[Federal Register Volume 59, Number 113 (Tuesday, June 14, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-14444]


[[Page Unknown]]

[Federal Register: June 14, 1994]


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Part V





Department of Health and Human Services





_______________________________________________________________________



Food and Drug Administration



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21 CFR Part 810




Medical Device Recall Authority; Proposed Rule
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

21 CFR Part 810
[Docket No. 93N-0260]
 
Medical Device Recall Authority
AGENCY: Food and Drug Administration, HHS.

ACTION: Proposed rule.

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SUMMARY:  The Food and Drug Administration (FDA) is publishing a 
proposed regulation to establish procedures to implement the new 
medical device recall authority provided in the Safe Medical Devices 
Act of 1990 (the SMDA). This new statutory authority protects the 
public health by permitting FDA to remove dangerous devices from the 
market promptly. This authority adds to other remedies already 
available to the agency, including notification, repair, replacement, 
and refund.

DATES: Written comments by September 12, 1994. FDA intends that any 
final rule that may issue based on this proposal become effective July 
14, 1994.

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

FOR FURTHER INFORMATION CONTACT: John H. Samalik, Center for Devices 
and Radiological Health (HFZ-321), Food and Drug Administration, 2098 
Gaither Rd., Rockville, MD 20850, 301-594-4595.

SUPPLEMENTARY INFORMATION: 
I. Background and Legislative History
    On November 28, 1990, the SMDA, which amended the Federal Food, 
Drug, and Cosmetic Act (the act) (21 U.S.C. 301 et seq.), became law. 
The purpose of the new law was to improve the Medical Device Amendments 
of 1976 (Pub. L. 94-295) (the 1976 amendments), which had amended the 
act by establishing a comprehensive framework to regulate medical 
devices intended for human use in order to ensure their safety and 
effectiveness. The SMDA includes provisions designed to expand and 
strengthen FDA's authority to ensure that devices entering the market 
are safe and effective, to learn quickly about serious problems 
associated with medical devices, and to remove dangerous and defective 
devices from the market promptly.
    The 1976 amendments provided FDA with various premarket controls 
over medical devices (e.g., classification, premarket notification, and 
premarket approval). The 1976 amendments also broadened the postmarket 
controls available to FDA with respect to medical devices, giving FDA 
the authority to require patient notification, repair, replacement or 
refund; medical device reporting and recordkeeping; compliance with 
current good manufacturing practices; and restrictions on the 
distribution of certain devices.
    In 1990, Congress concluded, based on hearings and investigations, 
that the regulatory scheme established in the 1976 amendments was 
inadequate to protect the public health (H. Rept. 808, 101st Cong., 2d 
sess. 13-14 (1990)). The SMDA was enacted to enhance that regulatory 
scheme. Thus, the legislative intent of the SMDA in general was to 
streamline and strengthen the premarket and postmarket controls 
available to FDA with respect to medical devices.
    In drafting the SMDA, both the House of Representatives and the 
Senate focused considerable attention on the implementation and 
enforcement of section 518 of the act (21 U.S.C. 360h) since its 
enactment in the 1976 amendments. This section, added by the 1976 
amendments and amended by the Medical Device Amendments of 1992 (Pub. 
L. 102-300), 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 remedies provided in 
sections 518(a), (b), and (c) of the act are available where the agency 
has determined that the device presents an unreasonable risk of 
substantial harm to the public health.
    The House Report accompanying H.R. 3095 states that:

    [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).
    Section 8 of the SMDA amended section 518 of the act by adding a 
new subsection (e) entitled ``Recall Authority.'' 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.
    Congress explained that ``a `reasonable probability' of an event is 
where it is more likely than not that the event will occur,'' and that 
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.'' (S. Rept. 513, 
101st Cong., 2d sess. 19 (1990)).
    The legislative history also makes clear that the term ``serious, 
adverse health consequences'' is intended to mean:

    Any significant adverse experience attributable to a device, 
including those which may be either life threatening, or involving 
permanent or long-term injuries, but excluding those non-life-
threatening injuries which are temporary and reasonably reversible. 
In other words, injuries attributable to a device that are not 
significant in nature and are treatable and reversible by standard 
medical techniques, proximate in time to the injury, are not 
included within the term's definition.

    Section 518(e) of the act is self-executing and does not require 
rulemaking before the authority granted may be exercised. FDA is 
issuing this proposed rule, however, pursuant to its authority to 
promulgate regulations under section 701(a) of the act (21 U.S.C. 
371(a)), to establish publicly the procedures that will be followed 
when FDA exercises its recall authority. FDA has already found the new 
authority in section 518(e) of the act useful in securing the prompt 
removal from the market of several devices that presented a risk to the 
public health under the statutory standard. The experience gained to 
date has been useful to the agency in developing the proposed rule.
II. Statutory Requirements
    Section 518(e) of the act sets out a three-step procedure for the 
issuance of a mandatory medical device recall order. First, after 
finding that there is a reasonable probability that a device intended 
for human use would cause serious, adverse health consequences or 
death, FDA may issue a cease distribution and notification order 
requiring the appropriate person 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 
facilities to cease use of the device.
    Second, FDA will provide the person named in the cease distribution 
and notification order with the opportunity for an informal hearing on 
whether the order should be modified, vacated, or amended to require a 
mandatory recall of the device.
    Third, after providing the opportunity for an informal hearing, FDA 
may issue a mandatory recall order if the agency determines that such 
an order is necessary.
    As stated above, FDA will provide the person named in a cease 
distribution and notification order with an opportunity for an informal 
hearing. The hearing is to be held not later than 10 days after the 
date of issuance of the order. If a hearing is requested, the device 
still may not be distributed and health professionals and device user 
facilities must still be notified.
    The language of the statute makes clear that there is to be only 
one opportunity for a hearing, and that the purposes of any hearing 
that is held are both to address the actions required by the cease 
distribution and notification order and to determine whether the order 
should be amended to require a recall. The legislative history of 
section 518(e) of the act, as reflected in the conference report, also 
clearly demonstrates congressional intent that there be one, and only 
one, opportunity for a hearing following the cease distribution order, 
and that it is at this hearing that the person named in the order may 
present data and information showing why the order should not be 
amended to require a recall:
    The conference agreement requires [FDA], after making an 
appropriate finding, to issue an initial order providing for the 
immediate cessation of distribution 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. 
[Emphasis added.]
(Conf. Rept. 959, 101st Cong., 2d sess. 25 (1990).
    Congress intended that the informal hearing ``would be analogous to 
the judicial hearing that is held prior to granting a temporary 
restraining order. Where circumstances require expedited action, a 
motion for a temporary restraining order can result in notice, a 
hearing and a judicial decision in a single day.'' (H. Rept. 808, 101st 
Cong., 2d sess. 29 (1990)).

III. Scope of the Proposed Regulation

    The proposed regulation implementing section 518(e) of the act, if 
made final, would be set out in new 21 CFR Part 810--Medical Device 
Recall Authority. The regulation would establish the procedures that 
FDA would follow in conducting medical device recalls under section 
518(e) of the act. FDA believes that the proposed regulation realizes 
congressional intent to allow for prompt action by the agency to 
protect the public health, while ensuring the rights of persons subject 
to a cease distribution and notification order or mandatory recall 
order. (S. Rept. 513, 101st Cong., 2d sess. 20 (1990)).

IV. Definition of Terms, Computing of Time, and Service of Orders

    Proposed Sec. 810.2 defines certain terms used in the proposed 
regulation. To ensure consistency in application, to the extent 
practicable, the proposed definitions of these terms are similar to 
definitions used in FDA's recall guidelines (part 7, subpart C (21 CFR 
part 7, subpart C)) or in proposed regulations to implement other 
provisions of the SMDA. Thus, the definitions of ``cease distribution 
and notification strategy,'' ``mandatory recall strategy,'' 
``consignee,'' and ``correction,'' are based on definitions in 
Sec. 7.3. The definition of ``device user facility'' is the same as 
that used in the medical device reporting tentative final rule (56 FR 
60024, November 26, 1991).
    The definitions of ``reasonable probability'' and ``serious, 
adverse health consequences'' are consistent with congressional use of 
these terms in the legislative history. (S. Rept. 513, 101st Cong., 2d 
sess. 19 (1990)).
    Proposed Sec. 810.3 provides that, in computing any period of time 
prescribed or allowed by the proposed regulation, the following rules 
would apply. First, the day of the act or event from which the 
designated period of time begins to run would not be included: ``Day 
1'' would be the day after the act or event. Second, all calendar days 
would be included in the computation, including the last day of the 
period, unless the last day is a Saturday, Sunday, or Federal legal 
holiday, or, when the act to be done is the filing of a document with 
the agency, a day on which weather or other conditions have made the 
agency office to which such a filing is to be made inaccessible. In 
those cases, the period would run until the end of the next day which 
is not one of the days described above. For example, if a person named 
in a cease distribution and notification order receives the order on 
Friday, November 1, and a request for an informal hearing is required 
to be submitted to FDA within 3 days, the request would need to be 
submitted to FDA by the close of business on Monday, November 4. If the 
FDA office to which the request is to be submitted were closed on 
Monday, November 4, because of weather conditions, the request would be 
required to be submitted by close of business on Tuesday, November 5, 
or the next day on which the FDA office was open for business.

V. Procedures

    Proposed Sec. 810.10(d) describes certain information that FDA may 
require the person named in a cease distribution and notification order 
to submit to the agency. This information is similar to the information 
that firms which initiate voluntary recalls are now asked to submit to 
FDA under Sec. 7.46. The reason for requiring submission of this 
information is to enable FDA to monitor compliance with the cease 
distribution and notification order and to determine whether additional 
action is necessary.
    Under section 518(e)(1), FDA will provide the person named in a 
cease distribution and notification order with an opportunity for an 
informal hearing, to be held not later than 10 days after the date of 
issuance of the order, on the actions required by the order and on 
whether the order should be amended to require a recall. The term 
``informal hearing'' is defined in section 201(y) of the act (21 U.S.C. 
321(y)). In the Federal Register of August 20, 1976 (41 FR 35282 at 
35289), FDA interpreted the ``informal hearing'' provisions of section 
201(y) of the act as the ``functional equivalent of FDA's regulatory 
hearing'' described in 21 CFR part 16.
    Proposed Sec. 810.11(a)(1) provides that the person named in a 
cease distribution and notification order may, within the timeframe 
specified in the order, submit a written request to FDA for a 
regulatory hearing. The request must be addressed to the agency 
employee identified in the order. Ordinarily, FDA will require that the 
person named in the cease distribution and notification order submit 
the hearing request within 3 days of receipt of the order. Where 
warranted, however, 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. These procedures reflect congressional 
intent that the hearing be analogous to a hearing on a temporary 
restraining order, where notice, a hearing, and a judicial decision may 
all occur in a single day. (H. Rept. 808, 101st Cong., 2d sess. 29 
(1990)).
    Under 21 CFR 16.26(b), after the hearing commences, the presiding 
officer may issue a summary decision on any issue in the hearing if he 
or she determines that there is no genuine and substantial issue of 
fact respecting that issue.
    Although not required by section 518(e) of the act, FDA is 
proposing an alternative review process for persons who do not want to 
make an appearance before the agency, but who do wish to challenge a 
cease distribution and notification order. Accordingly, under proposed 
Sec. 810.12(a), the person named in a cease distribution and 
notification order may, in lieu of requesting a regulatory hearing 
under proposed Sec. 810.11, submit a written request to FDA asking that 
the order be modified or vacated. The written request must be addressed 
to the agency employee identified in the order and must be submitted 
within the timeframe specified in the order.
    FDA recognizes that, in the time immediately following the issuance 
of a cease distribution and notification order, sufficient information 
may not be available to the agency to enable it to determine whether 
the actions being taken by the person named in the order are adequate 
to protect the public health. For example, where the person named in 
the order elects to recall the device voluntarily, it is possible that 
FDA may determine later that the voluntary recall is inadequate to 
protect individuals from the risks associated with use of the device. 
Thus, FDA may find it necessary to amend the cease distribution and 
notification order to include a mandatory recall even where, at an 
earlier time, voluntary efforts appeared to be adequate.
    If FDA initially determines that a cease distribution and 
notification order need not be amended to require a mandatory recall, 
but subsequently finds that the person named in the order has failed to 
comply with the requirements of the order, FDA may amend the order by 
issuing a mandatory recall order under proposed Sec. 810.13.

VI. Enforcement Provisions

    The failure to comply with a cease distribution and notification 
order issued under proposed Sec. 810.10 or a mandatory recall order 
issued under proposed Sec. 810.13 renders a device misbranded under 
section 502(t)(1) of the act (21 U.S.C. 352(t)(1)). A misbranded device 
is subject to seizure under section 304 of the act (21 U.S.C. 334) and 
its introduction into interstate commerce is a prohibited act under 
sections 301(a), (b), (c), (g), and (k) of the act (21 U.S.C. 331(a), 
(b), (c), (g), (k)). Any person who fails or refuses to comply with any 
requirement of a cease distribution and notification order or a 
mandatory recall order has committed a prohibited act under section 
301(q) of the act.
    A firm in violation of section 301 of the act may be enjoined under 
section 302 of the act (21 U.S.C. 332) and any person responsible for 
the violation is subject to criminal penalties under section 303(a) of 
the act (21 U.S.C. 333(a)). In addition, any person who violates a 
requirement of the act with respect to a device is also subject to 
civil penalties under section 303(f) of the act.

VII. Environmental Impact

    The agency has determined under 21 CFR 25.24(a)(8) and (e)(4) 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.

VIII. Analysis of Impacts

    FDA has examined the impacts of the proposed rule under Executive 
Order 12866 and the Regulatory Flexibility Act (Pub. L. 96-354). 
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 proposed rule is consistent with the regulatory philosophy and 
principles identified in the Executive Order. In addition, the proposed 
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. The agency believes that only a small number of 
firms will be affected by this proposal. The recall authority would be 
invoked by the Center for Devices and Radiological Health (CDRH) in 
those instances that match very closely the definition of a 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. 
Thus, the agency believes that this new authority will not be used 
frequently. While both the number of class I recalls per year, and the 
costs associated with those recalls vary quite widely, the greatest 
number of such recalls in 1 year to date has been 36, and the average 
over the last 5 fiscal years has been 19 per year. Thus, the agency 
expects that no more than one or two recalls per year would be ordered 
that would not have occurred without this regulation. Although the 
agency does not have a cost figure for a recall, it is likely that the 
cost would be under $2 million. Because of these reasons, the agency 
certifies that the proposed 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.
    An assessment of the economic impact of any final rule based on 
this proposal has been placed on file in the Dockets Management Branch 
(address above) and may be seen by interested persons between 9 a.m. 
and 4 p.m., Monday through Friday.

IX. Paperwork Reduction Act of 1980

    This proposed rule contains information collections which are 
subject to review by the Office of Management and Budget (OMB) under 
the Paperwork Reduction Act of 1980 (44 U.S.C. Ch. 35). The title, 
description, and respondent description of the information collection 
are shown below with an estimate of the annual reporting and 
recordkeeping burden. Included in the estimate is the time for 
reviewing instructions, searching existing data sources, gathering and 
maintaining the data needed, and completing and reviewing the 
collection of information.
    Title: ``Recall Authority'' is intended to protect the public 
health by permitting FDA to ensure the prompt removal of dangerous and 
defective devices from the market under Pub. L. 101-629.
    Description: FDA is publishing a proposed regulation to establish 
procedures to implement the new medical device recall authority 
provided in the SMDA of 1990. In accordance with that authority, FDA 
may issue an order requiring appropriate persons to cease distribution 
of a medical device and to notify health professionals and device user 
facilities of the order and instruct them to cease use of the device, 
if the agency finds that there is a reasonable probability that the 
device would cause serious adverse health consequences or death. After 
providing the person subject to the order with an opportunity for an 
informal hearing, FDA may amend the order to require a mandatory recall 
of the device. This authority is in addition to other remedies already 
available to the agency, including notification, repair, replacement, 
refund, and reimbursement. 

                                                            Estimated Annual Reporting Burden                                                           
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                 Section                       Annual Number of Responses       Average Burden Per Response (hours)      Total Annual Burden (hours)    
--------------------------------------------------------------------------------------------------------------------------------------------------------
Sec. 810.13(b)(3)                                                           2                                  480                                  960 
--------------------------------------------------------------------------------------------------------------------------------------------------------

    As required by section 3504(h) of the Paperwork Reduction Act of 
1980, FDA has submitted a copy of this proposed rule to OMB for its 
review of these information collection requirements. Other 
organizations and individuals wishing to submit comments regarding this 
burden estimate or any aspects of these information collection 
requirements, including suggestions for reducing the burden, should 
direct comments to FDA's Dockets Management Branch (address above) and 
to the Office of Information and Regulatory Affairs, OMB, rm. 3208, New 
Executive Office Bldg., Washington, D.C. 20503, Attn: Desk Officer for 
FDA.

X. Request for Comments

    Interested persons may, on or before September 12, 1994, submit to 
the Dockets Management Branch (address above) written comments 
regarding this proposal. Two copies of any comments are to be 
submitted, except that individuals may submit one copy. Comments are to 
be identified with the docket number found in brackets in the heading 
of this document. Received comments may be seen in the office above 
between 9 a.m. and 4 p.m., Monday through Friday.

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, it is 
proposed that new part 810 be 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, 
705 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321, 331, 
332, 333, 334, 351, 352, 360h, 371, 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.


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.
    (e)  Correction means repair, modification, adjustment, relabeling, 
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 which may be either life 
threatening or involve permanent or long-range injuries, but excluding 
non-life-threatening injuries that are temporary and reasonably 
reversible. 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.
    (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 last day of the period shall 
be included unless it is a Saturday, Sunday, or Federal legal holiday, 
or, when the act to be done is the filing of a document with the 
agency, a day on which weather or other conditions have made the agency 
office to which such a filing is to be made inaccessible, in which 
event the period runs until the end of the next day which is not one of 
the aforementioned 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 registered mail, 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 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 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.
    (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 begin and be completed within a specified timeframe.
    (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 
distributed and the timespan of the production and distribution.
    (2) The total number of units of the device estimated to be in 
distribution channels.
    (3) The total number of units of the device distributed to health 
professionals and user facilities.
    (4) The total number of units of the device in the hands of home 
users.
    (5) Distribution information, including the names and addresses of 
all direct consignees.
    (6) A copy of any written communication used by the person named in 
the order to notify health professionals and user facilities.
    (7) The 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 user facilities that 
have been notified, names of specific individuals contacted within user 
facilities, and the dates and times of such contacts.
    (9) The name and address of any health professional or user 
facility that refuses to comply with the notification instructions.
    (10) 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, 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.
    (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 order within the 
timeframe specified by FDA.
    (b) The regulatory hearing shall be limited to:
    (1) Reviewing the actions required by the cease distribution and 
notification order and determining whether FDA should affirm, modify, 
or vacate the order; 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.
    (c) Any hearing requested by the person named in a cease 
distribution and notification order will be conducted in accordance 
with the procedures set out in section 201(y) of the act (21 U.S.C. 
321(y)) and part 16 of this chapter, except that the order issued under 
Sec. 810.10, rather than a notice underSec. 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, if FDA 
believes that immediate action is necessary to protect the public 
health, the agency may waive, suspend, or modify any procedure in part 
16 pursuant to Sec. 10.19 of this chapter.
    (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 a hearing.
    (e) The presiding officer will hold any regulatory hearing 
requested under paragraph (a) of this section not later than 10 days 
after the date of issuance of the cease distribution and notification 
order, unless FDA and the person named in the order agree to a later 
date.


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

    (a) In lieu of requesting a regulatory hearing underSec. 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.
    (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.
    (c) The agency official who issued the cease distribution and 
notification order shall provide the requestor written notification of 
his or her decision to affirm, modify, or vacate the order within a 
reasonable time after completing the review of the request. The agency 
official will include in this written notification:
    (1) A statement of the grounds for the decision to affirm, modify, 
or vacate the order; and
    (2) The requirements of any modified 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 after conducting a regulatory 
hearing or completing agency review of a cease distribution and 
notification order pursuant to 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.
    (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 
occur 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.
    (4) Provide the person named in the order with a model recall 
notification letter.
    (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 be replaced immediately by 
the recalli#ng firm with an equivalent device (which may be a 
competitor's product).
    (d) FDA will include in a mandatory recall order provisions for 
notice 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 pursuant to section 705(b) 
of the act.
    (e) If FDA initially determines that a cease distribution and 
notification order need not be amended to require a mandatory recall, 
but subsequently finds that the person named in the order has failed to 
comply with the requirements of the order, or that the actions taken 
are not adequate to protect individuals from the risks associated with 
use of the device, FDA may amend the order to require a recall of the 
device.


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, 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 user facility;
    (4) The extent to which the device is used by health professionals 
and user facilities; and
    (5) The extent to which efforts to notify health professionals and 
user facilities and to instruct such professionals and facilities to 
cease use of the device have been successful.
    (6) The person named in the order shall submit a copy of the 
proposed strategy to the agency within the timeframe specified in the 
order.
    (7) The agency will review the proposed strategy and make any 
changes to the strategy it deems necessary. The person named in the 
order shall act in accordance with a strategy determined by FDA to be 
appropriate, but shall initiate the strategy as soon as submitted to 
the agency unless notified not to do so.
    (b)  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 professional, consignee, 
or 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 
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 individual's health professional if FDA determines that 
such consultation is appropriate and would be the most effective method 
of notifying patients.
    (3) Effectiveness checks by the firm are required to verify that 
all health professionals, user facilities, consignees, and individuals, 
as appropriate, have been notified of the cease distribution and 
notification order or mandatory recall order and have taken 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, i.e., personal visits, telephone calls, letters, 
or a combination thereof, and the level of the effectiveness checks 
that will be conducted, i.e., the percent of the total number of health 
professionals, user facilities, consignees, and individuals, as 
appropriate, to be contacted. The agency may conduct additional (FDA) 
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, user facility, consignee, or individual, as 
appropriate, of the order. 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 user facilities must 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 persons(s) of the order by written communication, e.g., 
telegram, mailgram, fax, or first class letter. 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 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; and
    (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.
    (6) Does not contain irrelevant qualifications, promotional 
materials, or any other statement that may detract from the message.
    (d)  Follow-up communications. The person named in the cease 
distribution and notification order or mandatory recall order shall 
ensure that follow-up communications are sent to all who fail to 
respond to the initial communication.
    (e)  Responsibility of recipient. Health professionals, user 
facilities and consignees that 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, user facilities, 
consignees, or individuals notified of the order and the date and 
method of notification;
    (2) The number and type of health professionals, user facilities, 
consignees, or individuals that have responded to the communication and 
the quantity of the device on hand at these locations at the time the 
communication was received;
    (3) The number and type of health professionals, user facilities, 
consignees, or individuals that have not responded to the 
communication;
    (4) The number of devices returned or corrected by each health 
professional, 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 time-frames for completion of the requirements of the 
cease distribution and notification order or mandatory recall order.
    (c) Submission of status reports will be discontinued when the 
agency terminates a cease distribution and notification order or recall 
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 that all health 
professionals, 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; 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 cease distribution and notification order or a 
mandatory recall order has been terminated or when a request for 
termination has been denied.


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 where 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: June 7, 1994.
Michael R. Taylor,
Deputy Commissioner for Policy.
[FR Doc. 94-14444 Filed 6-13-94; 8:45 am]
BILLING CODE 4160-01-F