[Federal Register Volume 59, Number 239 (Wednesday, December 14, 1994)]
[Unknown Section]
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From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-30422]


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[Federal Register: December 14, 1994]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 807

[Docket No. 91N-0388]

 

Medical Devices; Substantial Equivalence; 510(K) Summaries and 
510(K) Statements; Class III Summaries; Confidentiality of Information

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

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SUMMARY: The Food and Drug Administration (FDA) is issuing this final 
rule to implement the provisions of the Safe Medical Devices Act of 
1990 (the SMDA) that require all persons who submit a premarket 
notification (510(k)) to provide to FDA, as part of the submission, an 
adequate summary (510(k) summary) of any information respecting safety 
and effectiveness or a statement (510(k) statement) that such 
information will be made available upon request by any person. This 
rule also implements the requirement of the SMDA that 510(k) submitters 
claiming substantial equivalence to a class III preamendments device 
for which FDA has not yet called for premarket approval submit a class 
III summary and certify that they have conducted a search of safety and 
effectiveness data. In addition, this rule amends the device 
regulations governing the confidentiality of certain premarket 
notification submissions to conform to the SMDA. This rule also 
provides that persons who submit a premarket notification must certify 
that, to the best of their knowledge, all information is truthful and 
accurate and that no material fact has been omitted.

EFFECTIVE DATE: March 14, 1995.

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

    In the Federal Register of April 28, 1992 (57 FR 18062), FDA issued 
an interim rule implementing the provisions of the SMDA that require 
persons who submit premarket notifications under section 510(k) of the 
Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 360(k)) to 
include an adequate summary of any information on safety and 
effectiveness (510(k) summary) or a statement (510(k) statement) that 
such information will be made available upon request by any person. The 
interim rule also implemented the requirement that 510(k) submitters 
claiming substantial equivalence to a class III preamendments device 
for which FDA has not yet called for premarket approval certify (class 
III certification) that they have conducted a search of safety and 
effectiveness data concerning the device and submit a summary of, and a 
citation to, all adverse safety and effectiveness information 
respecting the device (class III summary). In addition, the interim 
rule amended the device regulations governing the confidentiality of 
certain premarket notification submissions to conform to the SMDA. The 
interim rule also provided that persons who submit a premarket 
notification must certify that the data and information are truthful 
and accurate and that no material fact has been omitted. FDA stated 
that the interim rule would become effective on May 28, 1992.
    Interested persons were given until June 29, 1992, to comment on 
the interim rule. In the Federal Register of June 1, 1992 (57 FR 
23059), this comment period was extended until August 27, 1992, in 
response to a petition filed by a trade association. The effective date 
was stayed by FDA until the comments were reviewed and a new rule was 
published and made effective.

II. Comments

    The agency received 19 comments from trade associations, 
manufacturers, a supplier, and a medical device consultant. A summary 
of the comments and the agency's response to them is provided below:
    1. One comment from a manufacturer questioned why Sec. 807.87(i)(2) 
(21 CFR 807.87(i)(2)) of the interim rule stated that information that 
already has been submitted to FDA under section 519 of the act (21 
U.S.C. 360i) is not the type of information that would be included in a 
class III summary. Section 519(a) of the act (21 U.S.C. 360i(a)) 
authorizes FDA to issue regulations requiring the manufacturers of 
devices to maintain and provide records to ensure that devices are not 
adulterated, misbranded, unsafe, or ineffective.
    The SMDA (513(f)(3)) of the act (21 U.S.C. 360c(f)(3)) specifically 
excludes all adverse safety and effectiveness data that have been 
submitted to FDA under section 519 of the act from class III summaries 
(summaries submitted by manufacturers claiming substantial equivalence 
to a class III preamendments device for which FDA has not yet called 
for a PMA). Although the statute does not require manufacturers to 
submit such data more than once, the agency understands that a class 
III summary may include information that has previously been submitted 
under section 519 of the act.
    2. Many comments argued that the certification requirement in 
Sec. 807.87(j) of the interim rule should be deleted because FDA can 
utilize existing programs and statutes to ensure that erroneous 
information is not submitted to the agency. One comment further argued 
that FDA cannot require the regulated community to certify the 
completeness of any 510(k) submission because that completeness is 
subject to a variety of interpretations.
    As noted in the preamble to the interim rule, this certification 
requirement was added in response to a July 1990 report by the Office 
of the Inspector General (OIG) on internal controls covering the 510(k) 
review process. In that report, the OIG stated that, ``because the 
generic drug approval scandal has raised concern about industry's 
behavior under the so-called `honor system,' we believe that the 510(k) 
process needs a program to help ensure that what industry reports on 
paper is in fact accurate.'' The OIG recommended requiring industry to 
certify the accuracy of data submitted in 510(k) submission documents 
in order to enhance the integrity of the 510(k) premarket notification 
process. (See page 22 of OIG report). The agency believes that such a 
requirement provides additional assurance that the data submitted are 
complete and accurate. However, in response to the comment that 
concerned the inability of any individual to know if information is 
complete, FDA has modified the language in Sec. 807.87(j) to include 
the phrase ``to the best of his or her knowledge.'' This certification 
should be made by an industry representative, preferably the official 
correspondent of the firm.
    3. Several comments complained that FDA improperly expanded the 
scope of the information required by the SMDA for summaries ``of any 
information respecting safety and effectiveness'' by requiring such 
summaries to contain ``data and information supporting a finding of 
substantial equivalence, including all adverse safety and effectiveness 
information.'' A few comments noted that FDA's decision to treat all 
information submitted in support of a substantial equivalence 
determination as ``safety and effectiveness'' information seems 
contrary to the notion that ``substantial equivalence'' determinations 
are, on their face, determinations of ``equivalence,'' and not of 
safety and effectiveness. One comment cited an FDA publication on 
510(k) requirements, which stated, ``The purpose of data, such as 
clinical data, for a premarket notification submission is to 
demonstrate that the device is equivalent in performance to the 
preamendments device. FDA does not intend that the data determine the 
device's safety and effectiveness.'' See ``Premarket Notification: 
510(k) Regulatory Requirements for Medical Devices,'' HHS Publication 
FDA 90-4158, August 1990, p. 2. Another comment stated that information 
concerning device design, intended use, or technological 
characteristics is useful information which may support a determination 
of substantial equivalence, but may not support a determination of 
safety and effectiveness.
    FDA believes that Congress clearly intended the concept of 
``substantial equivalence'' to include some inquiry into the safety and 
effectiveness of a new device, and that such inquiries into safety and 
effectiveness are often inseparable from other bases of determining 
substantial equivalence. The Report by the Committee on Interstate and 
Foreign Commerce on the Medical Device Amendments of 1976 (House 
Report) indicates that ``substantial equivalence'' is to be assessed 
not only in relation to physical characteristics and intended use, but 
sometimes also in terms of safety and effectiveness. The committee 
believed that the term ``substantially equivalent'' ``should be 
construed narrowly where necessary to assure the safety and 
effectiveness of a device but not so narrowly where differences between 
a new device and a marketed device do not relate to safety and 
effectiveness.'' (H. Rept. No. 94-853, p. 36.)
    The 1976 amendments, therefore, provided FDA with statutory 
authority to consider the safety and effectiveness of a device when 
determining whether such a device is substantially equivalent to a 
predicate device. The legislative history of the 1990 amendments states 
Congress' express intent to codify FDA's interpretation of the term 
``substantial equivalence,'' including the agency's determination that 
substantial equivalence requires a finding of comparable safety and 
effectiveness (S. Rept. 513, 101st Cong., 2d sess. 41 (1990)). 
Accordingly, Sec. 807.3 (21 CFR 807.3), which defines a 510(k) summary 
to be ``a summary * * * of the safety and effectiveness information 
contained in a premarket notification submission upon which a 
determination of substantial equivalence can be based'' merely codifies 
the agency's long-standing interpretation, approved by Congress, that 
safety and effectiveness can be an integral part of a substantial 
equivalence determination. The agency has concluded, therefore, that 
the requirement that summaries of safety and effectiveness data include 
information supporting a finding of substantial equivalence is 
consistent with legislative intent and agency practice.
    4. One comment stated that FDA should revise the language on page 
18062 of the interim rule which reads, ``FDA's decision regarding the 
existence of substantial equivalence will be based on all the 
information contained in the 510(k), not only the information contained 
in the summary,'' to read as follows: ``FDA's decision regarding the 
existence of substantial equivalence will be based on all the 
information contained in a 510(k).'' This comment believed that the 
510(k) summary is intended to be a synopsis of safety and effectiveness 
information for requestors, and is not intended for the use of FDA 
reviewers when arriving at determinations of substantial equivalence. 
Therefore, this comment suggested that the phrase ``510(k) safety and 
effectiveness summary'' be inserted in lieu of the term ``510(k) 
summary'' throughout the rule.
    FDA agrees in part with this comment. As stated in the interim 
rule, FDA's decision regarding the existence of substantial equivalence 
will be based on all the information contained in the 510(k), not only 
the information contained in the summary. However, the agency does not 
agree that a change in terminology would significantly increase the 
clarity of the rule and does not believe that the term ``510(k) 
summary'' needs to be replaced with ``510(k) safety and effectiveness 
summary'' throughout the rule.
    5. One comment stated that the portion of the 510(k) summary 
required in Sec. 807.92(a)(5) (21 CFR 807.92(a)(5)), ``statement of 
intended use,'' should include definitions of the differences between 
the submitter's new device and the legally marketed device, if the 
indication statements are not the same. This comment further stated 
that the brief discussion of nonclinical tests required as part of the 
510(k) summary under Sec. 807.92(b)(1) should include references. The 
comment further stated that the requirement should state clearly that 
conclusions drawn from test results should compare the device with 
legally marketed devices (Sec. 807.92(a)(3)).
    The agency agrees in part with this comment. FDA believes that the 
interim rule required sufficient detail about the intended use of the 
device and its predicate. However, the agency has revised 
Sec. 807.92(a)(5) on intended use to clarify that substantial 
equivalence claims can only be made to predicates that are legally 
marketed. With respect to the comment that conclusions from test 
results should compare the device with legally marketed devices, 
Sec. 807.92(b)(3) does require ``conclusions drawn from the nonclinical 
and clinical tests that demonstrate that the device is as safe, as 
effective, and performs as well as or better than the legally marketed 
device * * *.'' Therefore, no revision of this provision is warranted.
    6. One comment recommended that 510(k) summaries need include only 
information required by Sec. 807.92(b)(3), which concerns conclusions 
drawn from nonclinical and clinical tests that demonstrate comparable 
safety, effectiveness, and performance of a new device to a legally 
marketed device, as intended by Congress. Another comment also 
recommended reducing the amount of information required in a 510(k) 
summary, noting that information of a descriptive nature is sufficient 
in most cases to allow a determination of substantial equivalence. This 
comment argued that requiring 510(k) summaries to include clinical and 
preclinical data in cases where such data are not necessary, would 
require needless and costly data preparation and FDA review.
    The agency has always required 510(k) submissions to include 
descriptive data that are necessary to understand the indication, 
physical composition, method of operation, specifications, or 
performance claims of the device. Also, the agency has always required 
any descriptive data about the legally marketed device that are 
necessary to understand the characteristics of the device to which the 
new device is being compared. A legally marketed device to which a new 
device may be compared is a predicate device (device legally marketed 
prior to May 28, 1976, or a device which has been classified from class 
III to class II or class I), or a device which has been found to be 
substantially equivalent through the 510(k) premarket notification 
process. In order to clarify the definition of a legally marketed 
device to which a new device may be compared for a determination 
regarding substantial equivalence, the agency is amending 
Sec. 807.92(a)(3) to include this definition of a legally marketed 
device.
    The new requirement for 510(k) summaries does not change or add to 
the type of information that must be included in a 510(k) submission. 
However, FDA has modified the language of Sec. 807.92(a)(4) to clarify 
that descriptive information required for a 510(k) summary is expected 
to be a condensed and summarized version of information in a 510(k) 
submission, similar to labeling or promotional descriptions.
    To date, the agency has required or used clinical investigation 
data in less than 10 percent of its premarket notification submissions. 
The agency generally requires clinical data when the description of a 
new device indicates an important difference in comparison to marketed 
devices within its type, i.e., new material or method of operation of 
the new device. The agency may also require performance data when 
descriptive characteristics of the new device are not sufficiently 
precise to ensure that the new device, when manufactured according to 
its description, will be comparable to the legally marketed device.
    The legislative history of the SMDA explicitly supports FDA's 
practice of requesting additional data in this regard in order to 
determine substantial equivalence.

    The determination of comparable safety and effectiveness is at 
times easy, where the newer device and its predicate use the same 
technologies. More difficult judgments occur when the technologies 
of the devices differ. In this latter situation, FDA will not make a 
substantial equivalence determination without data, including 
clinical data, that demonstrates comparable safety and effectiveness 
(S. Rept. 513, 101st Cong., 2d sess. 28 (1990)).

    7. One comment suggested that the agency release the entire 510(k), 
excluding trade secret and specific patient information, in lieu of 
requiring safety and effectiveness summaries. In the alternative, this 
comment suggested making the information required by Sec. 807.92(b) 
part of the 510(k) cover letter supplied by the 510(k) submitter, and 
then making the entire cover letter releasable because that letter 
would ordinarily include the information requested in Sec. 807.92(a).
    The agency disagrees. The release of either the entire 510(k), 
excluding trade secret information and patient identifiers, or release 
of the 510(k) cover letter, in lieu of the 510(k) submitter's 510(k) 
summary would be inconsistent with the SMDA. Section 513(i) of the SMDA 
expressly requires 510(k) submitters to submit summaries of information 
that are intended for public disclosure respecting safety and 
effectiveness or to state that such information will be made available 
upon request by any person (21 U.S.C. 360c(i)(3)). There is no basis in 
the legislation to require FDA to create summaries or substitutes for 
summaries. However, if 510(k) submitters choose to have the entire 
510(k), excluding patient identifiers and trade secret and confidential 
commercial information, released in lieu of a 510(k) summary, they may 
elect to submit a 510(k) statement and then release that information 
themselves in response to requests from the public.

A. Trade Secret/Confidential Information

    8. A few comments stated that FDA is precluded by the Freedom of 
Information Act (the FOIA), 5 U.S.C. 552, and the act from divulging 
trade secret information. Many comments believed that virtually all of 
the technological information required by the interim rule to be made 
public can qualify as trade secret information, even under the narrow 
definition of ``trade secret'' adopted by the D.C. Court of Appeals in 
Public Citizen Health Research Group v. Food and Drug Administration, 
704 F.2d 1280, 1288 (D.C. Cir. 1983). Specifically, these comments 
argued that the ``significant physical and performance characteristics 
of the device such as device design, materials used, and physical 
properties,'' constitute a commercially valuable plan, formula, or 
process. Similarly, the chemical composition of various reagents and 
controls, to the extent that nonactive ingredients are involved, would 
also implicate the types of information that are normally closely 
guarded as trade secrets by a 510(k) submitter.
    The agency does not intend that submitters include trade secret or 
confidential commercial information in the 510(k) summaries, which 
Congress expressly intended for public disclosure. In addition, ``the 
using by any person to his own advantage, or revealing, other than to * 
* * the Department, or to the courts * * * any information acquired 
under authority of section * * * 510 * * * concerning any method or 
process which as a trade secret is entitled to protection'' is 
prohibited under the act. (See section 301(j) of the act (21 U.S.C. 
331(j))). The requirements set forth in Sec. 807.92(a)(4) and (a)(6) 
have been modified to reflect the agency's intention that trade secret 
and confidential commercial information be protected. For example, the 
agency now states in Sec. 807.92(a)(4) that information concerning a 
device's description may be information that a firm would disclose in 
its device labeling or promotional material. The term ``statement'' in 
Sec. 807.92(a)(6) has been replaced with ``summary'' to reflect the 
agency's expectation that information provided concerning technological 
characteristics will be provided in summary fashion, in a form that is 
clear, concise, and adequate, but not so detailed as to disclose trade 
secret information. As stated in the interim rule, if a premarket 
notification submission contains only descriptive information to 
support substantial equivalence, the 510(k) summary for that submission 
would be required to contain only general information about the device 
and a summary of the descriptive information that demonstrates the new 
device is as safe and effective as the device to which the sponsor is 
requesting substantial equivalence.
    If a 510(k) submitter, however, fails to comply with the provisions 
concerning 510(k) summaries or 510(k) statements, the agency may 
provide the public with a purged copy of the 510(k) submission prepared 
by agency staff. Under these circumstances, FDA would not follow 
predisclosure notification procedures established for responses to FOIA 
requests for 510(k) records.
    9. One comment stated that because the interim rule transcends the 
provisions of the FOIA, there must be an independent legal basis 
authorizing disclosure of trade secret information prohibited from 
release by the Trade Secrets Act (the TSA), 18 U.S.C. 1905. Citing 
Chrysler Corp. v. Brown, 441 U.S. 281 (1979), this comment argued that 
while ``properly promulgated, substantive agency regulations have the 
`force and effect of law','' an interpretative regulation does not have 
the force and effect of law necessary to obviate the restrictions in 
the TSA. Id. at p. 295 and 302. Thus, for agency action to qualify as 
``authorized by law,'' under TSA, ``* * * it must have certain 
substantive characteristics and be the product of certain procedural 
requisites.'' Id. at p. 301. This comment noted that, in the preamble 
to the interim rule, FDA concluded that the regulation is not a 
substantive rule. Therefore, this comment argued, the regulation cannot 
qualify as a regulation authorized by law under the TSA. Furthermore, 
the comment continued, even if the interim rule had been labeled a 
substantive rule, it would still not have the ``force and effect'' of 
law because it was signed by the Acting Deputy Commissioner for Policy 
who lacks authority to unilaterally issue rules under either the TSA or 
the FOIA.
    The agency disagrees. FDA's statutory authority for requiring 
disclosure of particular information in a 510(k) summary is section 513 
of the act, in which Congress expressly required release to any person 
of such summaries. Congress also specifically authorized the Secretary 
of the Department of Health and Human Services (the Secretary) to 
establish the content of those summaries. The agency, therefore, 
believes that a regulation promulgated to implement that section may 
provide proper authorization for disclosure.
    However, whether or not the analysis set forth in the comment 
submitted to the agency is correct, the objections raised by that 
comment are now irrelevant. As explained above, FDA does not expect 
510(k) summaries to include trade secret or confidential commercial 
information. In addition, the agency is modifying its statement, in the 
interim rule, that a dispute over the adequacy of information provided 
by a 510(k) statement submitter should require the release to the 
requestor of confidential commercial information that is also 
considered safety and effectiveness information. The agency has 
concluded that a dispute over the adequacy of information provided in 
support of a 510(k) statement should not require automatic disclosure 
by the submitter of information that is properly protected from public 
release. However, if the agency determines that a submitter is 
attempting to undermine the 510(k) statement process by providing 
information to requestors that is untimely or inadequate, such actions 
will be deemed a prohibited act under section 301(q)(2) and (p) of the 
act, and the agency will use a variety of means, including its 
enforcement tools, to end violations. For example, in response to valid 
complaints from requestors, FDA may choose to make purged copies of the 
510(k) publicly available. (See also section III. of this document).
    10. One comment stated that FDA's apparent abandonment of any 
effort toward confidentiality raises serious concerns about proprietary 
interests, intellectual property protection, liability issues, and 
market timing. Indeed, another comment argued that the disclosure of 
trade secret or confidential information results in a taking without 
just compensation.
    As noted in paragraphs 8 and 9 of this document, FDA recognizes its 
obligation to protect information that is exempt or prohibited from 
public disclosure, and the agency does not expect 510(k) summaries to 
include such information.
    11. A few comments stated that the interim rule will compel small 
manufacturers to seek costly patent protection and discourage 
innovation. One comment noted that many small entrepreneurs believe 
that the expense of seeking patent protection is not warranted if the 
characteristics of an otherwise patentable invention cannot be easily 
ascertained through reverse engineering. However, this comment 
continued, the effect of the interim rule would compel these small, 
start-up companies to seek expensive and unnecessary patent protection 
to protect trade secrets.
    This final rule clarifies FDA's position that trade secret and 
confidential commercial information need not be included in a 510(k) 
statement or 510(k) summary. The agency takes this opportunity, 
however, to remind manufacturers and submitters of 510(k)'s that 
details about manufacture, composition, specification, performance, and 
testing that are included in labeling or promotional materials cannot 
be considered confidential under any circumstances.

B. 510(k) Summaries and Predisclosure Notification

    12. One comment disputed the notion that information contained in a 
510(k) submission is exempt from predisclosure requirements set forth 
in Executive Order 12600. This comment believed that this exemption 
should apply only to the information contained in a 510(k) summary, 
rather than to the information contained in the actual 510(k) 
submission. This comment maintained that a submitter should be afforded 
the opportunity to submit a 510(k) summary prior to disclosure of the 
information contained in a 510(k) submission.
    FDA agrees. The premarket notification submission ordinarily is 
subject to predisclosure notification under Executive Order 12600. 
However, 510(k) summaries are prepared by submitters who know that 
these summaries are intended for public disclosure. In light of the 
statute and the agency's implementing regulation, submitters can have 
no reasonable expectation that such documents will be withheld. 
Accordingly, it would be unnecessary and inappropriate to subject 
510(k) summaries to predisclosure notification. It is the 510(k) 
submitter's obligation to prepare either a 510(k) summary of any 
information respecting safety and effectiveness or provide a 510(k) 
statement that the 510(k) submitter will make such information 
available upon request.
    With respect to the decision about whether to submit a 510(k) 
summary or 510(k) statement, FDA is correcting the statement in the 
preamble to the interim rule that this decision by the 510(k) submitter 
may not be changed once the 510(k) submission has been received by FDA. 
Instead, FDA now clarifies that a 510(k) submitter who elects to submit 
a 510(k) summary when the premarket notification submission is filed, 
may, before a substantial equivalence determination is reached, submit 
either a revised 510(k) summary or a 510(k) statement in lieu of the 
510(k) summary. Likewise, a 510(k) submitter who elects to submit a 
510(k) statement when the premarket notification submission is filed, 
may, before the substantial equivalence determination is reached, 
submit a 510(k) summary in lieu of the 510(k) statement.

C. 510(k) Statements

    13. Several comments said that Sec. 807.93 (21 CFR 807.93) places a 
manufacturer who submits a 510(k) statement at risk to provide all 
information, including trade secret or confidential commercial 
information that relates to safety and effectiveness. Indeed, FDA 
specifically concluded that manufacturers could not withhold such 
information (see 57 FR 18062 at 18064).
    The interim rule specifically requested comments on this issue and, 
as noted above, the agency has changed its earlier interpretation.
    14. A few comments noted that there is no rational basis for FDA to 
treat 510(k) statements differently than 510(k) summaries for 
confidentiality purposes. These comments asserted that Congress 
provided two distinct options for 510(k) submitters in the SMDA, the 
510(k) summary or the 510(k) statement. However, if FDA continues with 
its current interpretation, the 510(k) statement undoubtedly would fall 
into disuse because 510(k) submitters would choose not to release their 
trade secret or confidential commercial information. Another comment 
stated that FDA should clearly state that the selection of a 510(k) 
statement by the submitting firm should be equally acceptable to the 
agency and should not adversely affect the review process of the 
510(k).
    FDA agrees with these comments. The SMDA was not intended to deter 
the submission of a 510(k) statement. Indeed, it provided 510(k) 
submitters with two alternatives. The disparate treatment of the 510(k) 
statement and 510(k) summary for confidentiality purposes in the 
interim rule was incorrect. However, while FDA can implement disclosure 
of 510(k) summaries that have been filed with the agency, FDA does not 
have similar control over disclosure of information promised by 510(k) 
statements. As stated above, noncompliance with the commitment made in 
a 510(k) statement will be deemed prohibited acts under section 301 
(q)(2) and (p) of the act and FDA will use its enforcement powers to 
obtain compliance.
    15. One comment stated that the certification language in 
Sec. 807.93 contradicts FDA's prior advice concerning 510(k) 
statements. The comment noted FDA's previous statement that 510(k) 
statements should be submitted instead of 510(k) summaries until FDA 
determined the content of 510(k) summaries, and FDA's previous 
statement that trade secret and confidential commercial information 
contained in a 510(k) that was the subject of a 510(k) statement need 
not be disclosed to the public. Another comment stated that fairness 
required the agency to clarify that the 510(k) submitters who relied on 
existing laws and regulations, and on previous FDA advice concerning 
confidentiality prior to the effective date of any interim rule 
changing such protections, are entitled to withhold trade secret and 
confidential commercial information.
    FDA believes the concerns raised by this comment have been 
addressed above. As noted in response to previous comments, the agency 
does not intend to require 510(k) submitters to make public disclosures 
of true trade secret or confidential commercial information.
    16. Several comments proposed changes to the wording for 
certification of 510(k) statements under Sec. 807.93. One comment 
suggested: ``I certify * * * will make available all information 
included in this premarket notification on safety and effectiveness, 
except trade secret and/or confidential information, that supports a 
finding of substantial equivalence * * *.''
    Other comments suggested revising Sec. 807.93 to read as follows:

    I certify that (contact person for the premarket notification) 
will make available all information included in this premarket 
notification on safety and effectiveness as identified in 
Sec. 807.92 of this rule that supports a finding of substantial 
equivalence within thirty (30) days of request by any person. The 
information I agree to make available does not include confidential 
patient identifiers.

    FDA has incorporated elements of all these comments into the final 
rule. The agency has modified the certification requirement so that it 
is consistent with FDA's regulations prohibiting the disclosure of 
trade secret and confidential commercial information. The statement 
also has been changed to clarify that the commitment to release 
information only becomes effective after a device has been determined 
to be substantially equivalent. The agency has also amended the 
certification language in Sec. 807.93 to reflect FDA's expectation that 
the official correspondent in the firm will prepare the certification 
on behalf of the firm.
    The certification now states:

    I certify that, in my capacity as (the position held in company 
by person required to submit the premarket notification, preferably 
the official correspondent in the firm), of (company name), I will 
make available all information included in this premarket 
notification on safety and effectiveness within 30 days of request 
by any person if the device described in the premarket notification 
submission is determined to be substantially equivalent. The 
information I agree to make available will be a duplicate of the 
premarket notification submission, including any adverse safety and 
effectiveness information, but excluding all patient identifiers, 
and trade secret and confidential commercial information as defined 
in 21 CFR 20.61.

    17. The agency received comments that indicated uncertainty about 
the scope of the obligation of a 510(k) statement submitter to respond 
to requests for safety and effectiveness information that are made 
after the ownership of the 510(k) has changed, the device is no longer 
marketed, or the firm is no longer in business.
    The legislative history of the SMDA is silent on this issue. The 
agency has concluded that the firm submitting the 510(k) statement has 
a continuing obligation to comply with the 510(k) statement commitment, 
unless the firm relieves itself of this obligation by requiring the new 
510(k) holder to submit a 510(k) statement in accordance with 
Sec. 807.93 to the agency in the situation where there has been a 
transfer of ownership of a 510(k). In those cases, the original 510(k) 
holder should inform any requesters of the transfer of obligation that 
accompanied the transfer of ownership. If a firm ceases to market the 
device, but continues to do business, it must continue to comply with 
requests for information. However, if the firm goes out of business and 
there has been no transfer of ownership, the agency will, upon 
sufficient written notification, relieve the firm of its obligation to 
honor requests for safety and effectiveness information from the 
premarket notification submission. Under these circumstances, FDA will 
release the entire premarket notification submission excluding patient 
identifiers and any information that remains trade secret or 
confidential commercial information.
    18. Another comment suggested that the regulation identify the 
kinds of documents that the public may have access to when requesting 
safety and effectiveness information from a 510(k) statement submitter. 
This comment noted that this could be accomplished by codifying the 
statement in the preamble, ``FDA believes that the information a 
submitter is required to furnish should be taken only from the 
information contained in the premarket notification submission.''
    FDA believes that the concern raised by this comment has been 
addressed by the change in the language of Sec. 807.93. That regulation 
clearly restricts the obligation of a 510(k) submitter to provide only 
information that is contained in the premarket notification. The 
regulation requires 510(k) holders who submit statements to provide 
requestors with a duplicate of their premarket notification submission, 
including any adverse information, but excluding patient identifiers 
and trade secret or confidential information. (See 21 CFR 807.93(c)). 
FDA believes that the establishment of this procedure for 510(k) 
statement submitters is in furtherance of the act. The regulation 
ensures that disclosures will be uniform to all requesters, that 
preparation of the information for disclosure need be done only one 
time by the submitter, and that confidential commercial and trade 
secret information remains protected. FDA notes that 510(k) submissions 
for any device found to be substantially equivalent have been available 
to the public under the FOIA since 1976.
    19. One comment stated that FDA should permit a 510(k) statement to 
appear without any certification language, using a format such as the 
following: ``Information in this 510(k) respecting safety and 
effectiveness will be made available upon request by any person.'' 
Another comment noted that section 513(i) of the statute does not 
require this statement to be made in the form of a ``certification.''
    Although the statute does not expressly require ``certification,'' 
FDA does not agree that certification language should be eliminated 
from the 510(k) statement. The agency believes that certification 
provides additional assurance that submitters will comply with their 
statutory obligations.

D. Timeframes

    20. A couple of comments argued that there is no basis for the 
agency's choice of a 30-day time limit for 510(k) statement submitters 
to respond to requests for safety and effectiveness information. One 
comment requested that FDA revise this timeframe to 90 days. Other 
comments noted that there is no indication that the agency has 
considered the burden that such a timeframe imposes upon a submitter, 
or whether the burden could be offset by charging requesters for the 
review time, assembly time, duplication, and mailing of the 
information.
    FDA believes that the equal choice provided by the statute for 
510(k) submitters to submit either 510(k) summaries or 510(k) 
statements indicates the intent of Congress that information should be 
available to requesters at the same time after a finding of substantial 
equivalence, without regard to the 510(k) submitter's choice of 510(k) 
summary or 510(k) statement.
    The agency has determined that imposing a 30-day timeframe on 
510(k) statement submitters is not unduly burdensome. The agency 
expects that 510(k) submitters who elect to file 510(k) statements will 
begin purging the 510(k) submission at the time they file their 
premarket notification submission.
    The agency recognizes that some firms that currently have a 510(k) 
under review may not have purged copies of their 510(k) submissions 
ready for disclosure. Section 519(a)(i) of the act states that FDA 
shall not impose requirements unduly burdensome to a device 
manufacturer, taking into account the cost of complying with such 
requirements and the need for protection of the public health and the 
implementation of the act. The agency is establishing an effective date 
of 90 days for this final rule. The agency believes that this will give 
510(k) statement submitters whose 510(k)'s are under review, sufficient 
time to prepare this information. After the 90 days have elapsed, the 
agency will expect companies to comply with requests for information 
within 30 days of receiving such requests.
    The agency believes that 510(k) submitters may not charge 
requestors for compiling and disseminating the data because such 
charges would be inconsistent with congressional intent. Charges to 
requestors could discourage disclosure of information Congress has 
determined should be made available to the public. In addition, it 
would be difficult for the agency to determine or monitor reasonable 
fees for disclosure by 510(k) submitters. If a 510(k) submitter decides 
that the preparation and dissemination of this information is too 
costly, the firm may elect to submit a 510(k) summary in lieu of a 
510(k) statement. A 510(k) summary can be submitted to the agency in 
lieu of a 510(k) statement at any time before the substantial 
equivalence determination is made. In that case, costs associated with 
release of information to requestors will be standardized and 
implemented by FDA.
    21. Another comment suggested that the timeframe for providing 
requestors with safety and effectiveness data in support of a 
substantial equivalence determination should be 30 business days, 
rather than 30 calendar days, and that all requests should be addressed 
in writing to the official correspondent of the company. This comment 
also suggested that the agency include language in the regulation that 
would prohibit disclosure of this information to a company's 
competitors without a substantiating justification. The comment also 
stated that the rationale for the request should be known to the 
company, and that all costs associated with the request should be borne 
by the requestor.
    The agency has determined that 30 calendar days, rather than 30 
business days, is an appropriate timeframe because it is FDA's 
expectation that such information will be prepared at or near the time 
of the premarket notification submission. (See FDA's response to 
comment 26 of this document). FDA also disagrees with the suggestion 
that the agency's regulation should limit access to the data. There is 
no provision in the statute that requires requestors to provide a 
rationale for making their request for safety and effectiveness 
information, or precludes them from sharing this information with any 
other person, including competitors. Indeed, under FDA's current 
regulations, the contents of a 510(k) submission are available for 
public disclosure after FDA makes a determination of substantial 
equivalence, so long as patient identifiers, trade secret, and 
confidential commercial information are deleted. Such disclosures under 
the FOIA are made without regard to the purpose or identity of the 
requestor.
    The new regulation, therefore, is entirely consistent with current 
agency disclosure practices and should be familiar to many companies 
who have previously prepared 510(k) submissions for public disclosure. 
The agency believes that these final regulations and FDA's other public 
information regulations protect trade secret and confidential 
commercial information from public disclosure by providing 510(k) 
submitters the opportunity to delete proprietary information from their 
records. Accordingly, competitors will not gain an unfair competitive 
advantage when 510(k) statement submitters release the information they 
have pledged to disclose.
    FDA does agree that all requests for information should be made to 
the official correspondent of the company or the person whose name 
appears on the list of premarket notification submissions found 
substantially equivalent. This list is available from the Dockets 
Management Branch (HFA-305), Food and Drug Administration, rm. 1-23, 
12420 Parklawn Dr., Rockville, MD 20857. The agency believes that 
directing the request to one person within the firm will expedite the 
dissemination of this information. The agency has modified 
Sec. 807.93(b) accordingly. The issue of payment by requestors of 
information to 510(k) submitters who have made 510(k) statements has 
been addressed previously in paragraph 21 of this document.

E. Class III Summaries and Certifications

    22. Many comments argued that the statute only requires a ``class 
III summary'' to include information about the predicate device 
referenced in the 510(k), and not about the generic type of device. 
Another comment noted that a search for and summary of adverse safety 
and effectiveness data concerning a generic device type will yield 
substantial information that is not relevant to the 510(k) device or to 
its predicate device(s), because design and functional variations can 
make comparisons within an entire device type meaningless. These 
comments believed that FDA should limit the search and summary 
requirements to the device that is the subject of the 510(k) and its 
predicate device(s), as Congress intended.
    FDA disagrees with this interpretation of the statute. Section 
513(f)(3)(C) states that ``the manufacturer shall certify * * * that 
the manufacturer has conducted a reasonable search of all information 
known or otherwise available to the manufacturer respecting such other 
device and has included * * * a summary of and a citation to all 
adverse safety and effectiveness data respecting such other device * * 
*.'' FDA's requirement to include information concerning the ``type of 
device'' is consistent with the language in the statute which requires 
that ``all'' adverse safety and effectiveness data be submitted. 
Furthermore, determinations regarding substantial equivalence 
frequently require FDA to compare the safety and effectiveness 
information for a new 510(k) submission with the safety and 
effectiveness information concerning another device that has been found 
substantially equivalent through the 510(k) premarket notification 
process. (See 21 U.S.C. 360(i)(1)(A)). If the agency limited the scope 
of the class III summary only to information concerning the predicate 
chosen by the submitter, firms might fail to become aware of relevant 
safety and effectiveness problems associated with the type of the 
device they wish to market, including devices that have been found 
substantially equivalent. In addition, the agency might not obtain 
other information relevant to determining substantial equivalence.
    23. Many comments stated that Sec. 807.94 (21 CFR 807.94) requires 
the manufacturer to certify not only that he has conducted a reasonable 
search for adverse safety and effectiveness information, but also that 
he has absolutely included all such information in the summary. These 
comments pointed out that a manufacturer could never know with 
certainty that the information is complete or accurate, and therefore 
would become subject to new and personal criminal liability based on 
factors beyond his knowledge or control.
    In response to these concerns, the agency has modified Sec. 807.94 
to clarify that the class III certification is being made by the 
individual on behalf of the firm who submitted the 510(k) and that the 
class III summary is complete and accurate ``to the best of (the 
certifier's) knowledge.''

F. 21 CFR 807.95--Confidentiality of Information

    24. Many comments stated that FDA should revise the confidentiality 
section of the regulation to allow manufacturers to preserve the 
confidentiality of their 510(k) submission until the company is ready 
to begin marketing the device. These comments contended that this could 
be accomplished by granting manufacturers a provisional determination 
of substantial equivalence, leaving the final determination until the 
manufacturer is ready to market the device. One comment noted that, 
previously, a submitter provided certification and was able to maintain 
the confidentiality of its intention to market a device until such time 
as the device was actually ready to be commercialized. This comment 
further stated that the public disclosure of information about new 
devices as mandated by Congress is of potential importance only when a 
device is in a position to be marketed--a date which may be later than 
the 30 days after a determination of substantial equivalence has been 
made.
    Another comment noted that it is unlikely that a device 
manufacturer would make an early submission for a premarket 
notification if it knows that competitors might gain access to 
confidential product and marketing information. As a result, the 
premarket notification process would be lengthened because submitters 
would wait to make such submissions in order to prevent others from 
gaining a competitive edge. This comment asserted that even though the 
SMDA requires FDA to make certain information available about a 510(k) 
notification within 30 days of a substantial equivalence determination, 
this does not mean that confidentiality under Sec. 807.95(c) cannot be 
maintained.
    FDA acknowledges that, in the past, manufacturers could request 
that a 510(k) clearance remain confidential until the device was 
actually marketed. However, the agency can no longer provide such 
extended confidentiality because of the statutory requirement that 
510(k) summaries be available to the public within 30 days of the 
issuance of a determination that such device is substantially 
equivalent to another device. Even if the alternative suggested were 
more practical, the agency believes it lacks authority to extend this 
timeframe to the date a 510(k) submitter expects to begin marketing.

G. Procedures

    25. One comment suggested that FDA consider formalizing 
administrative procedures by which companies submit premarket 
notifications, by which FDA reviews original premarket notifications 
and subsequent amendments thereto, and by which substantial equivalence 
orders are issued. Another comment contended that the issuance of 
formal administrative procedures would significantly ``balance the 
playing field'' for FDA management, for FDA reviewers, and for 
industry.
    Administrative procedures are in place for submission, management, 
and review of premarket notifications. (See part 807 (21 CFR part 807) 
subpart E). FDA agrees that educational efforts concerning these 
procedures should be continued. The agency has issued numerous 
regulatory, guidance, and policy documents concerning premarket 
notifications and will continue to issue similar documents. These 
documents are available through the Center for Devices and Radiological 
Health's Division of Small Manufacturers Assistance. In addition, it is 
the agency's expectation that this final rule will further clarify the 
requirements for premarket notification 510(k) summaries and 510(k) 
statements.
    26. One comment requested FDA to provide an amendment process for 
510(k) summaries that would permit the submitter of a 510(k) summary to 
amend it at any point in the review of the 510(k) prior to FDA's 
determination of substantial equivalence.
    FDA will accept amendments to 510(k) summaries until such time as 
FDA makes a determination of substantial equivalence and has amended 
Sec. 807.92(a) to state this policy. Additionally, firms that elect to 
submit 510(k) statements at the time they file the premarket 
notification may change their minds and submit a 510(k) summary before 
the substantial equivalence determination is made. (See also response 
to paragraph 13 of this document).

H. Miscellaneous

    27. One comment from a manufacturer noted that, in the preamble to 
the interim rule, a change in material would be considered a 
significant difference for purposes of determining substantial 
equivalence (see 57 FR 18062 at 18063). The comment stated that not all 
changes in materials are ``significant.'' The comment further stated 
that the interim rule provided no guidance or formal procedures that 
would be applied to demonstrate equivalence or determine what 
constitutes a significant change. The comment contended that existing 
Sec. 807.87(g) appropriately addresses the issue of significant change.
    FDA agrees that there are existing regulations that address the 
definition of ``significant change.'' The agency believes that the 
criteria for a ``significant change'' are set forth in 
Sec. 807.81(a)(3) (21 CFR 807.81(a)(3)). In addition, examples of what 
constitutes a significant change, as well as a detailed discussion of 
FDA's decisionmaking process for 510(k) applications, is contained in 
``FDA's Guidance on the Premarket Notification Review Program'' and 
FDA's recent draft guidance, ``Deciding when to submit a 510(k) for a 
change to an existing device.'' These publications are available from 
the Division of Small Manufacturers Assistance, Center for Devices and 
Radiological Health (HFZ-220), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 800-638-2041 or 301-443-6597.
    The regulation that is the subject of this rulemaking is not 
intended to supplant current regulations and guidelines concerning 
significant change. The new regulation builds on existing regulations 
and guidance in order to implement the section of the SMDA that directs 
the Secretary to establish the requirements for 510(k) summaries under 
section 513(i)(3)(B) of the act.

I. Effective Date

    28. One comment stated that 60 days after date of publication is a 
reasonable effective date for the interim rule. Other comments argued 
that more time would be needed, particularly for companies who utilize 
the 510(k) statement and need to be in a position to comply with the 
30-day timeframe for responding to requestors.
    The agency is establishing a 90-day effective date after date of 
publication for all provisions in this rule, for the reasons discussed 
in paragraph 20 of this document.

III. Enforcement

    FDA emphasizes that it is the 510(k) submitter's responsibility to 
prepare adequate 510(k) summaries, or to respond appropriately to 
requests for information from the public when the submitter has chosen 
to submit a 510(k) statement. If FDA determines that a submitter of a 
510(k) summary or 510(k) statement has failed to comply properly with 
these regulations, FDA may provide the public with a purged copy of the 
510(k) submission prepared by agency staff. Under these circumstances, 
FDA would not follow predisclosure notification procedures established 
for responses to FOIA requests for 510(k) submissions. Failure to 
comply with the requirements established by section 513(i) of the SMDA 
is a prohibited act under section 301(q)(2) and (p) of the act, and the 
agency will use its enforcement powers to deter noncompliance. 
Violations under section 301 of the act may be subject to seizure or 
injunction pursuant to sections 302(a) and 304(a) of the act (21 U.S.C. 
332(a) and 334(a) respectively). In addition, a 510(k) submitter 
responsible for violating section 301 of the act may be subject to 
civil penalties under section 303(f) of the act (21 U.S.C. 333(f)) and 
criminal prosecution under section 303(a) of the act (21 U.S.C. 
333(a)).

IV. Environmental Impact

    The agency has determined under 21 CFR 25.24(e)(2) 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.

V. Analysis of Impacts

    An analysis of the costs and benefits of this regulation, conducted 
under Executive Order 12291, was discussed in the interim rule and the 
substance of that analysis has not changed. Executive Order 12291 has 
been superseded by Executive Order 12866.
    FDA has examined the impacts of the final 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 rule is consistent with the regulatory philosophy and principles 
identified in the Executive Order. In addition, the 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 provisions of the final rule, including the 
codification of the content requirements for 510(k) summaries, 510(k) 
statements, class III summaries, and class III certifications should 
assist submitters in organizing their submissions by giving submitters 
a framework for organizing the discussion of substantial equivalence. 
The regulation may be used as a checklist by submitters whenever they 
submit a 510(k) summary, a 510(k) statement, a class III summary, or a 
class III certification. This should result in better submissions and 
more efficient review. The costs of the rule will be spread among 
several thousand marketers in any year. For these reasons, the agency 
certifies that the 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.

VI. Paperwork Reduction Act of 1980

    Sections 807.87(h) and 807.87(i) of this final rule contain 
reporting requirements that were submitted for review and approval to 
the Director of the Office of Management and Budget (OMB), as required 
by section 3504(h) of the Paperwork Reduction Act of 1980. The 
requirements were approved and assigned OMB control number 0910-0281 
and are in conformance with the Paperwork Reduction Act of 1980 (44 
U.S.C. Ch. 35). The annual burden for reporting is as follows:

                                           Annual Burden for Reporting                                          
----------------------------------------------------------------------------------------------------------------
                                                      No. of                                                    
           CFR section                No. of       responses per   Total annual      Hours per      Total hours 
                                    respondents     respondent       responses       response                   
----------------------------------------------------------------------------------------------------------------
Summaries 807.87(h).............           1,645               1           1,645           23             37,835
Statements 807.87(h)............           3,055               1           3,055             .65           1,986
Citations 807.87(i).............             500               1             500           42             21,000
                                 -------------------------------------------------------------------------------
    Total.......................  ..............  ..............  ..............  ..............          60,821
----------------------------------------------------------------------------------------------------------------

List of Subjects in 21 CFR Part 807

    Confidential business information, Medical devices, Reporting and 
recordkeeping requirements.
    Therefore, under the Federal Food, Drug, and Cosmetic Act and under 
authority delegated to the Commissioner of Food and Drugs, the interim 
rule amending 21 CFR part 807, which published in the Federal Register 
of April 28, 1992 (57 FR 18062), and stayed at 57 FR 23059, is adopted 
effective March 14, 1995 as a final rule with the following changes:

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

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

    Authority: Secs. 301, 501, 502, 510, 513, 515, 519, 520, 701, 
704 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 331, 351, 
352, 360, 360c, 360e, 360i, 360j, 371, 374).

    2. Section 807.3 is amended by revising the first sentence of 
paragraph (n) and paragraphs (o) and (q) to read as follows:


Sec. 807.3  Definitions.

* * * * *
    (n) 510(k) summary (summary of any information respecting safety 
and effectiveness) means a summary, submitted under section 513(i) of 
the act, of the safety and effectiveness information contained in a 
premarket notification submission upon which a determination of 
substantial equivalence can be based * * *.
    (o) 510(k) statement means a statement, made under section 513(i) 
of the act, asserting that all information in a premarket notification 
submission regarding safety and effectiveness will be made available 
within 30 days of request by any person if the device described in the 
premarket notification submission is determined to be substantially 
equivalent. The information to be made available will be a duplicate of 
the premarket notification submission, including any adverse safety and 
effectiveness information, but excluding all patient identifiers, and 
trade secret or confidential commercial information, as defined in 
Sec. 20.61 of this chapter.
* * * * *
    (q) Class III summary means a summary of the types of safety and 
effectiveness problems associated with the type of device being 
compared and a citation to the information upon which the summary is 
based. The summary must be comprehensive and describe the problems to 
which the type of device is susceptible and the causes of such 
problems.
    3. Section 807.87 is amended by revising the first sentence of 
paragraph (i)(2) and paragraph (j), and by adding a parenthetical 
statement at the end of the section to read as follows:


Sec. 807.87  Information required in a premarket notification 
submission.

* * * * *
    (i) * * *
    (2) For which no final regulation requiring premarket approval has 
been issued under section 515(b) of the act, a summary of the types of 
safety and effectiveness problems associated with the type of devices 
being compared and a citation to the information upon which the summary 
is based (class III summary). * * *
    (j) A statement that the submitter believes, to the best of his or 
her knowledge, that all data and information submitted in the premarket 
notification are truthful and accurate and that no material fact has 
been omitted.
* * * * *
(Information collection requirements in this section were approved 
by the Office of Management and Budget (OMB) and assigned OMB 
control number 0910-0281)

    4. Section 807.92 is amended by revising the introductory text of 
paragraph (a), paragraphs (a)(3), (a)(4), (a)(5), (a)(6), (b), and by 
adding new paragraph (d) to read as follows:


Sec. 807.92  Content and format of a 510(k) summary.

    (a) A 510(k) summary shall be in sufficient detail to provide an 
understanding of the basis for a determination of substantial 
equivalence. FDA will accept summaries as well as amendments thereto 
until such time as FDA issues a determination of substantial 
equivalence. All 510(k) summaries shall contain the following 
information:
* * * * *
    (3) An identification of the legally marketed device to which the 
submitter claims equivalence. A legally marketed device to which a new 
device may be compared for a determination regarding substantial 
equivalence is a device that was legally marketed prior to May 28, 
1976, or a device which has been reclassified from class III to class 
II or I (the predicate), or a device which has been found to be 
substantially equivalent through the 510(k) premarket notification 
process;
    (4) A description of the device that is the subject of the 
premarket notification submission, such as might be found in the 
labeling or promotional material for the device, including an 
explanation of how the device functions, the scientific concepts that 
form the basis for the device, and the significant physical and 
performance characteristics of the device, such as device design, 
material used, and physical properties;
    (5) A statement of the intended use of the device that is the 
subject of the premarket notification submission, including a general 
description of the diseases or conditions that the device will 
diagnose, treat, prevent, cure, or mitigate, including a description, 
where appropriate, of the patient population for which the device is 
intended. If the indication statements are different from those of the 
legally marketed device identified in paragraph (a)(3) of this section, 
the 510(k) summary shall contain an explanation as to why the 
differences are not critical to the intended therapeutic, diagnostic, 
prosthetic, or surgical use of the device, and why the differences do 
not affect the safety and effectiveness of the device when used as 
labeled; and
    (6) If the device has the same technological characteristics (i.e., 
design, material, chemical composition, energy source) as the predicate 
device identified in paragraph (a)(3) of this section, a summary of the 
technological characteristics of the new device in comparison to those 
of the predicate device. If the device has different technological 
characteristics from the predicate device, a summary of how the 
technological characteristics of the device compare to a legally 
marketed device identified in paragraph (a)(3) of this section.
    (b) 510(k) summaries for those premarket submissions in which a 
determination of substantial equivalence is also based on an assessment 
of performance data shall contain the following information:
    (1) A brief discussion of the nonclinical tests submitted, 
referenced, or relied on in the premarket notification submission for a 
determination of substantial equivalence;
    (2) A brief discussion of the clinical tests submitted, referenced, 
or relied on in the premarket notification submission for a 
determination of substantial equivalence. This discussion shall 
include, where applicable, a description of the subjects upon whom the 
device was tested, a discussion of the safety or effectiveness data 
obtained from the testing, with specific reference to adverse effects 
and complications, and any other information from the clinical testing 
relevant to a determination of substantial equivalence; and
    (3) The conclusions drawn from the nonclinical and clinical tests 
that demonstrate that the device is as safe, as effective, and performs 
as well as or better than the legally marketed device identified in 
paragraph (a)(3) of this section.
* * * * *
    (d) Any other information reasonably deemed necessary by the 
agency.
    5. Section 807.93 is revised to read as follows:


Sec. 807.93  Content and format of a 510(k) statement.

    (a)(1) A 510(k) statement submitted as part of a premarket 
notification shall state as follows:

    I certify that, in my capacity as (the position held in company 
by person required to submit the premarket notification, preferably 
the official correspondent in the firm), of (company name), I will 
make available all information included in this premarket 
notification on safety and effectiveness within 30 days of request 
by any person if the device described in the premarket notification 
submission is determined to be substantially equivalent. The 
information I agree to make available will be a duplicate of the 
premarket notification submission, including any adverse safety and 
effectiveness information, but excluding all patient identifiers, 
and trade secret and confidential commercial information, as defined 
in 21 CFR 20.61.

    (2) The statement in paragraph (a)(1) of this section should be 
signed by the certifier, made on a separate page of the premarket 
notification submission, and clearly identified as ``510(k) 
statement.''
    (b) All requests for information included in paragraph (a) of this 
section shall be made in writing to the certifier, whose name will be 
published by FDA on the list of premarket notification submissions for 
which substantial equivalence determinations have been made.
    (c) The information provided to requestors will be a duplicate of 
the premarket notification submission, including any adverse 
information, but excluding all patient identifiers, and trade secret 
and confidential commercial information as defined in Sec. 20.61 of 
this chapter.
    6. Section 807.94 is revised to read as follows:


Sec. 807.94  Format of a class III certification.

    (a) A class III certification submitted as part of a premarket 
notification shall state as follows:

    I certify, in my capacity as (position held in company), of 
(company name), that I have conducted a reasonable search of all 
information known or otherwise available about the types and causes 
of safety or effectiveness problems that have been reported for the 
(type of device). I further certify that I am aware of the types of 
problems to which the (type of device) is susceptible and that, to 
the best of my knowledge, the following summary of the types and 
causes of safety or effectiveness problems about the (type of 
device) is complete and accurate.

    (b) The statement in paragraph (a) of this section should be signed 
by the certifier, clearly identified as ``class III certification,'' 
and included at the beginning of the section of the premarket 
notification submission that sets forth the class III summary.
    7. Section 807.95 is amended by revising paragraph (d) to read as 
follows:


Sec. 807.95  Confidentiality of information.

* * * * *
    (d) FDA will make a 510(k) summary of the safety and effectiveness 
data available to the public within 30 days of the issuance of a 
determination that the device is substantially equivalent to another 
device. Accordingly, even when a 510(k) submitter has complied with the 
conditions set forth in paragraphs (b) and (c) of this section, 
confidentiality for a premarket notification submission cannot be 
granted beyond 30 days after FDA issues a determination of equivalency.
* * * * *
    Dated: November 30, 1994.
William K. Hubbard,
Interim Deputy Commissioner for Policy.
[FR Doc. 94-30422 Filed 12-13-94; 8:45 am]
BILLING CODE 4160-01-P