification order with an opportunity for a regulatory hearing, and 
(d) determined that a recall of a device from a device user facility 
will not present a greater health risk than the health risk of not 
recalling the device from use. Under the medical device recall 
regulation, FDA may amend a cease distribution and notification order 
to include a mandatory recall in three circumstances.
    Under the first circumstance, FDA may amend a cease distribution 
and notification order to include a recall if the individual named in 
the cease distribution and notification order complies with the order 
and requests a regulatory hearing, but is unable to demonstrate that 
all devices subject to the order do not pose a reasonable probability 
of causing serious, adverse health consequences or death. If the 
individual named in the order is able to demonstrate that devices do 
not pose a reasonable probability of causing serious, adverse health 
consequences or death, then FDA will allow those devices to be 
distributed and used. Simultaneously, in accordance with section 
518(e)(1) of the act, FDA will vacate the cease distribution and 
notification order for these devices because inadequate grounds exist 
to support the actions required by the cease distribution and 
notification order.
    Under the second circumstance, FDA may amend a cease distribution 
and notification order to include a recall order if the individual 
named in the order does not comply with the order and does not request 
a regulatory hearing. FDA will issue a recall order to retrieve the 
devices that were shipped to wholesalers, retailers, or users contrary 
to the cease distribution and notification order when these devices 
continue to pose a reasonable probability of causing serious, adverse 
health consequences or death.
    Under the third circumstance, FDA may amend a cease distribution 
and notification order to include a mandatory recall if the individual 
named in the order complies with the order and initiates a voluntary 
recall which is found to be ineffective, i.e., the devices subject to 
voluntary recall actions continue to pose a reasonable probability of 
causing serious, adverse health consequences or death. In this 
situation, FDA may amend the order to include a mandatory recall 
because the devices continue to pose a reasonable probability of 
causing serious, adverse health consequences or death.
    In all the circumstances described above, FDA retains the authority 
to amend the cease distribution and notification order to include a 
recall order because the devices subject to the cease distribution and 
notification order continue to pose a reasonable probability of causing 
serious, adverse health consequences or death.
    5. A comment stated that some FDA personnel would use proposed 
Sec. 810.11(a) to establish unreasonable deadlines for requesting a 
regulatory hearing. The comment emphasized that FDA's regulations 
relating to regulatory hearings (Sec. 16.22(b)) specify that the 
manufacturer is to have a minimum of 3 working days to request a 
hearing. Thus, the comment recommended that the section be revised as 
follows: ``Any request for a regulatory hearing shall be submitted in 
writing to the agency employee identified in the order within the 
timeframe specified by FDA, which shall not be less than three working 
days.''
    According to two comments, proposed Sec. 810.11(e), which allows 
FDA to hold a regulatory hearing in less than 3 days from the date of 
notice of the order, provides inadequate notice and opportunity to 
prepare for an informal hearing, e.g., to prepare expert witnesses. 
Therefore, one of the comments suggested that special findings be 
required when FDA seeks to require a respondent to participate in a 
regulatory hearing in less than 10 days. Another comment suggested that 
the phrase ``no less than 5 days and no later than 10 days after 
receipt of the distribution and notification order'' be incorporated in 
this section. Another comment stated that proposed Sec. 810.11(e) needs 
to be more clearly defined as to implementation, threshold for its use, 
level of approval needed for this action, and parameters within which 
it can be used given FDA's broad authority to require an immediate 
hearing under this section.
    FDA agrees that Sec. 810.11(a) and (e) should be revised to 
reference the regulatory hearing procedures set out in part 16. Thus, 
the agency has changed Sec. 810.11(a) so that the person offered an 
opportunity for a hearing has the amount of time specified in the 
notice, which, in accordance with Sec. 16.22(b), ordinarily will not be 
less than 3 working days after receipt of the notice, within which to 
request a hearing. Furthermore, under Sec. 16.24(e), the agency has 
changed Sec. 810.11(e) to require that a hearing ordinarily will not be 
held less than 2 working days after receipt of the request for hearing, 
if the request is granted. In accordance with Sec. 16.60(h), the 
Commissioner of Food and Drugs or the presiding officer has the power 
under Sec. 10.19 to suspend, modify, or waive any provision of this 
part. This possibility is reflected in the preamble to the proposed 
rule, which, based on the legislative history, states: ``Where 
warranted, * * * FDA may require that the hearing request be submitted 
in less than 3 days, possibly even on the same day on which the person 
receives the order.'' (See 59 FR 30656 at 30657 and 30658 (citing H. 
Rept. 808, 101st Cong., 2d sess. 29 (1990)).)
    Given the revisions stated above, FDA disagrees that proposed 
Sec. 810.11(e)

[[Page 59009]]

needs to be more clearly defined as to implementation, threshold for 
its use, level of approval needed for this action, or parameters within 
which it can be used. In all but the most extreme circumstances, FDA 
does not intend to exercise its authority to hold an immediate hearing 
under Sec. 810.11(e).
    6. Several comments requested rephrasing proposed Sec. 810.3, which 
relates to computation of time. One comment suggested that it be 
rephrased using the term calendar days. Another comment suggested that 
this section be revised as follows:
    In computing any period of time prescribed or allowed by this 
part, the day of the act or event from which the designated period 
of time begins to run shall not be included. All other calendar 
days, including Saturday and Sunday shall be included. Federal legal 
holidays shall be excluded.
According to this comment, there is no need to build a ``weekend and 
weather'' allowance into the regulation because FDA has in the past 
exercised its judgment when manufacturers have made good faith efforts.
    A comment noted that under proposed Sec. 810.11(a), the requirement 
that a request for a hearing be submitted to FDA within 3 days of 
receipt of FDA's cease distribution and notification order could 
collapse into 1 working day if the order is received on a Friday and 
the computation of time defined in proposed Sec. 810.3 is used. To 
remedy this problem, the comment requested that FDA either: (a) Change 
the computation of time method to working days and retain the 3-day 
period or (b) change the period to 5 days and retain the computation of 
time as calendar days.
    FDA agrees that the computation of time needs to be revised and has 
changed the computation of time method to working days. Accordingly, 
FDA has omitted the ``weekend and weather allowance'' in Sec. 810.3.
    7. Two comments recommended that proposed Sec. 810.10(d)(9) be 
eliminated because it is both inappropriate and outside FDA authority 
to delegate to manufacturers the enforcement responsibility of 
providing to the agency information respecting the names and addresses 
of health professionals or device user facilities that are not in 
compliance with the notification instructions. Another comment stated 
that this section will result in FDA intruding into the practice of 
medicine.
    FDA believes that it is not necessary to include proposed 
Sec. 810.10(d)(9) in the regulation and has deleted that provision from 
the final regulation.
    8. A comment stated that in the preamble of the proposed rule, FDA 
notes that the informal hearing is analogous to a TRO. According to 
this comment, although FDA makes this analogy, FDA fails to note that 
generally persons subject to a TRO are not required to act before the 
hearing. Rule 65(b) of the Federal Rules of Civil Procedure states that 
a TRO may be granted before the adverse party or his attorney can be 
heard in opposition only if ``immediate and irreparable injury, loss, 
or damage will result'' if the restraining order is not granted. 
Accordingly, the comment maintained that in order for FDA to support a 
claim that action is required prior to the informal hearing, FDA must 
demonstrate such immediate and irreparable injury, loss, or damage. 
Moreover, this comment noted that the object of a TRO is to ``preserve 
the status quo.'' Requiring the person subject to a cease distribution 
and notification order to proceed with the actions required by the 
order, before he or she has an opportunity to present the case as to 
why the order is inappropriate, defeats, rather than preserves, the 
status quo.
    FDA disagrees with this comment because it misinterprets the 
legislative history, which does not include an analogy between a cease 
distribution and notification order and a TRO. Rather, it includes an 
analogy between the recall order and a TRO, and the act and the 
regulation both provide for a regulatory hearing before FDA issues a 
recall order. Moreover, the analogy is directed at the quick judicial 
process for TRO's, which ``can result in notice, a hearing and a 
judicial decision in a single day.'' (See H. Rept. 808, 101st Cong., 2d 
sess. 29 (1990).)
    9. Two comments contended that, in a number of instances, the 
language set forth in the preamble is inconsistent with the statutory 
language set forth in the SMDA. Specifically, the comments noted the 
following:
    (a) The preamble to the proposed rule states that: ``The SMDA 
includes provisions designed to expand and strengthen FDA's authority 
to * * * remove dangerous and defective devices from the market 
promptly.'' (See 59 FR 30656 (emphasis added).) According to this 
comment, the phrase ``and defective'' does not appear in section 8 of 
the SMDA, which establishes the agency's mandatory recall authority. 
Thus, the comment recommended eliminating the qualifying phrase ``and 
defective'' from the discussion involving mandatory recalls.
    FDA notes that the term ``dangerous and defective devices'' 
referred to by the comment was used in the preamble to the proposed 
rule with regard to FDA's new authority under the SMDA in general, not 
just FDA's new authority under section 8 of the SMDA for mandatory 
recalls. More importantly, under section 8 of the SMDA, the standard 
for issuance of a cease distribution and notification order applies to 
device hazards generally, whether the devices are dangerous and/or 
defective, provided that they present a reasonable probability of 
causing serious, adverse health consequences or death.
    (b) The preamble also states that section 518 of the act 
``authorizes FDA to require notification of a risk to health presented 
by a medical device.'' (See 59 FR 30656 (emphasis added).) According to 
this comment, the language set forth in section 518 of the act refers 
to an ``unreasonable risk of substantial harm,'' and not a ``risk to 
health'' presented by a medical device. Therefore, the comment 
recommended that FDA adopt the language ``unreasonable risk of 
substantial harm,'' in order to be consistent with section 518 of the 
act.
    FDA notes that the preamble to the proposed rule clearly stated 
that the remedies provided in section 518(a), (b), and (c) of the act 
are available when the agency has determined that the device presents 
an unreasonable risk of substantial harm to the public health.
    (c) In the preamble to the proposed rule, FDA reserved the right to 
amend a cease distribution and notification order to the status of 
mandatory recall order following a finding of inadequate compliance 
with the cease distribution and notification order or a finding that 
the voluntary recall actions are inadequate to eliminate the risk 
without providing the manufacturer an opportunity for an informal 
hearing. Several comments contended that it is inappropriate and 
contrary to Congressional intent to provide the agency with such broad 
discretion relative to amending a cease distribution and notification 
order.
    In response to these comments, FDA has omitted Sec. 810.13(e) from 
the final rule.
    (d) One comment requested that the preamble to the final rule make 
clear that the purpose of the regulatory hearing is not merely to 
determine if a cease distribution order should be revised to require a 
recall, but also to determine if the cease distribution order should be 
otherwise amended or vacated. This revision would make the language set 
forth in the preamble consistent with the language set forth in section 
518(e) of the act, as well as the language set forth in 
Sec. 810.11(b)(1) of the proposed rule.
    The final regulation has been revised to state that the purpose of 
the

[[Page 59010]]

regulatory hearing is to determine whether the order should be 
affirmed, modified, or vacated, or amended to require a mandatory 
recall of the device. (See Sec. 810.11(b).)
    10. A comment alleged that the regulation would limit the ability 
of responsible and well-meaning companies to act independently to 
protect the public health in the face of an ill conceived recall 
action.
    FDA disagrees. In addition to the informal consultation prior to 
the issuance of a cease distribution and notification order, the 
regulatory hearing provided for in Sec. 810.11(a) is the forum in which 
the individual named in the cease distribution and notification order 
can show that the cease distribution and notification order was ill 
conceived. After the hearing the presiding officer can recommend that 
the order be affirmed, modified, or vacated, or amended to require a 
recall. If there is a reasonable probability that death would occur if 
distribution of the device were to cease, the presiding officer may 
recommend to the agency at the conclusion of the hearing that the 
individual named in the order be permitted to distribute the device. 
The agency will base its final decision on the presiding officer's 
report. This process will ensure that individuals will have ample 
opportunity to advise the agency that they believe that a recall under 
consideration is ill conceived.
    11. A comment stated that the rule leaves the following questions 
unanswered:
    (a) What will customers do if they are in the midst of recall 
efforts and then they are informed that a recall has been modified or 
canceled altogether?
    FDA believes that the comment is concerned with what customers 
should do when FDA has issued a cease distribution and notification 
order, the individual named in the order has complied with such order, 
a regulatory hearing has been held, and FDA has vacated the cease 
distribution and notification order. In this circumstance, the 
customers affected by the order may resume using the device as they did 
prior to the issuance of the cease distribution and notification order.
    (b) Is it intended that manufacturers notify their customers 
twice--once about a cease distribution order and later about a recall 
order?
    Yes. According to section 518(e)(1)(B) of the act, under a cease 
distribution and notification order, the individual named in the order 
must, among other things, notify health professionals and device user 
facilities of the order. If FDA subsequently amends the cease 
distribution and notification order to include a recall order, the 
individual named in the order must notify health professionals and 
device user facilities, as well as individuals subject to the risks 
associated with use of the device. (See section 518(e)(2)(B)(ii) of the 
act.)
    12. Several comments recommended that all references to notifying 
or communicating with health professionals, device user facilities, and 
or individuals be replaced with references to notifying or 
communicating with consignees only.
    FDA disagrees. The mandatory recall regulations are being 
established in accordance with the authority granted to FDA under 
section 518(e) of the act. Section 518(e)(1)(B) of the act requires the 
person named in a cease distribution and notification order to 
immediately notify health professionals and device user facilities of 
the order when FDA has determined that the standard for issuance of a 
cease distribution and notification order has been met. Under section 
518(e)(2)(B)(ii) of the act, if the cease distribution and notification 
order is subsequently amended to include a recall order, the person 
named in the order must notify individuals subject to the risks 
associated with the use of the device, including, where appropriate, 
the patients themselves. Thus, under section 518(e) of the act (21 
U.S.C. 360h(e)) FDA may not by regulation limit notification and 
communications to consignees only.

B. Specific Comments

1. Section 810.1
    One comment stated that this section needs to clarify whether 
manufacturers ought to follow the regulation in the event of a 
voluntary recall. In such a case, will FDA impose these regulations in 
addition to voluntary efforts undertaken by manufacturers?
    The answer is no, FDA will not routinely order a mandatory recall 
if a voluntary recall has been effective in addressing the problems. 
Under Sec. 7.3(g), a firm may initiate a voluntary recall of a product 
that is in violation of the laws FDA administers and against which FDA 
would initiate legal action. FDA initiates a mandatory recall under 
section 518(e) of the act when FDA finds that there is a reasonable 
probability that a device would cause serious, adverse health 
consequences or death. Voluntary recalls therefore apply to violative 
devices that may also be subject to mandatory recall because they have 
a reasonable probability of causing serious, adverse health 
consequences or death. A firm may initiate a voluntary recall of a 
violative device without FDA intervention; however, if FDA determines 
that such a voluntary recall is not effective in remedying a violation 
and there remains a reasonable probability that the violative device 
would cause serious, adverse health consequences, FDA will invoke the 
medical device recall authority in addition to the voluntary efforts 
that the manufacturer has already undertaken.
2. Section 810.2(d)
    Two comments stated that including all users within the definition 
of ``consignee'' is too broad. According to one comment, a manufacturer 
or distributor transfers the finished device to the consignee, and 
cannot control, record, or report user identity unless the user is also 
the consignee.
    FDA disagrees. As stated in the preamble to the proposed rule, the 
definition of consignee was based on the definition of consignee found 
in Sec. 7.3. FDA intended the definition of consignee found in Sec. 7.3 
to indicate that a recall may extend not only to customers to whom the 
firm directly shipped the product, but also to those commercial 
establishments that in turn received shipment of the product from the 
first customer. (See 43 FR 26202 at 26210, June 16, 1978.) With the 
exception of those devices that have been identified as tracked 
devices, the agency did not intend to imply that a recalling firm is 
expected or required to know to whom its products are ultimately sold. 
Nor does the agency intend to imply that the person named in the cease 
distribution and notification order is expected or required to know to 
whom its products are ultimately sold. Nevertheless, although the 
manufacturer or distributor may not be able to identify the user, the 
commercial establishment that received the device from the manufacturer 
or distributor and who in turn shipped the device to the user will be 
able to identify the user.
    The definition of ``consignee'' intentionally includes the term 
``used a device'' in the event that a cease distribution and 
notification order or mandatory recall extends to the user level as 
authorized under section 518(e)(2) of the act and Secs. 810.13(b)(1) 
and 810.14(c)(1)(i)(A) of the regulations. Moreover, FDA is clarifying 
that the term ``consignee'' does include health professionals, but does 
not include lay individuals or patients, i.e., nonhealth professionals.
3. Section 810.2(e) and (k)
    A comment requested that the word ``inspection'' be removed from 
the definitions of ``correction'' and ``removal'' because an inspection 
is not

[[Page 59011]]

an intervention making a change to the device as are all the other 
terms included in the definitions.
    FDA disagrees. The term ``inspection'' is properly linked to the 
definitions of ``correction'' and ``removal.'' Although an 
``inspection'' is not an intervention making a change to the device, it 
is a mechanism for ensuring that proper changes to a device have been 
completed in accordance with a cease distribution and notification or 
recall order. Furthermore, in Sec. 7.3(h) of the voluntary recall 
regulations, FDA included the term ``inspection'' in the definition of 
``correction'' to cover those situations in which a device may still be 
used because circumstances would prevent repair or removal of a device, 
e.g., an implanted device, but would nevertheless require positive 
action to ensure the device in use is being properly monitored by a 
physician. (See 43 FR 26202 at 26208, June 16, 1978.) Under the medical 
device recall regulations, an inspection is considered a correction 
under the same circumstances. Finally, FDA has amended the term 
``correction'' to include ``destruction.''
4. Section 810.2(h)
    Two comments noted that the proposed definition of ``reasonable 
probability'' was written in the future tense. As proposed, these 
comments contended, the definition would allow FDA to impose a 
mandatory recall on mere suspicion. Accordingly, these comments 
requested that the definition be written in the past tense.
    FDA disagrees. The main purpose of a cease distribution and 
notification or recall order is to avoid a serious, adverse health 
consequence or death. Accordingly, the likelihood that such harm will 
result from the continued distribution and use of the device, and not 
only the actual occurrence of such a harm, is the appropriate 
definition. The agency therefore adopted the definition of the term 
``reasonable probability'' that is found in the legislative history (S. 
Rept. 513, 101st Cong., 2d sess. 19 (1990)), which is written in the 
future tense. However, FDA does not interpret this to mean that the 
agency can act on ``mere suspicion.'' The agency needs a firm basis for 
issuing an order under part 810, and that basis must be communicated in 
writing to the firm.
5. Section 810.2(i)
    (a) One comment stated that the definition of ``serious, adverse 
health consequences'' is vague. Because the term is the key element 
that determines whether it is appropriate to order a notification or 
recall, it is imperative that the definition be focused and clearly 
stated. In addition, this comment stated that in order to provide some 
consistency among regulatory programs, FDA should make this definition 
relate to the definition of ``serious injury'' in the medical device 
reporting regulations found in 21 CFR part 803.
    FDA disagrees. The definition of ``serious, adverse health 
consequences'' is clearly stated and consistent with congressional use 
of the term in the legislative history. (See S. Rept. 513, 101st Cong., 
2d sess. 19 (1990)). Moreover, this definition is a crucial concept, 
not only for recall authority, but also for two other SMDA provisions: 
Suspension of approval of a premarket approval application and 
postmarket surveillance. Therefore, this definition provides uniformity 
among other SMDA regulatory programs.
    (b) Another comment requested that the term ``serious, adverse 
health consequence'' be redefined as an injury that is not treatable by 
standard medical techniques. The second sentence of the proposed 
definition, ``Injuries attributable to a device that are treatable and 
reversible by standard medical techniques, proximate in time to the 
injury, are not included within the term's definition,'' raises 
unnecessary questions as to the timeframe that must elapse for an 
injury to be deemed irreversible.
    FDA disagrees. However, including the last sentence of the 
definition of ``serious, adverse health consequences'' is superfluous. 
The comparable sentence in the legislative history was intended only to 
further explain the type of injury excluded from the definition of 
serious, adverse health consequences. (See S. Rept. 513, 101st Cong., 
2d sess. 19 (1990).) Accordingly, FDA has revised Sec. 810.2(i) by 
deleting the second sentence.
6. Section 810.2(j)
    (a) One comment recommended that the definition of ``recall'' be 
revised to comply with the current definition of ``voluntary recall,'' 
which restricts recalls to those actions relative to device defects 
``against which the agency would initiate legal action.'' Another 
comment noted that the concept of a recall found in Sec. 7.40 et. seq. 
is much broader than that embodied in this section. According to the 
comment, the proposed rule sets up a confusing inconsistency because it 
does not revise the existing regulation.
    FDA disagrees with these comments. The voluntary recall provisions 
apply not only to medical devices but to all products subject to FDA 
jurisdiction (except electronic products subject only to subchapter C 
of the act). The medical device recall regulations apply only to 
medical devices that have a reasonable probability of causing serious, 
adverse health consequences or death. Thus, the applicability of the 
voluntary recall provisions is necessarily broader than, and the 
criteria for requesting a voluntary recall is purposefully different 
from, that of the medical device recall regulation. Moreover, a recall 
order issued under section 518(e) of the act will include a reference 
to the relevant statute and regulations which should preclude confusion 
between the two recall provisions.
    (b) Another comment stated that it is confusing to include in this 
definition the connection to serious, adverse health consequences, or 
death. Because the term ``recall'' is used in other contexts, a reader 
unfamiliar with the context of the action in question would not be able 
to determine whether the recall was being conducted under this 
authority, under other sections of the act or regulations, or 
voluntarily by the manufacturer. Thus, the comment suggested revising 
the definition as follows: ``Recall means a firm's removal or 
correction of a marketed product.'' This comment also suggested that 
FDA consider modifying Sec. 7.3(g) to read the same as the definition 
suggested above. Additionally, the comment recommended adding the 
following definition: ``Mandatory recall means a recall undertaken 
solely pursuant to an order from FDA which contains a finding that 
there is a reasonable probability that the product(s) involved in the 
recall would cause serious, adverse health consequences or death.'' In 
addition, it was recommended that FDA add a definition of the term 
``voluntary recall'' to Sec. 7.3 to read as follows: ``Voluntary recall 
means a recall of a marketed product undertaken voluntarily by a 
manufacturer when the manufacturer believes that FDA would consider the 
product to be in violation of the laws it administers.''
    FDA disagrees. As stated above, the criteria for initiating a 
voluntary recall are different from the criteria for initiating a 
mandatory recall. FDA included both the criteria for, and the 
definition of, a recall in Sec. 810.2(j) so that individuals would be 
able to determine the type of recall being initiated and to eliminate 
the need to add or amend any recall definitions. Moreover, a recall 
order issued under section 518(e) of the act will include a reference 
to the relevant statute and regulations, thereby eliminating any 
confusion.

[[Page 59012]]

7. Section 810.4
    According to a comment, the magnitude of a mandatory recall or 
cease distribution and notification order is of such significance that 
FDA should not serve such orders by registered mail.
    Overall, FDA agrees with this comment. In most cases, such orders 
will be served in person by a designated FDA employee. However, if FDA 
determines that personal service of the orders will delay section 
518(e) actions, FDA will serve such orders by certified or registered 
mail or similar mail delivery service with a return receipt record 
reflecting receipt.
8. Section 810.10(c)
    (a) According to one comment, it is not appropriate for FDA to 
specify beginning and completion dates for notifying health 
professionals and device user facilities. Depending on how those terms 
are interpreted, a number of factors could affect when an action can 
begin. As a result, this comment suggested deleting this provision.
    FDA disagrees in part. Because cease distribution and notification 
actions are required to begin immediately upon issuance of such an 
order, FDA has determined that it is not appropriate for FDA to specify 
beginning dates for notifying health professionals and device user 
facilities. However, FDA has determined that, under Sec. 810.10(c), FDA 
may include a model letter requiring that notification be completed 
within a specified timeframe. Thus, depending on the circumstances 
surrounding the issuance of such an order, FDA may find it essential 
that the cease distribution and notification order be completed within 
a specified timeframe.
    (b) Another comment suggested that proposed Sec. 810.10(c) be 
revised to include in the order a ``model'' letter that would only 
provide the key elements of information required to inform the customer 
of the situation.
    As suggested by the comment, FDA has amended new Sec. 810.10(c) by 
adding the following sentence: ``The model letter will include the key 
elements of information that the agency in its discretion has 
determined, based on the circumstances surrounding the issuance of each 
order, are necessary to inform health professionals and device user 
facilities about the order.''
9. Sections 810.10(c) and 810.13(b)(4)
    A comment suggested that these sections be revised to indicate that 
the model letter is to ensure compliance with the terms and conditions 
of the cease distribution and notification order or recall order; it is 
not to provide suggested verbiage for the notification of consignees, 
and it is not binding upon medical device manufacturers.
    FDA disagrees. The model letter will be binding on device 
manufacturers. Based on the circumstances of each case, FDA in its 
discretion will determine that the information contained in a model 
letter is necessary to notify health professionals and device user 
facilities of the cease distribution and notification or mandatory 
recall situation. If this information is not included in a 
manufacturer's letter, the manufacturer is not providing adequate 
information to health professionals and device user facilities, and, as 
a result, the person named in the order would not be in compliance with 
the cease distribution and notification order or mandatory recall 
order.
10. Section 810.10(d)
    A comment stated that, under certain circumstances, a manufacturer 
may not be able to provide all of the information specified in proposed 
Sec. 810.10(d). Thus, the comment recommended the following revision: 
``FDA may * * * require the person named in the * * * order to submit 
any or all of the following information by a time specified in the 
order, to the extent it is available or readily ascertainable within 
the time specified by FDA.''
    FDA disagrees. Under Sec. 810.10(d), FDA has the discretion to 
require that the person named in the order submit any or all of the 
specified information. If, in exercising that discretion, FDA 
determines that any or all of the information listed in this section is 
necessary to monitor compliance with the cease distribution and 
notification order, or to determine whether additional action is 
necessary, the person named in the order must submit such information. 
If a particular manufacturer cannot locate certain required information 
because of an uncooperative consignee or other reasons, the 
manufacturer may contact FDA to find out whether there is information 
that it may submit in lieu of the required information. In addition, 
section 518(e) of the act specifically authorizes FDA to issue cease 
distribution and notification orders to appropriate persons, including 
manufacturers, importers, distributors, or retailers. FDA will 
therefore also consider issuing a cease distribution and notification 
order to a manufacturer, importer, distributor, or retailer who does 
not cooperate with a person to whom FDA has issued a cease distribution 
and notification order.
11. Section 810.10(d)(1) and (d)(2)
    A comment noted that proposed Sec. 810.10(d)(1) and (d)(2) seem to 
require the same information. Thus, it was suggested that these 
paragraphs be combined into one information request.
    FDA agrees. However, instead of combining these two paragraphs, FDA 
has revised new Sec. 810.10(d)(1) to read: ``The total number of units 
of the device produced and the timespan of the production.'' This 
change makes this paragraph correspond with Sec. 7.46(a)(4).
12. Section 810.10(d)(3) and (d)(4)
    It was requested that the term ``estimated'' be added to 
Sec. 810.10(d)(3) and (d)(4) to reflect the fact that the numbers 
submitted to FDA can only be estimated by the company. This addition 
would be similar to the use of the term ``estimated'' in 
Sec. 810.10(d)(2).
    FDA agrees and has revised the sections accordingly.
13. Section 810.10(d)(5)
    Section 810.10(d)(5) uses the term ``direct'' consignee. Section 
810.2(d), which defines consignee, does not refer to a distinction 
between a direct consignee and a consignee. Accordingly, it was 
suggested that FDA either: (1) Add a definition for direct consignees 
or (2) modify the term consignee to include only direct consignees and 
delete the word direct from this section.
    FDA has removed the term ``direct'' from this section. Thus, this 
section applies to all consignees as defined in Sec. 810.2(d). As 
stated previously in section IV.B.2. of this document, FDA did not 
intend to imply that the person named in the cease distribution and 
notification order or recall order is expected or required to know to 
whom its products are ultimately sold. However, although the 
manufacturer or distributor may not be able to identify all consignees, 
the commercial establishment that received the device from the 
manufacturer or distributor and who in turn shipped the device to a 
subsequent consignee will be able to identify the subsequent consignee.
14. Section 810.10(d)(8)
    A comment stated that it is unnecessary to require the times 
individuals were contacted under the cease distribution and 
notification order. Accordingly, the comment suggested striking the 
phrase ``and times'' from this section. Moreover, it was suggested that 
the phrase ``names of specific individuals contacted within user 
facilities'' be eliminated in its entirety.
    FDA agrees that requiring the person named in the cease 
distribution and

[[Page 59013]]

notification order to document the ``times'' that specific individuals 
within device user facilities were contacted is unnecessary. Providing 
FDA with the dates of such contacts is sufficient. FDA has amended this 
section accordingly. FDA disagrees, however, that the phrase ``names of 
specific individuals contacted within user facilities'' should be 
eliminated. Requiring such information will ensure against allegations 
of failure to notify device user facilities. If a question concerning 
notification of a user facility arises, FDA can simply contact the 
person listed as the ``specific individual contacted within the user 
facility'' to determine if he/she received notification.
15. Section 810.10(e)
    A comment stated that a definition of the term ``opportunity'' 
should be added because there is a very short time from issuance of the 
order to the hearing and because there is only one hearing.
    FDA disagrees. The agency believes that Sec. 810.11 as amended, 
which establishes the procedures to be followed in requesting a 
regulatory hearing, implicitly explains the term ``opportunity.''
16. Section 810.11(b)(2)
    A comment noted that this section omits language set forth in the 
statute that indicates that FDA may vacate the cease distribution and 
notification order should the agency determine that inadequate grounds 
exist to support the actions required by the order. Thus, the comment 
would append the following language to Sec. 810.11: ``Sec. 810.11(g)--
If, after providing an opportunity for such a hearing, whether acted 
upon or not, the Secretary determines that inadequate grounds exist to 
support the actions required by the order, the Secretary shall vacate 
the order.''
    FDA disagrees. Appending the recommended language is unnecessary 
because Sec. 810.11(b)(1) already addresses this issue.
17. Section 810.11(c)
    (a) According to Sec. 810.11(c), Secs. 16.60(h) and 10.19 apply to 
the regulatory hearings provided under the medical device recall 
authority. These sections permit the waiver, suspension, or 
modification of any otherwise applicable procedure in part 16. A 
comment requested that it be explicitly stated in the regulation that 
this flexibility does not permit the waiver of the opportunity for a 
regulatory hearing itself, since that right is guaranteed by section 
518(e) of the act.
    Another comment stated that the intent expressed in proposed 
Sec. 810.11(c) seems to be beyond the scope of Sec. 10.19, which states 
that a provision of part 16 may be waived, suspended, or modified only 
if ``no participant will be prejudiced.'' According to the comment, 
under part 810, it is difficult to see how a manufacturer would not be 
prejudiced by any action that reduces or eliminates its procedural and 
substantive rights.
    FDA disagrees with these comments. Under Sec. 810.11(c), a part 16 
procedure may be waived, suspended, or modified in accordance with 
Sec. 10.19. Under Sec. 10.19, a part 16 procedure may be waived, 
suspended, or modified if a participant will not be prejudiced, the 
ends of justice will be served, and the action is in accordance with 
the law. Moreover, section 518(e)(1) of the act requires FDA to provide 
the person subject to a cease distribution and notification order with 
an opportunity for a regulatory hearing. Under 21 CFR 16.26, the 
Commissioner of Food and Drugs or the presiding officer may deny, in 
whole or in part, a request for a hearing if he or she determines that 
the material submitted in support of the request raises no genuine and 
substantial issue of fact. Therefore, no person subject to a cease 
distribution and notification order will be denied the opportunity for 
a regulatory hearing. If such person fails to raise a genuine and 
substantial issue of fact in requesting a hearing, however, he or she 
may be denied a hearing. In addition, once a regulatory hearing 
commences, the presiding officer may issue a summary decision on any 
issue if he or she determines that there is no genuine and substantial 
issue of fact respecting that issue.
    Congress intended that FDA be able to give notice, hold an informal 
hearing, and render a decision on a recall in a single day, if 
``circumstances require expedited action,'' i.e., when FDA believes 
that immediate action is necessary to protect the public health. (See 
H. Rept. 808, 101st Cong., 2d sess. 29 (1990).) (See also 61 FR 15186, 
April 5, 1996.) Although Sec. 810.11 provides that recall hearings will 
not generally be conducted fewer than 5 days after notice is given by 
the cease distribution and notification order, the person named in a 
cease distribution and notification order has no procedural right under 
the statute to 5 days notice of the hearing. Section 810.11(c) 
therefore properly reserves discretion for the Commissioner or 
presiding officer to suspend, waive, or modify the procedural 
provisions of part 16, including those pertaining to the timing of the 
hearing.
    (b) Another comment stated that FDA seems to be overstating the 
scope of its authority under Secs. 16.60(h) and 10.19. As proposed, 
Sec. 810.11(c) stated that ``the agency may waive, suspend, or 
modify,'' whereas Sec. 16.60(h) states that only the ``Commissioner or 
the presiding officer has the power to suspend, modify, or waive any 
provision'' in part 16. In addition, as proposed, Sec. 810.11(c) stated 
that any ``procedure'' may be waived, suspended, or modified, while 
Sec. 16.60(h) refers only to ``any provision of this part.''
    FDA agrees and has amended Sec. 810.11(c) to conform to 
Secs. 16.60(h) and 10.19.
18. Section 810.11(e)
    A comment maintained that due process concerns dictate that the 10-
day period before a hearing will be held beginning on the date of 
receipt, rather than the date of issuance of the order.
    FDA disagrees. Given the exigent circumstances surrounding the 
issuance of cease distribution and notification orders, it is 
appropriate that the holding of a regulatory hearing be calculated 
based on the date of issuance of such orders. Moreover, section 
518(e)(1) of the act requires that regulatory hearings be held no later 
that 10 days after issuance of such orders. However, as set forth in 
Sec. 810.3, the day of issuance will not be included in the 10-day time 
period.
19. Sections 810.13, 810.14, and 810.15
    According to one comment, proposed Secs. 810.13, 810.14, and 810.15 
should be revised to emphasize that the provisions are intended as 
guidance and are not mandatory. Orders should be tailored to specific 
circumstances and should be as flexible as possible both in their 
formulation by FDA and in their implementation by the respondent.
    FDA believes that these sections are already tailored to address 
the specific circumstances surrounding the issuance of each order. 
Although some aspects of a recall order, a cease distribution and 
notification or mandatory recall strategy, and communications 
concerning a cease distribution and notification or mandatory recall 
order are mandatory, some aspects vary depending on the order. Instead 
of having specific and rigid instructions to cover all orders, FDA 
believes these sections include only the basic elements of each. For 
instance, according to Sec. 810.13(b), FDA has discretion in 
determining what is appropriate for a recall order based on the 
individual circumstances. Moreover, Sec. 810.14(a) states that ``[t]he 
person named in a cease distribution and notification order * * * or a 
mandatory recall order * * * shall develop a strategy * * * that is

[[Page 59014]]

appropriate for the individual circumstances * * *.'' Finally, 
Sec. 810.15(a) states that ``[t]he person named in a cease distribution 
and notification order * * * or a mandatory recall order * * * is 
responsible for promptly notifying each health professional, device 
user facility, consignee, or individual, as appropriate, of the 
order.'' Thus, a recall order, a cease distribution and notification or 
mandatory recall strategy, and the communications concerning the cease 
distribution and notification order or mandatory recall order will vary 
depending on the circumstances surrounding the issuance of each order.
20. Section 810.13(b)(2)
    Two comments stated that it is virtually impossible for a 
manufacturer or FDA to predict with any degree of accuracy when a 
recall will be completed. Under the current voluntary recall provision, 
a manufacturer may request termination of a recall by demonstrating 
that the recall has been effective (Sec. 7.55). Thus, the comments 
suggested that proposed Sec. 810.13(b)(2) be revised to read that FDA 
may specify a timetable in accordance with which the recall is to occur 
and to reference the recall termination procedures from Sec. 810.17, 
instead of specifying a timetable in which the recall is to be 
completed.
    FDA disagrees. Section 810.13(b) states: ``In a mandatory recall 
order, FDA may * * * (2) Specify a timetable in accordance with which 
the recall is to begin and be completed.'' This section is in 
accordance with the recall authority legislative history, which states: 
``The bill does not have specific timetables under which recalls must 
occur * * *; the Committee believes that it is more appropriate to 
allow the Secretary, dependent on the circumstances of each case, to 
establish the time-frames for completion of the recall.'' (See S. Rept. 
513, 101st Cong., 2d sess. 20 (1990)). FDA believes that this section, 
as drafted, vests with the agency the discretion to establish recall 
completion dates that depend on the facts surrounding the issuance of 
each order, in conformance with legislative intent. It is therefore 
unnecessary for this section to reference the termination procedures 
set out in Sec. 810.17.
21. Section 810.13(c)(2)
    A comment suggested that all references to a competitor's product 
be eliminated from this subsection. The decision to replace a defective 
device with a competitor's product poses conflict of interest concerns 
for both the agency and manufacturer.
    In response to this comment, FDA has deleted any reference to 
``competitor's product'' from Sec. 810.13(c)(2). FDA will not 
explicitly reference a competitor's product in mandatory recall orders. 
However, the agency may consider availability of alternate products, 
including those produced by competitors, when determining whether to 
amend a cease distribution and notification order to require a recall. 
Clearly, the availability of alternate products is an important and 
relevant factor that FDA may consider in comparing the risk of 
recalling the device with the risk of not recalling it.
22. Section 810.13(e)
    (a) A comment noted that if FDA can issue a mandatory recall, after 
initially deciding not to issue one, based on noncompliance with the 
cease distribution and notification order, then the findings of the 
regulatory hearing become moot. Another comment stated that 
``noncompliance with the cease distribution and notification order'' 
should be determined on a case-by-case basis. Another comment requested 
that this section be deleted because, according to this comment, it is 
clear that Congress did not intend for FDA to have the unilateral 
authority to issue a mandatory recall order without notice and 
participation of the affected party through appropriate due process 
protections such as a regulatory hearing.
    As stated in section IV.A. of this document, FDA has omitted 
Sec. 810.13(e) from the final rule in response to comments.
23. Sections 810.14(a)(5) and 810.17(b)(1)
    According to two comments, proposed Sec. 810.14(a)(5) should state 
clearly that the information sought only concerns the effectiveness of 
the level of the manufacturer's notification, rather than the intrusion 
into the practice of medicine by the manufacturer to determine the 
extent to which the health professionals and device user facilities are 
complying with instructions. Thus, these comments suggested revising 
this section to read as follows: ``The extent to which notification and 
instruction of health professionals and user facilities has been 
achieved.''
    Proposed Sec. 810.14(a)(5) required that the firm consider 
information about the success of efforts to inform users to cease use 
of the device, and FDA has determined that this information will not 
generally be available to the firm by the time it must submit its 
strategy to FDA. Therefore, FDA has deleted this section from the 
general provision part of the final regulation.
    Two comments stated that Sec. 810.17(b)(1) needs to omit any 
suggestion that the manufacturer has the legal requirement to ensure 
that all health professionals, device user facilities, consignees, and 
applicable individuals have complied with instructions to cease the use 
of the device because manufacturers are not required to monitor 
compliance with the order.
    FDA agrees in part with the comment. In proposing 
Sec. 810.17(b)(1), FDA did not intend to suggest that the manufacturer 
is legally required to ensure that all health professionals, device 
user facilities, consignees, and, where appropriate, individuals have 
complied with the cease distribution and notification order. FDA did 
intend, however, to require the manufacturer to verify that health 
professionals, device user facilities, consignees, and, where 
appropriate, individuals have been notified of the cease distribution 
and notification order and have been instructed to take appropriate 
action, and FDA has amended Sec. 810.17(b)(1) to clarify it. FDA 
considers such verification the responsibility of the person named in 
the order. Requiring such verification under Sec. 810.17(b)(1) assures 
the public that FDA has determined that all reasonable efforts have 
been made to implement the cease distribution and notification order.
24. Section 810.14(a)(7) (renumbered Sec. 810.14(b)(2) in the final 
regulation)
    (a) According to a comment, this section grants FDA undue 
discretion to review the elements of a proposed recall strategy. This 
comment stated that FDA's authority to review and modify a 
manufacturer's recall strategy must be limited to the power to require 
modifications that ensure that the recall is effective in addressing 
serious, adverse health consequences or death.
    FDA believes that Sec. 810.14 provides the agency with the 
discretion necessary to effect the statutory purpose. Each cease 
distribution and notification order modified under Sec. 810.11(e) or 
Sec. 810.12(c) or recall order requires devising a specific course of 
action to implement the order. In developing a strategy for either a 
cease distribution and notification order modified under Sec. 810.11(e) 
or Sec. 810.12(c) or a recall order, the person named in the order must 
take into account the factors listed in Sec. 810.14(a) and meet the 
requirements listed in Sec. 810.14(c) of the final regulation. FDA will 
review the adequacy of the strategy proposed by the person named in the 
order. (See

[[Page 59015]]

Sec. 810.14(b)(2).) If the person named in the order has appropriately 
considered all the factors listed in Sec. 810.14(a) and included the 
requirements listed in Sec. 810.14(c), FDA will find the strategy 
acceptable. When the agency in its discretion finds that the person 
named in the order has not given appropriate consideration to relevant 
factors (Sec. 810.14(a)) and requirements (Sec. 810.14(c)), FDA will 
mandate changes in the strategy. FDA's authority to review and modify a 
manufacturer's strategy therefore allows it to require modifications 
that ensure that the cease distribution and notification strategy or 
mandatory recall strategy will be effective in addressing serious, 
adverse health consequences or death.
    (b) The comment also stated that, to the extent that 
Sec. 810.14(b)(2) allows FDA to impose a strategy on the manufacturer, 
it is unreasonable. At a minimum, FDA should consult with the 
individuals responsible for the strategy prior to making any changes to 
the strategy or should provide the manufacturer with an opportunity to 
have a hearing on the reasonableness and appropriateness of a proposed 
strategy. Moreover, it is unreasonable for FDA to require the 
manufacturer to begin to implement the submitted strategy before FDA 
has reviewed it.
    FDA agrees in part with the comment and has amended proposed 
Sec. 810.14(b)(2) accordingly. Section 810.14(b)(2) now states that the 
agency will complete review of a proposed strategy for a cease 
distribution and notification order modified under Sec. 810.11(e) or 
Sec. 810.12(c) within 7 days of receipt. The person named in the order 
shall act in accordance with a strategy only after FDA has determined 
that the strategy is appropriate.
    FDA disagrees, however, that the agency should provide the 
manufacturer with an opportunity to have a hearing on the 
reasonableness and appropriateness of a proposed strategy. An 
additional hearing to address the appropriateness of the firm's 
proposed strategy cannot be granted because of the exigent 
circumstances surrounding the issuance of such orders. However, under 
Secs. 810.11(b)(1) and 810.12(b), the regulatory hearing and written 
request for review may address the actions required by the cease 
distribution and notification order, including an appropriate cease 
distribution and notification strategy if the cease distribution and 
notification order is modified. Furthermore, under Secs. 810.11(b)(2) 
and 810.12(b), the regulatory hearing and written request for review 
may also address whether FDA should amend the order to require a 
recall, including an appropriate recall strategy if FDA should 
determine that a recall is warranted.
    (c) According to the comment, proposed Sec. 810.14(a)(6) and (a)(7) 
are not appropriate factors to be considered in developing a cease 
distribution and notification or recall strategy. Thus, the comment 
suggested that proposed Sec. 810.14(a)(6) and (a)(7) be removed from 
the list of factors to be considered and be included in another 
paragraph, i.e., paragraph (b).
    The agency agrees. FDA has therefore renumbered paragraph (a)(6) 
and (a)(7) as (b)(1) and (b)(2), respectively, under a new paragraph 
(b) heading ``Submission and review.'' Accordingly, current paragraph 
(b) has been renumbered as paragraph (c).
25. Section 810.14(b)(3) (renumbered Sec. 810.14(c)(3))
    One comment stated that a manufacturer's responsibility to conduct 
effectiveness checks should be limited to direct consignees. Another 
comment recommended that the word ``all'' be deleted from the first 
sentence because it would be virtually impossible for a recall strategy 
to verify that ``all'' of the target audience was actually reached. 
Instead, it was suggested that the regulation require that an 
appropriate level of effectiveness checks be established in advance of 
the strategy.
    FDA disagrees that a manufacturer's responsibility to conduct 
effectiveness checks should be limited to direct consignees. The 
purpose of effectiveness checks is to verify that all known, affected 
consignees have received notification about a particular recall order. 
Thus, if a recall extends to the user level, as authorized by 
Sec. 810.13(b)(1), it is imperative that all known affected consignees, 
direct and indirect, receive notification of the order. For these same 
reasons, FDA disagrees with deleting the word ``all'' from the first 
sentence.
    FDA recognizes, however, that in some instances the person named in 
the recall order may not be able to check the effectiveness of its 
recall; for example, manufacturers, importers, distributors, or 
retailers may not cooperate. In such cases, FDA will directly assist in 
the effectiveness check activity and, where necessary, seek assistance 
from cooperating State and local agencies. In addition, as stated 
previously, section 518(e) of the act specifically authorizes FDA to 
issue cease distribution and notification orders to appropriate 
persons, including manufacturers, importers, distributors, or 
retailers. FDA will therefore also consider issuing a cease 
distribution and notification order to a manufacturer, importer, 
distributor, or retailer who does not cooperate with a person to whom 
FDA has issued a cease distribution and notification order.
26. Section 810.15(b)
    According to a comment, limiting the communications to written 
notices is unduly restrictive. Therefore, this comment suggested 
revising this section to specify that telephonic or other electronic 
means of communication may be used when appropriate.
    FDA disagrees. Requiring communication by verified written notice 
ensures that the person named in the order will have written proof of 
notification if a question of noncompliance is raised. However, the 
person named in an order may utilize telephonic or electronic means in 
addition to verified written notices.
27. Section 810.15(e)
    According to one comment, under section 518(e) of the act only 
those persons who have been provided with notice and an opportunity for 
a hearing on a cease distribution and notification or mandatory recall 
order are legally bound by such an order. Thus, this section should be 
modified to state that recipients of a communication concerning a cease 
distribution and notification or a mandatory recall order are 
instructed to take appropriate actions, rather than create the 
impression that they are legally obligated to do so.
    FDA has used the term ``should'' instead of ``shall'' throughout 
this section in order to encourage recipients of such communications 
who are not otherwise legally obligated by a cease distribution and 
notification or mandatory recall order to take appropriate actions 
under the order. Furthermore, FDA considers such orders strong 
advisories for health professionals. FDA anticipates that health 
professionals will exercise their best clinical judgment in deciding 
whether ceasing use of the medical device is in the best interest of 
their patients based on the information available to them as well as 
the availability of alternate devices.
28. Section 810.16(b)(1) through (b)(4)
    One comment finds that the references to ``individuals'' contacted 
about the order in these sections is confusing given the fact that 
section 518(e) of the act and Sec. 810.13(c)(1) provide that no 
mandatory recall order will be issued to individuals. Thus, the comment 
recommended deleting the term ``individuals'' from this section.

[[Page 59016]]

    FDA disagrees. Section 518(e)(2)(B)(i)(I) of the act and 
Sec. 810.13(c)(1) provide that a mandatory recall order will not 
require recall of a device from an individual. However, section 
518(e)(2)(B)(ii) of the act and Sec. 810.13(d) state that a mandatory 
recall order will provide notice to individuals subject to the risks 
associated with use of the recalled device. Therefore, the reference to 
``individuals'' in these sections is appropriate because it applies to 
notification of risk, not to product recall.
29. Section 810.16(b)(6)
    A comment suggested that the timeframes be arrived at as the result 
of a collaborative dialogue between the agency and the person named in 
the cease distribution and notification or mandatory recall order, 
rather than be imposed by FDA. Another comment stated that because it 
is not possible to predict the completion of a recall, the section 
should be revised to read: ``Estimated time-frame for completion of the 
requirements of the cease distribution and notification order.''
    FDA does not believe that collaborative dialogue between FDA and 
industry is foreclosed by Sec. 810.16(b)(6), which merely requires that 
status reports on cease distribution and notification orders and recall 
orders, which the person subject to the order submits to FDA, contain 
estimated timeframes for completion of the requirements of cease 
distribution and notification orders, if warranted, and mandatory 
recall orders as required under section 518(e)(2)(A) of the act. (See 
Secs. 810.10(c) and 810.13(b)(2).) Moreover, the hearing under 
Sec. 810.11 will provide an opportunity to review actions required by 
both orders, including the timeframes for completion of those actions. 
FDA does expect all recall-related activity to be completed and final 
status reports submitted for termination within 6 months of issuance of 
recall orders. FDA therefore disagrees with the comment that suggests 
revision of this section to eliminate reference to mandatory recall 
orders.
30. Section 810.18
    A comment stated that FDA should be required to publish any 
mandatory recall in the FDA Enforcement Report within 30 days of the 
recall order or cease distribution and notification order. If the 
recall is listed in the FDA Enforcement Report within 30 days of the 
recall notification letter to consignees, then the relationship between 
the two notifications will be apparent to all interested parties.
    Although FDA agrees it is desirable to list mandatory recall 
information in the weekly Enforcement Report as soon as possible, there 
are a number of factors, some of which the agency may not control, that 
determine when the agency has sufficient information to list a recall 
on the weekly FDA Enforcement Report. These factors will vary from one 
case to another. Because of this variation, it is not always possible 
to predict and schedule the exact time the agency will be able to list 
publicly a particular recall. Moreover, in limited circumstances, FDA 
may intentionally delay public notification of recalls of certain 
devices when the agency determines that public notification may cause 
unnecessary harm and anxiety to patients and that initial consultation 
between patients and their doctors is essential.

V. Summary of Changes from the Proposed Rule

    Although the agency maintained the basic framework of the proposed 
rule, FDA modified the proposed rule to address concerns raised in the 
comments.
    In response to concerns raised in the comments, FDA made the 
following changes:
    (1) If, after providing the appropriate person with an opportunity 
to consult with the agency, FDA finds that there is a reasonable 
probability that a device intended for human use would cause serious, 
adverse health consequences or death, the agency may issue a cease 
distribution and notification order (Sec. 810.10(a)).
    (2) FDA will be given 15 working days to complete its deliberative 
process following the completion of a regulatory hearing 
(Sec. 810.11(e)) or receipt of a written request for review of a cease 
distribution and notification order (Sec. 810.12(c)). Accordingly, 
under Sec. 810.13(a), FDA will amend a cease distribution and 
notification order to include a mandatory recall within 15 working days 
of issuance of the cease distribution and notification order if a 
regulatory hearing or agency review of the order is not requested, or 
within 15 working days of denying a request for a hearing, or within 15 
working days after completing a regulatory hearing, or within 15 
working days of receipt of a written request for review of a cease 
distribution and notification order.
    (3) Amended Sec. 810.12(a) provides that the individual submitting 
a written request for review of a cease distribution and notification 
order must submit such a request within the timeframe specified in the 
order which will be, in most cases, within 10 working days of issuance 
of such an order, but not generally less than 3 working days after 
receipt of the cease distribution and notification order. This 
amendment is consistent with: (a) Section 810.11(a) which requires that 
a request for a regulatory hearing be submitted in writing within the 
timeframe specified by FDA (which under Sec. 16.22(b), will not 
ordinarily be less than 3 working days after receipt of the cease 
distribution and notification order); and (b) Sec. 810.11(e) which 
requires a regulatory hearing to be held within 10 working days of 
issuance of a cease distribution and notification order.
    (4) Under Sec. 810.14(b)(2), the agency will review and amend, 
reject, or accept a proposed strategy for a cease distribution and 
notification order modified under Sec. 810.11(e) or Sec. 810.12(c) or a 
mandatory recall within 7 working days of receipt of such a strategy.
    (5) According to Sec. 810.17(c), FDA will respond to a written 
request for termination of a cease distribution and notification or 
recall order within 30 working days of its receipt.
    (6) FDA clarified that the opportunity for a regulatory hearing 
provided for in Sec. 810.11 will be subject to the provisions set out 
in part 16 by making the following amendments:
    (a) The agency has changed Sec. 810.11(a) to provide that the 
person offered an opportunity for a hearing has the amount of time 
specified in the cease distribution and notification order to request a 
hearing. In accordance with Sec. 16.22(b), FDA will ordinarily not 
require that such request be made in fewer than 3 working days after 
receipt of the order.
    (b) Under Sec. 16.24(e), the agency has changed Sec. 810.11(e) to 
provide that a hearing will ordinarily not be held fewer than 2 working 
days after receipt of the request for hearing. Thus, the person named 
in the cease distribution and notification order will generally have at 
least 5 working days following receipt of the order before a regulatory 
hearing is held, unless FDA and the person named in the order agree to 
a later date or the presiding officer determines otherwise. Moreover, 
in accordance with Sec. 16.60(h), the Commissioner of Food and Drugs or 
the presiding officer has the power under Sec. 10.19 to suspend, 
modify, or waive any provision of part 16.
    (c) The agency has referenced Sec. 16.26(a) and (b) in 
Sec. 810.11(a) and (c) to clarify that a request for a regulatory 
hearing may be denied in whole or in part and that a summary decision 
on an issue may be issued once a regulatory hearing commences if there 
is no

[[Page 59017]]

genuine and substantial issue of fact raised in the request for a 
hearing or about an issue once a hearing commences. The agency has 
amended Sec. 810.11(b) and (c) to clarify that they apply if the agency 
grants a request for a regulatory hearing.
    (7) FDA revised the definition of serious, adverse health 
consequences in Sec. 810.2(i) by deleting the second sentence in the 
proposed definition.
    (8) FDA clarified the definition of consignee in Sec. 810.2(d).
    (9) In Sec. 810.3, FDA changed the computation of time method to 
working days.
    (10) FDA revised Sec. 810.4 so that a cease distribution and 
notification order or recall order will be served in person by a 
designated FDA employee in most cases.
    (11) FDA deleted proposed Sec. 810.10(d)(9) from the final 
regulation and has redesignated proposed Sec. 810.10(d)(10) as 
Sec. 810.10(d)(9) in the final regulation.
    (12) FDA amended Sec. 810.11(a), (c), and (e) to conform to 
Secs. 16.60(h) and 10.19.
    (13) FDA deleted Sec. 810.14(a)(5) from the final regulation 
because the information sought under this section will not generally be 
available to the firm by the time it must submit its strategy to FDA.
    (14) FDA renumbered proposed Sec. 810.14(a)(6) and (a)(7) as 
Sec. 810.14(b)(1) and (b)(2), respectively, under a new paragraph (b) 
heading entitled ``Submission and review'' in the final regulation. As 
a result of this modification, FDA has renumbered proposed 
Sec. 810.14(b) as Sec. 810.14(c) under the same paragraph (c) heading 
``Elements of the strategy.''
    (15) FDA amended various paragraphs of Sec. 810.10. First, FDA 
revised Sec. 810.10(d)(1) to read: ``The total number of units of the 
device produced and the timespan of the production.'' Second, FDA added 
the term ``estimated'' to Sec. 810.10(d)(3) and (d)(4).
    (16) FDA removed the term ``direct'' from Sec. 810.10(d)(5).
    (17) FDA omitted from the final rule Sec. 810.13(e) which provided 
FDA with the authority to initially determine that a cease distribution 
and notification order need not be amended to require a mandatory 
recall, but subsequently amend the order to require a recall of the 
device if the agency made specific findings. Under the final rule, if 
FDA initially determines that a device does not pose a reasonable 
probability of causing serious, adverse health consequences or death, 
the agency will vacate the order. If, however, FDA subsequently finds 
that the device, which was subject to the original cease distribution 
and notification order which was vacated, poses a reasonable 
probability of causing serious, adverse health consequences or death, 
the agency will issue a new cease distribution and notification order. 
If a new cease distribution and notification order is issued, the 
person subject to the order will be provided with the opportunity for a 
regulatory hearing as required by section 518(e)(1) of the act and 
Sec. 810.11 of the regulation or with the opportunity to submit a 
written request for review of a cease distribution and notification 
order under Sec. 810.12 of the regulation.

VI. Environmental Impact

    The agency has determined under 21 CFR 25.24(a)(8) that this action 
is of a type that does not individually or cumulatively have a 
significant effect on the human environment. Therefore, neither an 
environmental assessment nor an environmental impact statement is 
required.

VII. Analysis of Impacts

    FDA has examined the impacts of the final rule under Executive 
Order 12866, the Regulatory Flexibility Act (Pub. L. 96-354), as 
amended by Subtitle D of the Small Business Regulatory Fairness Act of 
1996 (Pub. L. 104-121), and the Unfunded Mandates Reform Act of 1995 
(Pub. L. 104-4). Executive Order 12866 directs agencies to assess all 
costs and benefits of available regulatory alternatives and, when 
regulation is necessary, to select regulatory approaches that maximize 
net benefits (including potential economic, environmental, public 
health and safety, and other advantages; distributive impacts; and 
equity). The agency believes that this final rule is consistent with 
the regulatory philosophy and principles identified in the Executive 
Order. In addition, the final rule is not a significant regulatory 
action as defined by the Executive Order and so is not subject to 
review under the Executive Order.
    The Regulatory Flexibility Act requires agencies to analyze 
regulatory options that would minimize any significant impact of a rule 
on small entities. A comment stated that this rule will have a 
significant impact on small entities. Thus, the comment stated that 
further analysis under both Executive Order 12866 and the Regulatory 
Flexibility Act is warranted.
    FDA disagrees with this comment. FDA has examined the rule under 
the Regulatory Flexibility Act and Executive Order 12866. The rule 
merely establishes the procedures by which FDA will implement its 
authority for the cessation of distribution and use and recall of a 
device. FDA cannot predict the cost of any action that would be ordered 
under this rule. However, FDA believes that it has provided sufficient 
flexibility in the rule so as to minimize the burden on those required 
to take action consistent with the determination that the device 
presents a risk of serious adverse health consequences or death. For 
example, Sec. 810.10(a) provides entities with an opportunity to 
consult with FDA before FDA issues a cease distribution and 
notification order. In addition, Sec. 810.11 provides an opportunity 
for a regulatory hearing and Sec. 810.12 provides an opportunity for 
written review of an order. Lastly, Sec. 810.14 provides that the 
person required to carry out the recall order may develop a strategy 
for carrying out a recall subject to FDA review. These provisions will 
provide entities with the opportunity to advise the agency about cost 
effective means to protect the public health.
    The agency believes that only a small number of firms will be 
affected by this rule. Under this rule, the agency would invoke section 
518(e) of the act in those instances that match very closely the 
definition of class I recall, where there is a strong likelihood that 
the use of or exposure to a device would cause serious, adverse health 
consequences or death (compare Sec. 7.3(m)(1) and section 518(e)). The 
greatest number of class I recalls in 1 year to date has been 36, and 
the average over the last 5 fiscal years has been 19 per year. FDA 
expects that almost all of the recalls will continue to be carried out 
under the voluntary recall, part 7 procedures. The agency expects that 
at most one or two recalls per year would be ordered that would not 
have occurred without this regulation. Thus, the agency believes that 
this new authority will not be used frequently. The agency is unable to 
estimate the cost of this rule because it is unable to predict the 
nature or size of recalls that may be ordered. FDA believes, however, 
that the costs will not be excessive for the recall of a device that 
presents a risk of serious adverse health consequences or death, given 
the limited number of recalls that will be ordered and the flexibility 
that is allowed to implement them. For these reasons, the Commissioner 
certifies that the final rule will not have a significant economic 
impact on a substantial number of small entities. Therefore, under the 
Regulatory Flexibility Act, no further analysis is required. In 
addition, this rule will not impose expenditures of $100 million or 
more on either State,

[[Page 59018]]

local, and tribal governments in aggregate or the private sector, and 
therefore a written statement under section 202(a) of the Unfunded 
Mandates Reform Act of 1995 is not required.

VIII. Congressional Review

    This rule is not a major rule under the congressional review 
provisions of Subtitle E of the Small Business Regulatory Fairness Act 
of 1996 (Pub. L. 104-121).

IX. Paperwork Reduction Act of 1995

    This final rule contains information collections which are subject 
to review by OMB under the Paperwork Reduction Act of 1995 (Pub. L. 
104-13). The title, description, and respondent description of the 
information collections and an estimate of the annual reporting burden 
are shown below. Included in the estimate is the time for searching 
existing data sources, gathering and maintaining data needed, and 
completing and reviewing the collection of information.
    Title: Reporting requirements for individuals named in cease 
distribution and notification orders and mandatory recall orders under 
the SMDA.
    Description: This regulation establishes the procedures for 
implementing the medical device recall authority provided in the SMDA. 
The purpose of this regulation is to protect the public health by 
permitting FDA to promptly cease distribution of and recall dangerous 
devices from the market.
    Description of Respondents: Businesses or other for profit 
organizations.
    Although the June 14, 1994, proposed rule provided a 90-day comment 
period, and this final rule is based on the comments received, the 
proposed rule has not been previously available to OMB for review. 
Therefore, as required by section 3507(d) of the Paperwork Reduction 
Act of 1995, FDA will submit a copy of this final rule to OMB for 
review and approval of these information collection requirements. 
Organizations and individuals may submit comments on the information 
collection requirements by January 21, 1997. FDA particularly invites 
comments on: (1) Whether the proposed collection of information is 
necessary for the proper performance of FDA's functions, including 
whether the information will have practical utility; (2) the accuracy 
of FDA's estimate of the burden of the collection of information, 
including the validity of the methodology and assumptions used; (3) 
ways to enhance the quality, utility, and clarity of the information to 
be collected; and (4) ways to minimize the burden of the collection of 
information on respondents, including through the use of automated 
collection techniques when appropriate, and other forms of information 
technology. Comments should be directed to the Dockets Management 
Branch (address above).
    At the close of the 60-day comment period, FDA will review the 
comments received, make revisions as necessary to the information 
collection requirements, and submit the requirements to OMB for review 
and approval. Additional time will be allotted for public comment to 
OMB on the requirements and OMB review. Prior to the effective date of 
this final rule, FDA will publish a notice in the Federal Register of 
OMB's decision to approve, modify, or disapprove the information 
collection requirements. An agency may not conduct or sponsor, and a 
person is not required to respond to, a collection of information 
unless it displays a currently valid OMB control number.

                                   Table 1.--Estimated Annual Reporting Burden                                  
----------------------------------------------------------------------------------------------------------------
                                                      Annual                                                    
         21 CFR Section               No. of       Frequency per   Total Annual      Hours per      Total Hours 
                                    Respondents      Response        Responses       Response                   
----------------------------------------------------------------------------------------------------------------
810.10(d)                               2               1               2               8              16       
810.11(a)                               1               1               1               8               8       
810.12(b)                               1               1               1               8               8       
810.14                                  2               1               2              16              32       
810.15                                  2               1               2              16              32       
810.16                                  2              12              24              40             960       
810.17                                  2               1               2               8              16       
Total                                                                                               1,072       
----------------------------------------------------------------------------------------------------------------
There are no capital costs or operating and maintenance costs associated with this collection.                  

List of Subjects in 21 CFR Part 810

    Administrative practice and procedure, Cease distribution and 
notification orders, Mandatory recall orders, Medical devices, 
Recordkeeping and reporting requirements.
    Therefore, under the Federal Food, Drug, and Cosmetic Act, and 
under authority delegated to the Commissioner of Food and Drugs, new 
part 810 is added to read as follows:

PART 810--MEDICAL DEVICE RECALL AUTHORITY

Subpart A--General Provisions

Sec.
810.1  Scope.
810.2  Definitions.
810.3  Computation of time.
810.4  Service of orders.

Subpart B--Mandatory Medical Device Recall Procedures

810.10  Cease distribution and notification order.
810.11  Regulatory hearing.
810.12  Written request for review of cease distribution and 
notification order.
810.13  Mandatory recall order.
810.14  Cease distribution and notification or mandatory recall 
strategy.
810.15  Communications concerning a cease distribution and 
notification or mandatory recall order.
    810.16  Cease distribution and notification or mandatory recall 
order status reports.
    810.17  Termination of a cease distribution and notification or 
mandatory recall order.
810.18  Public notice.
    Authority: Secs. 201, 301, 302, 303, 304, 501, 502, 518, 701, 
704, 705 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321, 
331, 332, 333, 334, 351, 352, 360h, 371, 374, 375).

Subpart A--General Provisions


Sec. 810.1  Scope.

    Part 810 describes the procedures that the Food and Drug 
Administration will follow in exercising its medical device recall 
authority under section 518(e) of the Federal Food, Drug, and Cosmetic 
Act.

[[Page 59019]]

Sec. 810.2  Definitions.

    As used in this part:
    (a) Act means the Federal Food, Drug, and Cosmetic Act.
    (b) Agency or FDA means the Food and Drug Administration.
    (c) Cease distribution and notification strategy or mandatory 
recall strategy means a planned, specific course of action to be taken 
by the person named in a cease distribution and notification order or 
in a mandatory recall order, which addresses the extent of the 
notification or recall, the need for public warnings, and the extent of 
effectiveness checks to be conducted.
    (d) Consignee means any person or firm that has received, 
purchased, or used a device that is subject to a cease distribution and 
notification order or a mandatory recall order. Consignee does not mean 
lay individuals or patients, i.e., nonhealth professionals.
    (e) Correction means repair, modification, adjustment, relabeling, 
destruction, or inspection (including patient monitoring) of a device, 
without its physical removal from its point of use to some other 
location.
    (f) Device user facility means a hospital, ambulatory surgical 
facility, nursing home, or outpatient treatment or diagnostic facility 
that is not a physician's office.
    (g) Health professionals means practitioners, including physicians, 
nurses, pharmacists, dentists, respiratory therapists, physical 
therapists, technologists, or any other practitioners or allied health 
professionals that have a role in using a device for human use.
    (h) Reasonable probability means that it is more likely than not 
that an event will occur.
    (i) Serious, adverse health consequence means any significant 
adverse experience, including those that may be either life-threatening 
or involve permanent or long-term injuries, but excluding injuries that 
are nonlife-threatening and that are temporary and reasonably 
reversible.
    (j) Recall means the correction or removal of a device for human 
use where FDA finds that there is a reasonable probability that the 
device would cause serious, adverse health consequences or death.
    (k) Removal means the physical removal of a device from its point 
of use to some other location for repair, modification, adjustment, 
relabeling, destruction, or inspection.


Sec. 810.3  Computation of time.

    In computing any period of time prescribed or allowed by this part, 
the day of the act or event from which the designated period of time 
begins to run shall not be included. The computation of time is based 
only on working days.


Sec. 810.4  Service of orders.

    Orders issued under this part will be served in person by a 
designated employee of FDA, or by certified or registered mail or 
similar mail delivery service with a return receipt record reflecting 
receipt, to the named person or designated agent at the named person's 
or designated agent's last known address in FDA's records.

Subpart B--Mandatory Medical Device Recall Procedures


Sec. 810.10  Cease distribution and notification order.

    (a) If, after providing the appropriate person with an opportunity 
to consult with the agency, FDA finds that there is a reasonable 
probability that a device intended for human use would cause serious, 
adverse health consequences or death, the agency may issue a cease 
distribution and notification order requiring the person named in the 
order to immediately:
    (1) Cease distribution of the device;
    (2) Notify health professionals and device user facilities of the 
order; and
    (3) Instruct these professionals and device user facilities to 
cease use of the device.
    (b) FDA will include the following information in the order:
    (1) The requirements of the order relating to cessation of 
distribution and notification of health professionals and device user 
facilities;
    (2) Pertinent descriptive information to enable accurate and 
immediate identification of the device subject to the order, including, 
where known:
    (i) The brand name of the device;
    (ii) The common name, classification name, or usual name of the 
device;
    (iii) The model, catalog, or product code numbers of the device; 
and
    (iv) The manufacturing lot numbers or serial numbers of the device 
or other identification numbers; and
    (3) A statement of the grounds for FDA's finding that there is a 
reasonable probability that the device would cause serious, adverse 
health consequences or death.
    (c) FDA may also include in the order a model letter for notifying 
health professionals and device user facilities of the order and a 
requirement that notification of health professionals and device user 
facilities be completed within a specified timeframe. The model letter 
will include the key elements of information that the agency in its 
discretion has determined, based on the circumstances surrounding the 
issuance of each order, are necessary to inform health professionals 
and device user facilities about the order.
    (d) FDA may also require that the person named in the cease 
distribution and notification order submit any or all of the following 
information to the agency by a time specified in the order:
    (1) The total number of units of the device produced and the 
timespan of the production;
    (2) The total number of units of the device estimated to be in 
distribution channels;
    (3) The total number of units of the device estimated to be 
distributed to health professionals and device user facilities;
    (4) The total number of units of the device estimated to be in the 
hands of home users;
    (5) Distribution information, including the names and addresses of 
all consignees;
    (6) A copy of any written communication used by the person named in 
the order to notify health professionals and device user facilities;
    (7) A proposed strategy for complying with the cease distribution 
and notification order;
    (8) Progress reports to be made at specified intervals, showing the 
names and addresses of health professionals and device user facilities 
that have been notified, names of specific individuals contacted within 
device user facilities, and the dates of such contacts; and
    (9) The name, address, and telephone number of the person who 
should be contacted concerning implementation of the order.
    (e) FDA will provide the person named in a cease distribution and 
notification order with an opportunity for a regulatory hearing on the 
actions required by the cease distribution and notification order and 
on whether the order should be modified, or vacated, or amended to 
require a mandatory recall of the device.
    (f) FDA will also provide the person named in the cease 
distribution and notification order with an opportunity, in lieu of a 
regulatory hearing, to submit a written request to FDA asking that the 
order be modified, or vacated, or amended.
    (g) FDA will include in the cease distribution and notification 
order the name, address, and telephone number of an agency employee to 
whom any request for a regulatory hearing or agency review is to be 
addressed.


Sec. 810.11  Regulatory hearing.

    (a) Any request for a regulatory hearing shall be submitted in 
writing to the agency employee identified in the

[[Page 59020]]

order within the timeframe specified by FDA. Under Sec. 16.22(b) of 
this chapter, this timeframe ordinarily will not be fewer than 3 
working days after receipt of the cease distribution and notification 
order. However, as provided in Sec. 16.60(h) of this chapter, the 
Commissioner of Food and Drugs or presiding officer may waive, suspend, 
or modify any provision of part 16 under Sec. 10.19 of this chapter, 
including those pertaining to the timing of the hearing. As provided in 
Sec. 16.26(a), the Commissioner or presiding officer may deny a request 
for a hearing, in whole or in part, if he or she determines that no 
genuine and substantial issue of fact is raised by the material 
submitted in the request.
    (b) If a request for a regulatory hearing is granted, the 
regulatory hearing shall be limited to:
    (1) Reviewing the actions required by the cease distribution and 
notification order, determining if FDA should affirm, modify, or vacate 
the order, and addressing an appropriate cease distribution and 
notification strategy; and
    (2) Determining whether FDA should amend the cease distribution and 
notification order to require a recall of the device that was the 
subject of the order. The hearing may also address the actions that 
might be required by a recall order, including an appropriate recall 
strategy, if FDA later orders a recall.
    (c) If a request by the person named in a cease distribution and 
notification order for a regulatory hearing is granted, the regulatory 
hearing will be conducted in accordance with the procedures set out in 
section 201(x) of the act (21 U.S.C. 321(x)) and part 16 of this 
chapter, except that the order issued under Sec. 810.10, rather than a 
notice under Sec. 16.22(a) of this chapter, provides the notice of 
opportunity for a hearing and is part of the administrative record of 
the regulatory hearing under Sec. 16.80(a) of this chapter. As provided 
in Sec. 16.60(h) of this chapter, the Commissioner of Food and Drugs or 
presiding officer may waive, suspend, or modify any provision of part 
16 under Sec. 10.19 of this chapter. As provided in Sec. 16.26(b), 
after the hearing commences, the presiding officer may issue a summary 
decision on any issue if the presiding officer determines that there is 
no genuine and substantial issue of fact respecting that issue.
    (d) If the person named in the cease distribution and notification 
order does not request a regulatory hearing within the timeframe 
specified by FDA in the cease distribution and notification order, that 
person will be deemed to have waived his or her right to request a 
hearing.
    (e) The presiding officer will ordinarily hold any regulatory 
hearing requested under paragraph (a) of this section no fewer than 2 
working days after receipt of the request for a hearing, under 
Sec. 16.24(e) of this chapter, and no later than 10 working days after 
the date of issuance of the cease distribution and notification order. 
However, FDA and the person named in the order may agree to a later 
date or the presiding officer may determine that the hearing should be 
held in fewer than 2 days. Moreover, as provided for in Sec. 16.60(h) 
of this chapter, the Commissioner of Food and Drugs or presiding 
officer may waive, suspend, or modify any provision of part 16 under 
Sec. 10.19 of this chapter, including those pertaining to the timing of 
the hearing. After the presiding officer prepares a written report of 
the hearing and the agency issues a final decision based on the report, 
the presiding officer shall provide the requestor written notification 
of the final decision to affirm, modify, or vacate the order or to 
amend the order to require a recall of the device within 15 working 
days of conducting a regulatory hearing.


Sec. 810.12  Written request for review of cease distribution and 
notification order.

    (a) In lieu of requesting a regulatory hearing under Sec. 810.11, 
the person named in a cease distribution and notification order may 
submit a written request to FDA asking that the order be modified or 
vacated. Such person shall address the written request to the agency 
employee identified in the order and shall submit the request within 
the timeframe specified in the order, unless FDA and the person named 
in the order agree to a later date.
    (b) A written request for review of a cease distribution and 
notification order shall identify each ground upon which the requestor 
relies in asking that the order be modified or vacated, as well as 
addressing an appropriate cease distribution and notification strategy, 
and shall address whether the order should be amended to require a 
recall of the device that was the subject of the order and the actions 
required by such a recall order, including an appropriate recall 
strategy.
    (c) The agency official who issued the cease distribution and 
notification order shall provide the requestor written notification of 
the agency's decision to affirm, modify, or vacate the order or amend 
the order to require a recall of the device within 15 working days of 
receipt of the written request. The agency official shall include in 
this written notification:
    (1) A statement of the grounds for the decision to affirm, modify, 
vacate, or amend the order; and
    (2) The requirements of any modified or amended order.


Sec. 810.13  Mandatory recall order.

    (a) If the person named in a cease distribution and notification 
order does not request a regulatory hearing or submit a request for 
agency review of the order, or, if the Commissioner of Food and Drugs 
or the presiding officer denies a request for a hearing, or, if after 
conducting a regulatory hearing under Sec. 810.11 or completing agency 
review of a cease distribution and notification order under 
Sec. 810.12, FDA determines that the order should be amended to require 
a recall of the device with respect to which the order was issued, FDA 
shall amend the order to require such a recall. FDA shall amend the 
order to require such a recall within 15 working days of issuance of a 
cease distribution and notification order if a regulatory hearing or 
agency review of the order is not requested, or within 15 working days 
of denying a request for a hearing, or within 15 working days of 
completing a regulatory hearing under Sec. 810.11, or within 15 working 
days of receipt of a written request for review of a cease distribution 
and notification order under Sec. 810.12.
    (b) In a mandatory recall order, FDA may:
    (1) Specify that the recall is to extend to the wholesale, retail, 
or user level;
    (2) Specify a timetable in accordance with which the recall is to 
begin and be completed;
    (3) Require the person named in the order to submit to the agency a 
proposed recall strategy, as described in Sec. 810.14, and periodic 
reports describing the progress of the mandatory recall, as described 
in Sec. 810.16; and
    (4) Provide the person named in the order with a model recall 
notification letter that includes the key elements of information that 
FDA has determined are necessary to inform health professionals and 
device user facilities.
    (c) FDA will not include in a mandatory recall order a requirement 
for:
    (1) Recall of a device from individuals; or
    (2) Recall of a device from device user facilities, if FDA 
determines that the risk of recalling the device from the facilities 
presents a greater health risk than the health risk of not recalling 
the device from use, unless the device can

[[Page 59021]]

be replaced immediately with an equivalent device.
    (d) FDA will include in a mandatory recall order provisions for 
notification to individuals subject to the risks associated with use of 
the device. If a significant number of such individuals cannot be 
identified, FDA may notify such individuals under section 705(b) of the 
act.


Sec. 810.14  Cease distribution and notification or mandatory recall 
strategy.

    (a) General. The person named in a cease distribution and 
notification order issued under Sec. 810.10 shall comply with the 
order, which FDA will fashion as appropriate for the individual 
circumstances of the case. The person named in a cease distribution and 
notification order modified under Sec. 810.11(e) or Sec. 810.12(c) or a 
mandatory recall order issued under Sec. 810.13 shall develop a 
strategy for complying with the order that is appropriate for the 
individual circumstances and that takes into account the following 
factors:
    (1) The nature of the serious, adverse health consequences related 
to the device;
    (2) The ease of identifying the device;
    (3) The extent to which the risk presented by the device is obvious 
to a health professional or device user facility; and
    (4) The extent to which the device is used by health professionals 
and device user facilities.
    (b) Submission and review. (1) The person named in the cease 
distribution and notification order modified under Sec. 810.11(e) or 
Sec. 810.12(c) or mandatory recall order shall submit a copy of the 
proposed strategy to the agency within the timeframe specified in the 
order.
    (2) The agency will review the proposed strategy and make any 
changes to the strategy that it deems necessary within 7 working days 
of receipt of the proposed strategy. The person named in the order 
shall act in accordance with a strategy determined by FDA to be 
appropriate.
    (c) Elements of the strategy. A proposed strategy shall meet all of 
the following requirements:
    (1)(i) The person named in the order shall specify the level in the 
chain of distribution to which the cease distribution and notification 
order or mandatory recall order is to extend as follows:
    (A) Consumer or user level, e.g., health professionals, consignee, 
or device user facility level, including any intermediate wholesale or 
retail level; or
    (B) Retail level, to the level immediately preceding the consumer 
or user level, and including any intermediate level; or
    (C) Wholesale level.
    (ii) The person named in the order shall not recall a device from 
individuals; and
    (iii) The person named in the order shall not recall a device from 
device user facilities if FDA notifies the person not to do so because 
of a risk determination under Sec. 810.13(c)(2).
    (2) The person named in a recall order shall ensure that the 
strategy provides for notice to individuals subject to the risks 
associated with use of the recalled device. The notice may be provided 
through the individuals' health professionals if FDA determines that 
such consultation is appropriate and would be the most effective method 
of notifying patients.
    (3) Effectiveness checks by the person named in the order are 
required to verify that all health professionals, device user 
facilities, consignees, and individuals, as appropriate, have been 
notified of the cease distribution and notification order or mandatory 
recall order and of the need to take appropriate action. The person 
named in the cease distribution and notification order or the mandatory 
recall order shall specify in the strategy the method(s) to be used in 
addition to written communications as required by Sec. 810.15, i.e., 
personal visits, telephone calls, or a combination thereof to contact 
all health professionals, device user facilities, consignees, and 
individuals, as appropriate. The agency may conduct additional audit 
checks where appropriate.


Sec. 810.15  Communications concerning a cease distribution and 
notification or mandatory recall order.

    (a) General. The person named in a cease distribution and 
notification order issued under Sec. 810.10 or a mandatory recall order 
issued under Sec. 810.13 is responsible for promptly notifying each 
health professional, device user facility, consignee, or individual, as 
appropriate, of the order. In accordance with Sec. 810.10(c) or 
Sec. 810.13(b)(4), FDA may provide the person named in the cease 
distribution and notification or mandatory recall order with a model 
letter for notifying each health professional, device user facility, 
consignee, or individual, as appropriate, of the order. However, if FDA 
does not provide the person named in the cease distribution and 
notification or mandatory recall order with a model letter, the person 
named in a cease distribution and notification order issued under 
Sec. 810.10, or a mandatory recall order issued under Sec. 810.13, is 
responsible for providing such notification. The purpose of the 
communication is to convey:
    (1) That FDA has found that there is a reasonable probability that 
use of the device would cause a serious, adverse health consequence or 
death;
    (2) That the person named in the order has ceased distribution of 
the device;
    (3) That health professionals and device user facilities should 
cease use of the device immediately;
    (4) Where appropriate, that the device is subject to a mandatory 
recall order; and
    (5) Specific instructions on what should be done with the device.
    (b) Implementation. The person named in a cease distribution and 
notification order, or a mandatory recall order, shall notify the 
appropriate person(s) of the order by verified written communication, 
e.g., telegram, mailgram, or fax. The written communication and any 
envelope in which it is sent or enclosed shall be conspicuously marked, 
preferably in bold red ink: ``URGENT--[DEVICE CEASE DISTRIBUTION AND 
NOTIFICATION ORDER] or [MANDATORY DEVICE RECALL ORDER].'' Telephone 
calls or other personal contacts may be made in addition to, but not as 
a substitute for, the verified written communication, and shall be 
documented in an appropriate manner.
    (c) Contents. The person named in the order shall ensure that the 
notice of a cease distribution and notification order or mandatory 
recall order:
    (1) Is brief and to the point;
    (2) Identifies clearly the device, size, lot number(s), code(s), or 
serial number(s), and any other pertinent descriptive information to 
facilitate accurate and immediate identification of the device;
    (3) Explains concisely the serious, adverse health consequences 
that may occur if use of the device were continued;
    (4) Provides specific instructions on what should be done with the 
device;
    (5) Provides a ready means for the recipient of the communication 
to confirm receipt of the communication and to notify the person named 
in the order of the actions taken in response to the communication. 
Such means may include, but are not limited to, the return of a 
postage-paid, self-addressed post card or a toll-free call to the 
person named in the order; and
    (6) Does not contain irrelevant qualifications, promotional 
materials, or any other statement that may detract from the message.

[[Page 59022]]

    (d) Followup communications. The person named in the cease 
distribution and notification order or mandatory recall order shall 
ensure that followup communications are sent to all who fail to respond 
to the initial communication.
    (e) Responsibility of the recipient. Health professionals, device 
user facilities, and consignees who receive a communication concerning 
a cease distribution and notification order or a mandatory recall order 
should immediately follow the instructions set forth in the 
communication. Where appropriate, these recipients should immediately 
notify their consignees of the order in accordance with paragraphs (b) 
and (c) of this section.


Sec. 810.16  Cease distribution and notification or mandatory recall 
order status reports.

    (a) The person named in a cease distribution and notification order 
issued under Sec. 810.10 or a mandatory recall order issued under 
Sec. 810.13 shall submit periodic status reports to FDA to enable the 
agency to assess the person's progress in complying with the order. The 
frequency of such reports and the agency official to whom such reports 
shall be submitted will be specified in the order.
    (b) Unless otherwise specified in the order, each status report 
shall contain the following information:
    (1) The number and type of health professionals, device user 
facilities, consignees, or individuals notified about the order and the 
date and method of notification;
    (2) The number and type of health professionals, device user 
facilities, consignees, or individuals who have responded to the 
communication and the quantity of the device on hand at these locations 
at the time they received the communication;
    (3) The number and type of health professionals, device user 
facilities, consignees, or individuals who have not responded to the 
communication;
    (4) The number of devices returned or corrected by each health 
professional, device user facility, consignee, or individual contacted, 
and the quantity of products accounted for;
    (5) The number and results of effectiveness checks that have been 
made; and
    (6) Estimated timeframes for completion of the requirements of the 
cease distribution and notification order or mandatory recall order.
    (c) The person named in the cease distribution and notification 
order or recall order may discontinue the submission of status reports 
when the agency terminates the order in accordance with Sec. 810.17.


Sec. 810.17  Termination of a cease distribution and notification or 
mandatory recall order.

    (a) The person named in a cease distribution and notification order 
issued under Sec. 810.10 or a mandatory recall order issued under 
Sec. 810.13 may request termination of the order by submitting a 
written request to FDA. The person submitting a request shall certify 
that he or she has complied in full with all of the requirements of the 
order and shall include a copy of the most current status report 
submitted to the agency under Sec. 810.16. A request for termination of 
a recall order shall include a description of the disposition of the 
recalled device.
    (b) FDA may terminate a cease distribution and notification order 
issued under Sec. 810.10 or a mandatory recall order issued under 
Sec. 810.13 when the agency determines that the person named in the 
order:
    (1) Has taken all reasonable efforts to ensure and to verify that 
all health professionals, device user facilities, consignees, and, 
where appropriate, individuals have been notified of the cease 
distribution and notification order, and to verify that they have been 
instructed to cease use of the device and to take other appropriate 
action; or
    (2) Has removed the device from the market or has corrected the 
device so that use of the device would not cause serious, adverse 
health consequences or death.
    (c) FDA will provide written notification to the person named in 
the order when a request for termination of a cease distribution and 
notification order or a mandatory recall order has been granted or 
denied. FDA will respond to a written request for termination of a 
cease distribution and notification or recall order within 30 working 
days of its receipt.


Sec. 810.18  Public notice.

    The agency will make available to the public in the weekly FDA 
Enforcement Report a descriptive listing of each new mandatory recall 
issued under Sec. 810.13. The agency will delay public notification of 
orders when the agency determines that such notification may cause 
unnecessary and harmful anxiety in individuals and that initial 
consultation between individuals and their health professionals is 
essential.

    Dated: November 8, 1996.
William B. Schultz,
Deputy Commissioner for Policy.
[FR Doc. 96-29695 Filed 11-19-96; 8:45 am]
BILLING CODE 4160-01-F