[Federal Register Volume 66, Number 10 (Tuesday, January 16, 2001)]
[Proposed Rules]
[Pages 3523-3526]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-1128]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 16 and 807

[Docket No. 00N-1625]


Medical Devices; Rescission of Substantially Equivalent Decisions 
and Rescission Appeal Procedures

AGENCY: Food and Drug Administration, HHS.

ACTION: Proposed rule.

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SUMMARY: The Food and Drug Administration (FDA) is proposing 
regulations under which FDA may rescind a decision issued under the 
Federal Food, Drug, and Cosmetic Act (the act) that a device is 
substantially equivalent to a legally marketed device, and, therefore, 
may be marketed. In addition, under this proposal, a premarket 
notification (commonly known as a ``510(k)'') holder may request 
administrative review of a proposed rescission action. This proposed 
rule is being issued in order to standardize the procedures for 
considering rescissions.

DATES: Submit written comments by April 16, 2001.

ADDRESSES: Submit written comments to the Dockets Management Branch 
(HFA-305), Food and Drug Administration, rm. 1061, 5630 Fishers Lane, 
Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Heather S. Rosecrans, Center for 
Devices and Radiological Health (HFZ-404), Food and Drug 
Administration, 9200 Corporate Blvd., Rockville, MD 20850, 301-594-
1190.

SUPPLEMENTARY INFORMATION:

I. Background

    The Medical Device Amendments (Public Law 94-295) (the amendments) 
to the act (21 U.S.C. 301 et seq.) were enacted on May 28, 1976. Among 
other things, the amendments directed FDA to issue regulations 
classifying all medical devices into one of three regulatory control 
categories. The classification depends upon the degree of regulation 
necessary to provide reasonable assurance of the safety and 
effectiveness of the device.
    Under section 513(a)(1)(A) of the act (21 U.S.C. 360c(a)(1)(A)), 
class I devices are subject to a comprehensive set of regulatory 
provisions applicable to all classes of devices, e.g., registration and 
listing, prohibitions against adulteration and misbranding, and good 
manufacturing practice requirements. A class I device is exempt from 
the premarket notification requirements of the act unless it is 
intended for a use which is of substantial importance in preventing 
impairment of human health, or the device presents a potential 
unreasonable risk of illness or injury under section 510(l) of the act 
(21 U.S.C. 360(l)). Class II devices are subject to special controls as 
well as general controls. These special controls may consist of 
performance standards, postmarket surveillance, patient registries, FDA 
guidelines, or other appropriate controls under section 513(a)(1)(B) of 
the act. Class III devices require premarket approval (PMA) or a 
completed product development protocol by FDA before they may be 
marketed, unless they are class III devices for which we have not 
called for PMA's under section 515(b) of the act (21 U.S.C. 360e(b)).

II. Premarket Notification Requirements

    Section 510(k) of the act requires each person who is required to 
register and who proposes to begin the introduction or delivery for 
introduction into interstate commerce for commercial distribution of a 
device intended for human use to submit a 510(k).
    Throughout this proposal, we use the following terms:
    1. The ``510(k) submitter.''--the person who submitted the 510(k) 
to the FDA.
    2. The ``510(k) holder''--the person who possesses the rights to 
market the device that is the subject of a 510(k) substantial 
equivalence order. (The 510(k) submitter and the 510(k) holder may or 
may not be the same person.)
    3. The ``510(k) holder of record''--the person whom FDA has on file 
as being the 510(k) holder.
    The proposed rule adds these definitions to 21 CFR 807.3.
    There may be instances when 510(k) ownership has changed without 
FDA's knowledge. In the event of a proposed rescission, FDA would 
provide notice to the 510(k) holder of record. FDA would attempt to 
notify the holder of record by registered letter. FDA would also post 
notice of a proposed rescission on FDA's Center for Devices and 
Radiological Health's (CDRH) home page on the Internet at http://www.fda.gov/cdrh/index.html. To protect the privacy of the 510(k) 
holder, only the proposed rescission would be listed; the factual basis 
and reasons for the rescission would not be posted on CDRH's home page 
on the Internet.
    Under the 510(k) process, the 510(k) submitter may claim that its 
new device is substantially equivalent to a legally marketed class I or 
class II device or to a preamendments class III device that is not yet 
required to be the subject of an approved premarket approval 
application. If, after reviewing the 510(k), the agency determines that 
the device is substantially equivalent to the legally marketed device 
(as defined in 21 CFR 807.92(a)(3)), the agency will issue an order 
permitting the 510(k) submitter to market its device without the need 
for the more rigorous premarket approval under section 515 of the act.
    The criteria the agency must use to determine substantial 
equivalence are in section 513(i) of the act. Section 513(i) of the act 
defines substantial equivalence to mean that the device has the same 
intended use as the predicate device and that FDA, by order, has found 
that the device--(i) has the same technological characteristics as the 
predicate device, or (ii)--(I) has different technological 
characteristics and the information submitted that the device is 
substantially equivalent to the predicate device contains information, 
including clinical data if deemed necessary by FDA, that the device is 
as safe and effective as a legally marketed device, and (II) does not 
raise different questions of safety and effectiveness than the legally 
marketed device.
    The statute allows 510(k) marketing clearance only for devices that 
FDA determines are comparable in safety and effectiveness to a legally 
marketed device. New devices that are not substantially equivalent must 
remain in class III and meet the premarket approval requirements under 
section 515 of the act before they can be marketed, unless the device 
is reclassified under section 513(f) of the act.

[[Page 3524]]

III. Authority to Rescind

    On October 25, 1994, the Health Industry Manufacturers Association 
(HIMA) submitted a petition [Docket No. 94A-0388] to FDA in which they 
requested that FDA issue an advisory opinion stating that the act does 
not provide authority for FDA to withdraw a premarket notification 
(510(k)) order. In the alternative, HIMA requested that, if FDA 
determined that it did have the authority to withdraw a premarket 
notification order, FDA should: (1) Refrain from rescinding such a 
decision without establishing procedures assuring the 510(k) holder due 
process rights; (2) provide the 510(k) holder an opportunity for an 
informal hearing under section 201(x) (formerly 201(y)) of the act (21 
U.S.C. 321(x)) before issuing a rescission order; and (3) issue a 
regulation providing the 510(k) holder with the opportunity to request 
a hearing to challenge a proposed withdrawal.
    On September 11, 1995, FDA issued an interim response to the HIMA 
petition. In this interim response, FDA said that it intended to issue 
a proposed rule specifying the authority for rescinding a substantial 
equivalence decision as well as the grounds under which such decisions 
can be made. The interim response also stated that, pending the 
completion of this rulemaking process, FDA would only rescind, or 
propose to rescind, substantial equivalence orders in cases involving: 
(1) A serious adverse risk to public health or safety, (2) data 
integrity or fraud, or (3) other compelling circumstances. On September 
22, 1997, FDA issued a final response to the petition that restated the 
policy established in the interim response.
    Although the act does not expressly address rescission of 
substantial equivalence orders, section 513(f) and (i) of the act 
indicate that rescission is consistent with FDA's authority under the 
act to allow marketing of a device under the 510(k) process only if the 
device is substantially equivalent to a legally marketed device.
    FDA has authority under its administrative procedure regulations to 
reconsider the issuance of substantial equivalence orders Sec. 10.33(a) 
and (h) (21 CFR 10.33(a) and (h)). Section 10.33(a) states the 
``Commissioner may at any time reconsider a matter, on the 
Commissioner's own initiative or on the petition of an interested 
person.'' Section 10.33(h) states the ``Commissioner may initiate the 
reconsideration of all or part of a matter at any time after it has 
been decided or action has been taken.'' Both Sec. 10.33(a) and (h) 
provide the agency with authority to reconsider and rescind an order 
determining a device to be substantially equivalent.
    Section 10.75 (21 CFR 10.75) also provides the agency with 
authority for supervisory review of decisions made by an employee other 
than the Commissioner of Food and Drugs (the Commissioner). This 
internal review can be undertaken to resolve agency disputes, review 
policy and unusual situations affecting public interest, or as required 
by delegations of authority. Section 10.75 supports the agency's 
authority to correct the decisions that it determines were made in 
error by employees other than the Commissioner.
    Case law also supports FDA's authority to correct inappropriate 
decisions even in the absence of explicit statutory or regulatory 
authority. In American Therapeutics Inc. v. Sullivan, 755 F. Supp. 1, 2 
(D.D.C. 1990), FDA rescinded a drug approval that had been issued by 
mistake. The court held that, although there were no regulations or 
statutory provisions that expressly contemplated rescission of an 
approval by mistake, the agency must be given latitude to correct 
mistakes.
    The Supreme Court has also recognized an implied authority in 
agencies to reconsider and rectify errors, even if the applicable 
statute and regulations do not expressly provide for such 
reconsideration. For example, in concluding that the Interstate 
Commerce Commission could order a refund to correct a prior error, the 
Supreme Court stated that ``[a]n agency, like a court, can undo what is 
wrongfully done by virtue of its order.'' United Gas Improvement Co. v. 
Callery Properties, Inc., 382 U.S. 223, 229 (1965). See also American 
Trucking Association v. Frisco Trans., 358 U.S. 133, 145 (1958) (``the 
presence of authority in administrative officers and tribunals to 
correct [inadvertent ministerial] errors has long been recognized--
probably so well recognized that little discussion has ensued in the 
reported cases.''); Copley v. Elliot, 948 F. Supp. 586, 589 (W.D. Va. 
1996) (``[i]t is generally always within the power of a government 
agency to correct its mistakes.'').
    Other courts have similarly recognized this implied authority, Iowa 
Power and Light Co. v. United States, 712 F.2d 1292, 1294-97 (8th Cir. 
1983) (ICC could retroactively impose higher tariff to correct legal 
error), cert. denied, 466 U.S. 949 (1984); Bookman v. United States, 
453 F.2d 1263, 1265 (Ct. Cl. 1972) allowing agency to reconsider 
decisions in absence of statutory or regulatory authorization after 
noting general rule that ``[e]very tribunal, judicial or 
administrative, has some power to correct its own errors or otherwise 
appropriately to modify its judgment, decree, or order'') (quoting 2 K. 
Davis, Administrative Law Treatise, section 18.09 (1958)).
    Moreover, some courts have held that FDA has a duty to correct 
errors if it learns its prior position was incorrect. See United States 
v. 60 28-Capsule Bottles,. 211 F. Supp. 207, 215 (D. N.J. 1962) (FDA 
has a duty to change its position with reference to the efficacy of a 
drug if it subsequently learns that its original position was in 
error); see also Bentex Pharmaceuticals Inc. v. Richardson, 463 F.2d. 
363, 368 n. 17 (4th Cir. 1972) rev'd Weinberger v. Bentex 
Pharmaceuticals, Inc., 412 U.S. 645 (1979) (noting FDA not estopped 
from alleging product was a ``new drug,'' even though the agency had 
given the opinion that similar drugs were not ``new drugs'').

IV. Bases for Proposing Rescission of a 510(k) Substantial 
Equivalence Decision

    FDA examines a vast array of device technologies each year under 
the premarket notification (510(k)) process. Under the 510(k) process, 
each submitter has the burden of demonstrating that its device is at 
least as safe and effective as a legally marketed device. If FDA 
discovers that a premarket notification submission does not meet the 
criteria of substantial equivalence and the submission was cleared in 
error, FDA will issue a registered letter to the 510(k) holder of 
record proposing to rescind the order of substantial equivalence. FDA 
will also post notice of the proposed rescission on CDRH's home page on 
the Internet.
    Under proposed Sec. 807.103, FDA may propose rescission of a 
substantial equivalence decision if one or more of the following 
criteria are met. FDA believes that, if any one of these criteria is 
met, there is no longer reasonable assurance that the device is at 
least as safe and effective as a legally marketed device.
    1. The premarket notification does not satisfy the criteria under 
Sec. 807.100(b)(1) or (b)(2) for a determination of substantial 
equivalence.
    2. Based on new safety or effectiveness information, the device is 
not substantially equivalent to a legally marketed device.
    3. (i) FDA or the 510(k) holder has removed from the market, for 
safety and effectiveness reasons, one or more legally marketed 
device(s) on which the substantial equivalence determination

[[Page 3525]]

was based, or (ii) a court has issued a judicial order determining the 
legally marketed device(s), on which the substantial equivalence 
determination was based, to be misbranded or adulterated.
    4. The premarket notification contained or was accompanied by an 
untrue statement of material fact.
    5. The premarket notification included or should have included 
information about clinical studies and these clinical studies failed to 
comply with applicable Institutional Review Board regulations (21 CFR 
part 56) or informed consent regulations (21 CFR part 50) in a way that 
the rights or safety of human subjects were not adequately protected.
    6. The premarket notification contained clinical data submitted by 
a clinical investigator who has been disqualified under 21 CFR 812.119.
    These would be bases to rescind because information in the 510(k) 
is incorrect, incomplete, unreliable, or not evaluated properly by FDA 
in accordance with section 513(f) and (i) of the act.

V. Procedures for Rescinding a 510(k) Substantial Equivalence Order

    Before issuing an order rescinding a 510(k) substantial equivalence 
decision, FDA would notify the 510(k) holder of record of its intent to 
rescind by registered mail. This notice would state the facts upon 
which the action is based and would notify the 510(k) holder of record 
of an opportunity for a hearing under part 16 (21 CFR part 16). The 
notice would include the time within which a hearing may be requested 
and the name, address, and telephone number of the FDA employee to whom 
any request for a hearing is to be addressed. FDA would also post 
notice of a proposed rescission on CDRH's home page on the internet. 
The Internet site will only state that a rescission of the 510(k) is 
proposed and information about the hearing and will not state the facts 
upon which the action is based. Because FDA may be unaware that 
ownership of a 510(k) has changed, the notification by Internet site 
would serve as an additional means of assuring that the current 510(k) 
holder has notice.
    If FDA believes that immediate action to remove a dangerous device 
from the market is necessary to protect the public health, the agency 
may, in accordance with Secs. 16.24(d), 16.60(h) and 10.19, waive, 
suspend, or modify any part 16 procedure or procedures stated in part 
807. Ordinarily, the amount of time specified in the notice for 
requesting a hearing will be not less than 3 working days. FDA 
ordinarily would provide notice by registered mail. Under circumstances 
presenting the need for immediate action, FDA may, for example, attempt 
to contact the 510(k) holder by telephone instead of registered mail.
    If a 510(k) holder fails to request a hearing within the timeframe 
specified by FDA in the notice of opportunity for hearing, FDA will 
consider the failure to request a hearing a waiver of such hearing and 
FDA will issue a letter rescinding the order determining substantial 
equivalence.
    If, after a part 16 hearing is held, the agency decides to proceed 
with the rescission of an order determining substantial equivalence, 
FDA will issue to the 510(k) holder of record an order rescinding the 
order determining substantial equivalence. The rescission order will 
state each ground for rescinding the substantial equivalence 
determination. FDA will give the public notice of an order rescinding a 
determination of substantial equivalence. The notice will be placed on 
CDRH's home page on the Internet.

VI. Environmental Impact

    The agency has determined under 21 CFR 25.30(h) that this action is 
of a type that does not individually or cumulatively have a significant 
effect on the human environment. Therefore, neither an environmental 
assessment nor an environmental impact statement is required.

VII. Analysis of Impacts

    FDA has examined the impacts of the proposed rule under Executive 
Order 12866, the Regulatory Flexibility Act (5 U.S.C. 601-612) (as 
amended by subtitle D of the Small Business Regulatory Fairness Act of 
1996 (Public Law 104-121)), and the Unfunded Mandates Reform Act of 
1995 (Public Law 104-4)). Executive Order 12866 directs agencies to 
assess all costs and benefits of available regulatory alternatives and, 
when regulation is necessary, to select regulatory approaches that 
maximize net benefits (including potential economic, environmental, 
public health and safety, and other advantages; distributive impacts; 
and equity). The agency believes that this proposed rule is consistent 
with the regulatory philosophy and principles identified in 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, if a rule would have a significant economic impact 
on a substantial number of small entities. The proposed rule will not 
have a significant economic impact on a substantial number of small 
entities. FDA has only proposed five rescissions from 1997 through 1999 
and one rescission through May 2000. FDA does not believe that this 
level of activity represents a significant impact on a substantial 
number of small entities. In addition, the rule will be applied only 
when the criteria for rescission are met. The agency therefore 
certifies that this rule, if finalized, will not have a significant 
economic impact on a substantial number of small entities.
    Section 202(a) of the Unfunded Mandates Reform Act of 1995 requires 
that agencies prepare a written statement of anticipated costs and 
benefits before proposing any rule that may result in an expenditure by 
State, local, and tribal governments, in the aggregate, or by the 
private sector, of $100 million in any one year (adjusted annually for 
inflation). The Unfunded Mandates Reform Act does not require FDA to 
prepare a statement of costs and benefits for the proposed rule, 
because the proposed rule is not expected to result in any 1-year 
expenditure that would exceed $100 million adjusted for inflation.

VIII. Request for Comments

    Interested persons may submit to the Dockets Management Branch 
(address above) written comments regarding this proposal by April 16, 
2001. 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 Dockets Management Branch between 
9 a.m. and 4 p.m. Monday through Friday.

IX. Paperwork Reduction Act of 1995

    FDA has tentatively determined that this proposed rule contains no 
collections of information. Therefore, clearance from the Office of 
Management and Budget under the Paperwork Reduction Act of 1995 is not 
required.

List of Subjects

21 CFR Part 16

    Administrative practice and procedure.

21 CFR Part 807

    Confidential business information, Imports, Medical devices, 
Reporting and recordkeeping requirements.

    Therefore, under the Federal Food, Drug, and Cosmetic Act and under 
the authority delegated to the Commissioner

[[Page 3526]]

of Food and Drugs, it is proposed that 21 CFR parts 16 and 807 be 
amended as follows:

PART 16--REGULATORY HEARING BEFORE THE FOOD AND DRUG ADMINISTRATION

    1. The authority citation for 21 CFR part 16 continues to read as 
follows:

    Authority: 15 U.S.C. 1451-1461; 21 U.S.C. 141-149, 321-394, 
467f, 679, 821, 1034; 28 U.S.C. 2112; 42 U.S.C. 201-262, 263b, 364.

    2. Section 16.1 is amended in paragraph (b)(2) by numerically 
adding an entry for Sec. 807.103 to read as follows:


Sec. 16.1  Scope.

* * * * *
    (b) * * *
    (2) * * *
    Sec. 807.103 relating to rescission of substantially equivalent 
orders and rescission appeal procedures.
* * * * *

PART 807--ESTABLISHMENT REGISTRATION AND DEVICE LISTING FOR 
MANUFACTURERS AND INITIAL IMPORTERS OF DEVICES

    3. The authority citation for 21 CFR part 807 continues to read as 
follows:

    Authority: 21 U.S.C. 331, 351, 352, 360, 360c, 360e, 360i, 360j, 
371, 374.

    4. Section 807.3 is amended by adding new paragraphs (t), (u), and 
(v) to read as follows:


Sec. 807.3  Definitions.

* * * * *
    (t) 510(k) submitter means the person who submitted the 510(k) to 
FDA.
    (u) 510(k) holder means the person who possesses the rights to 
market a device that is the subject of 510(k) substantial equivalence 
order.
    (v) 510(k) holder of record means the person FDA has on file as 
being the holder of the 510(k).
    5. Section 807.103 is added to subpart E to read as follows:


Sec. 807.103  Rescission of 510(k) substantially equivalent orders and 
rescission appeal procedures.

    (a) Grounds for rescinding a substantially equivalent order. FDA 
may issue an order rescinding a determination of substantial 
equivalence under this section, if FDA determines that any one of the 
following grounds exist:
    (1) The premarket notification does not satisfy the criteria under 
Sec. 807.100(b)(1) or (b)(2) for a determination of substantial 
equivalence.
    (2) Based on new safety or effectiveness information, the device is 
not substantially equivalent to a legally marketed device.
    (3) (i) FDA or the 510(k) holder has removed from the market, for 
safety and effectiveness reasons, one or more legally marketed 
device(s) on which the substantial equivalence determination was based, 
or
    (ii) A court has issued a judicial order determining the legally 
marketed device(s) on which the substantial equivalence determination 
was based to be misbranded or adulterated.
    (4) The premarket notification contained or was accompanied by an 
untrue statement of material fact.
    (5) The premarket notification included or should have included 
information about clinical studies and these clinical studies failed to 
comply with applicable institutional review board regulations (part 56 
of this chapter) or informed consent regulations (part 50 of this 
chapter) in a way that the rights or safety of human subjects were not 
adequately protected.
    (6) The premarket notification contained clinical data submitted by 
a clinical investigator who has been disqualified under Sec. 812.119 of 
this chapter.
    (b) Notice of proposed rescission and opportunity for a hearing. 
Before issuing an order rescinding a substantial equivalence order, FDA 
will issue the 510(k) holder of record a notice of the agency's intent 
to rescind the 510(k) by registered letter, together with a notice of 
an opportunity for an informal hearing under part 16 of this chapter. 
FDA will also post notice of a proposed rescission on the FDA's Center 
for Devices and Radiological Health's (CDRH) home page on the Internet 
at http://www.fda.gov/cdrh/index.html. If FDA believes that immediate 
action to remove a dangerous device from the market is necessary to 
protect the public health, the agency may, in accordance with 
Secs. 16.24(d), 16.60(h), and 10.19 of this chapter, waive, suspend, or 
modify any part 16 procedure and, in accordance with this section, 
waive, suspend, or modify any part 807 procedure.
    (c) Failure to request a hearing. If a 510(k) holder fails to 
request a hearing within the timeframe specified by FDA in the notice 
of opportunity for hearing, FDA will consider the failure to request a 
hearing a waiver of such hearing and FDA will issue a letter rescinding 
the order determining substantial equivalence.
    (d) Rescission order. If the 510(k) holder does not request a 
hearing or if, after proceedings in accordance with this part and part 
16 of this chapter are completed, the agency decides to proceed with 
the rescission of an order determining substantial equivalence, FDA 
will issue to the 510(k) holder of record an order rescinding the order 
determining substantial equivalence. The rescission order will state 
each ground for rescinding the substantial equivalence determination.
    (e) Public notice of final action. FDA will give the public notice 
of the order rescinding a determination of substantial equivalence. If 
FDA determines not to finalize a proposed rescission, FDA will also 
give the public notice of this determination. These notices will be 
placed on FDA's home page on the Internet.

    Dated: January 5, 2001.
Ann M. Witt,
Acting Associate Commissioner for Policy.
[FR Doc. 01-1128 Filed 1-12-01; 8:45 am]
BILLING CODE 4160-01-F