[Federal Register: January 16, 2001 (Volume 66, Number 10)]
[Proposed Rules]
[Page 3523-3526]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr16ja01-22]
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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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=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]
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