[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
_______________________________________________________________________
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)
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Sec. 810.13(b)(3) 2 480 960
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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