I

104TH CONGRESS

2D SESSION H. R. 3201

To amend the Federal Food, Drug, and Cosmetic Act to facilitate the development, clearance, and use of devices to maintain and improve the public

health and quality of life of the citizens of the United States.

IN THE HOUSE OF REPRESENTATIVES

MARCH 29, 1996

Mr. BARTON of Texas (for himself, Mr. GREENWOOD, Mr. RICHARDSON, Mr.

BILIRAKIS, Mr. HALL of Texas, Mr. GORDON, Mr. BURR, Ms. ESHOO,

Mr. COBURN, Mr. BREWSTER, Mr. KLUG, Mr. DOOLEY of California, Mr.

GANSKE, Mr. MCHALE, Mr. BILBRAY, Mr. PAYNE of Virginia, Mr.

OXLEY, Mr. HOLDEN, Mr. FIELDS of Texas, Mr. PAXON, Mr. SCHAEFER,

Mr. TAUZIN, Mr. FOX of Pennsylvania, Mr. UPTON, Mr. CAMPBELL, Mr.

MCINTOSH, Mr. COX of California, Mr. DREIER, Mr. HEINEMAN, Mr.

FUNDERBURK, Mr. WELDON of Florida, Mr. HOSTETTLER, Mr. SHAYS,

Mr. HASTERT, Mr. NORWOOD, Mr. BURTON of Indiana, Mr. FRAZER,

Mr. STEARNS, Mr. FRISA, Mr. RAMSTAD, Mr. MARTINI, and Ms. DUNN

of Washington) introduced the following bill; which was referred to the

Committee on Commerce

A BILL

To amend the Federal Food, Drug, and Cosmetic Act to

facilitate the development, clearance, and use of devices

to maintain and improve the public health and quality

of life of the citizens of the United States.

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled,
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1 SECTION 1. SHORT TITLE; REFERENCE; TABLE OF CON2 TENTS.

3 (a) SHORT TITLE.—This Act may be cited as the

4 ‘‘Medical Device Reform Act of 1996’’.

5 (b) REFERENCE.—Whenever in this Act an amend6 ment or repeal is expressed in terms of an amendment

7 to, or repeal of, a section or other provision, the reference

8 shall be considered to be made to a section or other provi9 sion of the Federal Food, Drug, and Cosmetic Act (21

10 U.S.C. 301 et seq.).

11 (c) TABLE OF CONTENTS.—The table of contents is

12 as follows:

Sec. 1. Short title; reference; table of contents.

Sec. 2. FDA mission and annual report.

Sec. 3. Dispute resolution.

Sec. 4. Investigational device exemptions.

Sec. 5. Special review for certain devices.

Sec. 6. Expanding humanitarian use of devices.

Sec. 7. Performance standards.

Sec. 8. Effectiveness determination.

Sec. 9. Premarket notification.

Sec. 10. Classification panels.

Sec. 11. Premarket approval.

Sec. 12. Accreditation of third parties.

Sec. 13. Reclassification of preamendment devices.

Sec. 14. Device tracking.

Sec. 15. Postmarket surveillance.

Sec. 16. Harmonization.

Sec. 17. Good manufacturing practice inspections.

Sec. 18. Use of scientific and medical information.

Sec. 19. Reports.

Sec. 20. G.M.P. and device reports.

Sec. 21. Civil penalties.

Sec. 22. Information system.

Sec. 23. Environmental impact review.

Sec. 24. Informal agency statements.

Sec. 25. Research and education; practice of medicine.

Sec. 26. Publication of notice of deviation.
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1 SEC. 2. FDA MISSION AND ANNUAL REPORT.

2 (a) MISSION.—Section 903 (21 U.S.C. 393) is

3 amended by redesignating subsections (b) and (c) as sub4 sections (c) and (d), respectively, and by adding after sub5 section (a) the following:

6 ‘‘(b) MISSION.—The Food and Drug Administration

7 shall protect the public health and safety and promptly

8 and efficiently review and approve clinical research and

9 marketing of products in a manner that does not unduly

10 impede innovation or product availability. The Food and

11 Drug Administration shall participate with other countries

12 to reduce the burden of regulation, harmonize regulatory

13 requirements, and achieve appropriate reciprocal arrange14 ments.’’

15 (b) ANNUAL REPORT.—Section 903 (21 U.S.C. 393),

16 as amended by subsection (a), is amended by adding at

17 the end the following:

18 ‘‘(e) ANNUAL REPORT.—The Secretary shall, simul19 taneously with the submission each year of the budget for

20 the Food and Drug Administration, submit to the Com21 mittee on Commerce of the House of Representatives and

22 the Committee on Labor and Human Resources of the

23 Senate an annual report which shall—

24 ‘‘(1) review the performance of the Food and

25 Drug Administration in meeting its mission and the
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1 development of Food and Drug Administration poli2 cies to implement such mission;

3 ‘‘(2) review the performance of the Food and

4 Drug Administration in meeting its own perform5 ance standards, including its own outcome measure6 ments and statutory deadlines for the approval of

7 products or for other purposes contained in this Act;

8 ‘‘(3) describe the staffing and resources of the

9 Food and Drug Administration and list those per10 sons and organizations accredited to conduct inves11 tigations under section 505(1), product approvals

12 under sections 505 and 506, and to perform good

13 manufacturing practice reviews under section

14 505(d)(3) and 520(f);

15 ‘‘(4) describe the goals, activities, and accom16 plishments of the Food and Drug Administration in

17 bilateral and multinational meetings that addressed

18 methods and approaches to reduce the burden of

19 regulation, harmonize regulation, and to seek appro20 priate reciprocal arrangements, list each such meet21 ing, and list pending issues specifying those that are

22 not consistent with or are contrary to the provisions

23 of this Act; and

24 ‘‘(5) compare the performance of the Food and

25 Drug Administration in approving innovative prod-
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1 ucts with that of the most successful agencies per2 forming similar functions in other countries and

3 compare the resources used by such agencies.’’.

4 SEC. 3. DISPUTE RESOLUTION.

5 Chapter V is amended by adding after section 522

6 the following:

7 ‘‘DISPUTE RESOLUTION

8 ‘‘SEC. 523. (a) At any time before the issuance of

9 the notice under section 510(k) or an exemption for inves10 tigational use under section 520(g) for a device, the appli11 cant may, in writing, notify the Secretary that an impasse

12 exists in the review of the application for a device under

13 section 515 or the submission for such an exemption with

14 respect to a specifically identified issue.

15 ‘‘(b) On receipt of the notification from the applicant,

16 the Secretary shall refer the disputed issue—

17 ‘‘(1) to an existing (as of the date of the notifi18 cation) scientific advisory panel having expertise re19 lated to the issue;

20 ‘‘(2) to a special Government employee, as de21 fined in section 202(a) of title 18, United States

22 Code, or to a non-governmental person qualified to

23 mediate or arbitrate the substance of such impasse

24 who is acceptable to the Secretary and the applicant.

25 ‘‘(c) The applicant and representatives of the Sec26 retary may consult with the panel, special Government em-
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1 ployee, or non-governmental person on the matter re2 ferred. The panel, special Governmental employee, or non3 governmental person shall submit to the Secretary and the

4 applicant a report containing recommendations (including

5 a statement of reasons for the recommendations) regard6 ing the matter not later than 60 days after the date of

7 the referral, or not later than 90 days after the date of

8 the referral if the panel, special Governmental employee,

9 or non-governmental person considers the additional 30

10 days to be necessary. Not later than 30 days after the

11 date of receiving the report, the Secretary shall, in writing,

12 confirm or modify the recommendations received, provid13 ing reasons and reference to data before the panel, special

14 Governmental employee, or non-governmental person for

15 any modification. If the Secretary fails to act on such a

16 recommendation within 30 days of its receipt, the rec17 ommendation of the panel, special Government employee,

18 or non-governmental person shall be deemed to be the rec19 ommendation of the Secretary.

20 ‘‘(d) The Federal Advisory Committee Act shall not

21 apply to any scientific advisory panel acting under this

22 section.’’.

23 SEC. 4. INVESTIGATIONAL DEVICE EXEMPTIONS.

24 Section 520(g) (21 U.S.C. 360j(g)) is amended by

25 adding at the end the following:
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1 ‘‘(6) The Secretary shall, by regulation and within

2 120 days of the date of the enactment of this paragraph,

3 update the procedures and conditions under which devices

4 intended for human use may upon application be granted

5 an exemption from certain requirements of this Act. Such

6 regulation shall—

7 ‘‘(A) permit the use of investigational devices,

8 outside of an investigational protocol, in the diag9 nosis or treatment of diseases or conditions that are

10 life-threatening or could be irreversibly debilitating

11 when the risk of not using the investigational device

12 exceeds the probable risk of using such device as de13 termined by the treating physician;

14 ‘‘(B) ensure that prior to submitting an appli15 cation to the Secretary or to an institutional review

16 board, any person intending to investigate the safety

17 or effectiveness of a class III device or an implant

18 device will have the opportunity to submit an inves19 tigational plan, including a clinical protocol, to the

20 Secretary for review;

21 ‘‘(C) within 30 days of receipt of an investiga22 tional plan under subparagraph (B), require the Sec23 retary to respond in writing to the submitter identi24 fying each deficiency with the plan and such other
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1 information that will facilitate the review and ap2 proval of an application;

3 ‘‘(D) provide a submitter who disputes the Sec4 retary’s response under subparagraph (C) a right to

5 appear before a classification panel constituted

6 under section 513(b), at the next scheduled panel

7 meeting, and obtain the review by the panel of the

8 investigational plan and the Secretary’s evaluation of

9 such plan;

10 ‘‘(E) permit developmental changes in devices

11 in response to information gathered during the

12 course of an investigation without requiring an addi13 tional approval of an application for an investiga14 tional device exemption, or the approval of a supple15 ment to such an application, if such changes do not

16 constitute a significant change in design or a signifi17 cant change in basic principles of operation; and

18 ‘‘(F) without additional approval of an applica19 tion for an investigational device exemption, or the

20 approval of a supplement to such an application,

21 permit changes or modifications to clinical protocols

22 that do not affect the validity of data or information

23 resulting from the completion of an approved proto24 col and do not alter the relationship of likely patient

25 risk to benefit relied upon to approve a protocol.’’.
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1 SEC. 5. SPECIAL REVIEW FOR CERTAIN DEVICES.

2 Section 515(d) is amended by adding at the end the

3 following:

4 ‘‘(4) In order to better treat or diagnose life-threaten5 ing or irreversibly debilitating diseases or conditions of

6 man, the Secretary shall promulgate a regulation to create

7 review priority for devices—

8 ‘‘(A) representing breakthrough technologies,

9 ‘‘(B) for which no approved alternatives exist,

10 ‘‘(C) which offer significant advantages over ex11 isting approved alternatives, or

12 ‘‘(D) the availability of which is in the best in13 terest of the public health.

14 Such regulation shall include, among other things, criteria

15 identifying devices which merit preferential review, speci16 fying procedures for implementing such reviews, and iden17 tifying substantive review criteria appropriate to making

18 prompt and efficient review of such devices. The Secretary

19 shall publish in the Federal Register a proposed regulation

20 to create such review priority no later than 6 month after

21 the date of the enactment of this paragraph, allowing 60

22 days for comment. The Secretary will publish a final regu23 lation no later than 60 days after the last day of the com24 ment period.’’.

25 SEC. 6. EXPANDING HUMANITARIAN USE OF DEVICES.

26 Section 520(m) (21 U.S.C. 360j(m)) is amended—
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1 (1) in paragraph (2), by inserting after and

2 below subparagraph (C) the following: ‘‘The request

3 shall be in the form of an application to the Sec4 retary. Within 30 days of the date of the receipt of

5 an application, the Secretary shall issue an order ap6 proving or denying the application.’’; and

7 (2) by striking paragraphs (5) and (6).

8 SEC. 7. PERFORMANCE STANDARDS.

9 Section 514 (21 U.S.C. 360d) is amended to read as

10 follows:

11 ‘‘STANDARDS

12 ‘‘SEC. 514. (a) The Secretary shall, through publica13 tion in the Federal Register, issue notices recognizing ap14 plicable nationally or internationally recognized consensus

15 standards in any determination as to whether there is a

16 reasonable assurance that a device is safe or effective or

17 to determine compliance with any requirement of this Act.

18 Any person may elect to utilize data other than that re19 quired by such standards to demonstrate a reasonable as20 surance of device safety or effectiveness or compliance

21 with the requirements of this Act.

22 ‘‘(b) The Secretary shall accept certifications that de23 vices conform with each type of standard referenced in

24 subsection (a) and identified in each such certification.’’.
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1 SEC. 8. EFFECTIVENESS DETERMINATION.

2 Section 513(a)(3) (21 U.S.C. 360c(a)(3)) is amend3 ed—

4 (1) in subparagraph (A), by inserting ‘‘one or

5 more’’ after ‘‘on the basis of’’ and by striking ‘‘clini6 cal investigations’’ and inserting ‘‘a clinical inves7 tigation’’; and

8 (2) by adding at the end of subparagraph (A)

9 the following: ‘‘A well-controlled clinical investiga10 tion—

11 ‘‘(i) shall not be considered appropriate unless

12 the Secretary determines, after consultation with a

13 classification panel established under subsection (b),

14 that such investigation is necessary to demonstrate

15 that the device will have the effect it purports or is

16 represented to have under the conditions of use pre17 scribed, recommended, or suggested in the labeling

18 of the device; and

19 ‘‘(ii) shall only include methods of control that

20 are appropriate to the disease or condition for which

21 a device is intended as prescribed, recommended, or

22 suggested in the labeling of the device.

23 Any person may submit a well-controlled clinical investiga24 tion to the Secretary to demonstrate that a device will

25 have the effect it purports or is represented to have under

26 the conditions of use prescribed, recommended, or sug-
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1 gested in the labeling of the device and, without reliance

2 on a classification panel, the Secretary may determine that

3 such studies are appropriate for such purpose.’’; and

4 (3) by adding at the end the following:

5 ‘‘(C) For purposes of this paragraph, the determina6 tion of effectiveness shall not include any of the following:

7 ‘‘(i) The evaluation of clinical outcomes if the

8 use of a device provides a medical contribution to

9 the diagnosis or treatment of the persons for whom

10 the device is intended unless the labeling of the de11 vice represents that it provides a therapeutic effect

12 to the persons for whom the device is intended.

13 ‘‘(ii) The evaluation of relative effectiveness un14 less the performance of a device is compared to that

15 of another device through labeling or other represen16 tations by the person legally responsible for the la17 beling of the device.

18 ‘‘(iii) The evaluation of cost effectiveness rep19 resentations unless the labeling specifically includes

20 a statement about the cost effectiveness.

21 ‘‘(iv) The evaluation of any indication for use

22 not included in the labeling of a device unless the

23 person legally responsible for the labeling of the de24 vice promotes such indications for use.’’.
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1 SEC. 9. PREMARKET NOTIFICATION.

2 (a) SECTION 510.—Section 510 (21 U.S.C. 360) is

3 amended—

4 (1) in subsection (k), by inserting after ‘‘a de5 vice intended for human use’’ the following: ‘‘(other

6 than any device classified into class I under section

7 513 or 520 or any device classified into class II

8 under section 513 or 520 if such class II device has

9 been exempted from the requirements of this sub10 section under subsection (l))’’;

11 (2) in subsection (k), by striking ‘‘report to the

12 Secretary’’ and inserting ‘‘have the option of report13 ing to the Secretary or any person who is not an em14 ployee of the United States and who is accredited

15 under section 712(a)’’; and

16 (3) by adding the following after subsection (k):

17 ‘‘(l) Within 30 days after the date of the enactment

18 of this subsection, the Secretary shall publish in the Fed19 eral Register a list of each type of class II device that

20 does not require a report under subsection (k) to provide

21 reasonable assurance of safety and effectiveness. Each

22 type of class II device listed by the Secretary shall be ex23 empt from the requirement to file a report under sub24 section (k) as of the date of the publication of the list

25 in the Federal Register. Beginning on the date that is 1

26 day after the date of the publication of the list, any person
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1 may petition the Secretary to exempt a type of class II

2 device from the reporting requirement of subsection (k).

3 If the Secretary fails to respond to a petition within 120

4 days of receiving it, the petition shall be deemed to be

5 granted.’’.

6 (b) INITIAL CLASSIFICATION.—Section 513(f) (21

7 U.S.C. 360c(f)) is amended—

8 (1) in the second sentence of paragraph (1) by

9 striking the period at the end and inserting the fol10 lowing: ‘‘unless within 30 days of receiving an order

11 classifying the device into class III the individual

12 who submits a report under section 510(k) for such

13 device requests review and recommendation with re14 spect to the classification of the device by a classi15 fication panel established under subsection (b) and

16 a final order of classification from the Secretary.

17 After the request, a device classified into class III

18 under this paragraph shall not be deemed to be fi19 nally classified until a classification panel established

20 under subsection (b) reviews the request with re21 spect to the classification of the device and, within

22 60 days of the date of receiving the request, rec23 ommends to the Secretary a classification for the de24 vice based on the classification criteria set forth in

25 subparagraphs (A) through (C) of subsection (a)(1).
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1 Thereafter, the Secretary shall have 10 days to de2 termine by order the final classification of the device

3 by applying such criteria. If the Secretary fails to

4 issue such an order within such 10 days, the rec5 ommendation of the classification panel shall be

6 deemed to be the order of final classification of the

7 device issued by the Secretary.’’.

8 (2) by adding at the end the following:

9 ‘‘(4)(A) Within 90 days of receiving a report required

10 under section 510(k) for devices identified as being sub11 stantially equivalent to a class II device, a person accred12 ited under section 712 to conduct reviews of such report

13 shall determine the initial classification under paragraph

14 (1)(A) of any such device which was not introduced or de15 livered for introduction into interstate commerce for com16 mercial distribution before the date of the enactment of

17 this subparagraph and shall submit such determination to

18 the Secretary. The accredited person shall immediately, by

19 registered mail, provide to the submitter of such report

20 a copy of the recommendation to the Secretary for an

21 order classifying the device. Such determination shall be

22 considered to be an order of the Secretary initially

23 classifying the device. If the accredited person determines

24 that the device should be classified into class III, such per-
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1 son shall, immediately upon making such determination,

2 refer the report to the Secretary.

3 ‘‘(B) Within 60 days of receiving a report required

4 under section 510(k) for a device identified as being sub5 stantially equivalent to a class III device, a person accred6 ited under section 712 to conduct reviews of such report

7 shall make a determination of the initial classification

8 under paragraph (1)(A) of any such device which was not

9 introduced or delivered for introduction into interstate

10 commerce for commercial distribution before the date of

11 the enactment of this subparagraph, and within such time

12 period submit a recommendation to the Secretary and to

13 the submitter of the report which contains such deter14 mination. The recommendation by such person of initial

15 classification of a device shall be considered to be an order

16 of the Secretary unless the Secretary, within 30 calendar

17 days of receipt of the recommendation, finds that the de18 vice is not substantially equivalent to a predicate device

19 and issues an order under this subsection initially

20 classifying the device. Such order shall be based on the

21 criteria in this subsection and subsection (i) and provide

22 a detailed explanation and justification for the basis of the

23 Secretary’s disagreement, if any, with the accredited per24 son’s recommendation. If, within 90 days from the date

25 of receipt of the report, the Secretary does not issue an
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1 order that differs from the recommendation of the accred2 ited person, the Secretary shall promptly send by reg3 istered mail to the submitter of the report such rec4 ommendation as the Secretary’s order of initial classifica5 tion. If the Secretary does not provide the submitter such

6 recommendation by registered mail as specified, the rec7 ommendation of classification provided to the submitter

8 of the report shall become the Secretary’s order of initial

9 classification of the device. Such classification may only

10 be changed pursuant to the procedures specified in para11 graph (2) of this subsection.

12 ‘‘(5) the Secretary may not withhold a determination

13 of the initial classification of a device under paragraph (1)

14 because of a failure to comply with any provision of this

15 Act unrelated to a substantial equivalence decision, includ16 ing a finding that the facility in which the device is manu17 factured is not in compliance with good manufacturing re18 quirements as set forth in regulations of the Secretary

19 under section 520(f).’’.

20 (c) SECTION 513(i).—Section 513(i) (21 U.S.C.

21 360c(i)) is amended—

22 (1) in paragraph (1)(A)(ii)(I), by striking ‘‘clin23 ical data’’ and inserting ‘‘either appropriate clinical

24 or scientific data’’ and by inserting ‘‘or a person ac25 credited under section 712’’ after ‘‘Secretary’’;
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1 (2) in paragraph (1)(A)(ii)(II), by striking ‘‘ef2 ficacy’’ and inserting ‘‘effectiveness’’; and

3 (3) by adding at the end of paragraph (1) the

4 following:

5 ‘‘(C) For purposes of subparagraph (A), the term ‘le6 gally marketed device’ includes any device introduced into

7 interstate commerce for commercial distribution before

8 May 28, 1976, and any device found substantially equiva9 lent to such device, which has not been removed from the

10 market by an order of the Secretary or a judicial order

11 because it is unsafe or ineffective.

12 ‘‘(D) Any change or modification to a device, other

13 than a major change (including any major modification)

14 in the intended use, shall not require an additional submis15 sion under section 510(k) if such change or modification

16 is supported by appropriate data or information and the

17 change or modification can be shown to not adversely af18 fect the safety or effectiveness of the device which was in19 troduced in interstate commerce before May 28, 1976 or

20 initially classified under subsection (f). All data or infor21 mation relied upon to document that a change to (includ22 ing any modification of) such a device does not require

23 an additional report under section 510(k) shall be made

24 available to the Secretary upon request and maintained
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1 for a period of time equal to at least the commercial life

2 of the device.

3 ‘‘(E) For the purpose of determining the intended use

4 of a predicate device under subparagraph (A), each use

5 reasonably included within a general use for the predicate

6 device shall be deemed a legally marketed use of the predi7 cate device and shall be available for use in premarket re8 ports required under section 510(k).

9 ‘‘(F) For the purpose of determining substantial

10 equivalence, the Secretary shall not consider any uses or

11 indications for use of a device that are not specifically

12 identified in a premarket market notification under section

13 510(k).

14 ‘‘(G) For the purpose of determining substantial

15 equivalence the Secretary shall accept certification of com16 pliance with nationally or internationally recognized con17 sensus standards to resolve any substantial equivalence

18 issue which such standards address. To the extent that

19 a substantial equivalence issue is resolved by such stand20 ards, additional information shall not be required to fur21 ther address such an issue.’’.

22 SEC. 10. CLASSIFICATION PANELS.

23 Section 513(b) (21 U.S.C. 360c(b)) is amended by

24 adding at the end the following:
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1 ‘‘(5) Classification panels covering each type of device

2 shall be scheduled to meet at least 6 times each calendar

3 year to consider, among other things, the approval of ap4 plications submitted to the Secretary under section 515.

5 Such meetings shall, to the extent possible, be scheduled

6 at equal intervals throughout the year. Such meetings

7 shall be held with the physical presence of panel members

8 at least 3 times each calendar year. Other meetings of the

9 panel may be held using electronic communication to con10 vene the meeting.

11 ‘‘(6) Each member of a panel shall publically disclose

12 all conflicts of interest that member may have with the

13 work to be undertaken by the panel. No member of a panel

14 may vote on any matter where the member could gain fi15 nancially from the advice given to the Secretary. The Sec16 retary may grant a waiver of any conflict of interest upon

17 public disclosure of such conflict of interest if such waiver

18 contributes to the ability of a panel to contribute to the

19 public health, except that the Secretary may not grant a

20 waiver for a member of a panel when the member’s own

21 scientific work is involved.

22 ‘‘(7) The Secretary shall provide education and train23 ing to each new panel member before such member partici24 pates in a panel’s activities. Such education and training

25 shall include a familiarization with certain requirements
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1 under this Act and any related regulation of the Secretary

2 and the administrative process and procedures related to

3 panel meetings.

4 ‘‘(8) The Secretary shall take whatever action is nec5 essary to ensure that regular meetings are held by sci6 entific advisory panels, at appropriate intervals and for a

7 sufficient length of time, so that any matter to be reviewed

8 by any such panel shall be presented to the panel not more

9 than 60 days after the matter is ready for review by the

10 panel. The meetings shall occur not less than 6 times each

11 year unless there are compelling reasons for fewer meet12 ings. Such meetings shall be held with the physical pres13 ence of panel members at least 3 times each calendar year.

14 Other meetings of the panel may be held using electronic

15 communication to convene the meeting.

16 ‘‘(9)(A) All persons, including employees of the Sec17 retary, shall have the same rights and responsibilities re18 garding—

19 ‘‘(i) the submission of data and information to,

20 and contact and discussion with, a classification

21 panel;

22 ‘‘(ii) the participation of the persons at meet23 ings of the panel; and

24 ‘‘(iii) access to data and information submitted

25 to a classification panel (except for data and infor-
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1 mation that are not available for public disclosure

2 under section 552 of title 5, United States Code).

3 ‘‘(B) In a case in which a classification panel reviews

4 a submission under section 510(k), all related data and

5 information that are not available for public disclosure

6 under section 552 of title 5, United States Code, shall be

7 exchanged between the person who submitted such notice

8 and the Food and Drug Administration at the time the

9 data and information are submitted to such panel but

10 shall not otherwise be publicly disclosed.

11 ‘‘(C) Any meetings of a classification panel shall pro12 vide adequate time for initial presentations and for re13 sponse to any differing views and shall encourage free and

14 open participation by all interested persons.

15 ‘‘(10) Within 30 days after the date a classification

16 panel makes its conclusions and recommendations on any

17 matter under review by the panel, the Food and Drug Ad18 ministration official responsible for the matter shall review

19 the conclusions and recommendations of the panel, shall

20 make a final decision on the matter, and shall notify the

21 affected persons of the decision in writing and, if the deci22 sion differs from the conclusions and recommendations of

23 the panel, shall include the reasons for the difference.

24 ‘‘(11) A scientific advisory panel under this sub25 section shall not be subject to the annual chartering and
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1 annual report requirements of the Federal Advisory Com2 mittee Act. Such a panel shall make an annual report of

3 its activities to the Secretary.’’.

4 SEC. 11. PREMARKET APPROVAL.

5 (a) SECTION 515(c).—Section 515(c) (21 U.S.C.

6 360e(c)) is amended—

7 (1) in the first sentence of paragraph (1), by

8 inserting immediately before the period the follow9 ing: ‘‘or may file such application with a person au10 thorized to review applications for premarket ap11 proval under section 712’’; and

12 (2) by adding after paragraph (2) the following:

13 ‘‘(3)(A) The scope of review responsibilities of accred14 ited persons authorized to conduct reviews of premarket

15 approval applications under section 712 shall include—

16 ‘‘(i) the receipt and filing of applications for

17 substantive review;

18 ‘‘(ii) the review of applications to determine

19 whether there is a reasonable assurance that a de20 vice is safe and effective for its labeled uses;

21 ‘‘(iii) the review of applications in accordance

22 with the schedule for review identified in subsection

23 (d)(2) unless such organization or person by con24 tract with an applicant alters such schedule or elimi-
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1 nates any item of review but not the review by a

2 classification panel under paragraph (2);

3 ‘‘(iv) the presentation, when appropriate, of

4 such applications to a classification panel constituted

5 under section 513(b); and

6 ‘‘(v) the evaluation of classification panel rec7 ommendations and premarket approval applications

8 and the formulation of reports and recommendations

9 to be submitted to the Secretary no later than 30

10 days after receipt of a classification panel’s rec11 ommendation.

12 Recommendations to the Secretary shall specify whether

13 an application should be approved or denied and shall

14 state the basis for the recommendation.

15 ‘‘(B) The recommendation of an accredited person to

16 approve or deny an application shall be considered to be

17 an order of the Secretary unless the Secretary finds that

18 there is a reasonable probability that the device is not safe

19 or effective. In the event that the Secretary makes such

20 a finding, the Secretary shall provide a detailed expla21 nation of the basis of the finding.’’.

22 (b) SECTION 515(d).—Section 515(d) (21 U.S.C.

23 360e(d)) is amended by redesignating paragraphs (2) and

24 (3) as paragraphs (5) and (6), respectively, by adding be25 fore the semicolon at the end of paragraph (5)(B) (as so
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1 redesignated) the following: ‘‘and for purposes of this sub2 paragraph, the determination of a reasonable assurance

3 that a device is effective under the conditions of use pre4 scribed, recommended, or suggested in proposed labeling

5 shall not include uses or indications for use not identified

6 in the application’’, and by adding after paragraph (1) the

7 following:

8 ‘‘(2) Each application received under subsection (c)

9 shall be reviewed in the following manner to achieve final

10 action on such applications within 180 days of its receipt:

11 ‘‘(A) The Secretary shall determine, within 30

12 days of the receipt of an application submitted under

13 subsection (c), whether the application satisfies the

14 content requirements of subsection (c)(1) and appli15 cable regulations.

16 ‘‘(B) The Secretary shall meet with an appli17 cant on request within 90 days of receipt of an ap18 plication that has been accepted for filing to discuss

19 the review status of the application. If the applica20 tion does not appear in a form that would neces21 sitate an approval under this subsection, the Sec22 retary shall, in writing and prior to the meeting,

23 present to the applicant a description of any defi24 ciencies with the application and what information
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1 would be necessary to bring the application into a

2 form that would require an approval.

3 ‘‘(C) The Secretary shall refer an application to

4 a classification panel established under section 513

5 for review and an approval recommendation, unless

6 a panel is not required under subsection (c)(2), with7 in 30 days of the meeting referred to in subpara8 graph (B). The application shall be reviewed at the

9 next scheduled panel meeting.

10 ‘‘(D) The Secretary shall, within 15 days before

11 the date of a panel review, provide to an applicant

12 a statement of each view or position the Secretary

13 has communicated or intends to communicate to a

14 classification panel constituted under section 513(b)

15 or any panel member regarding a premarket ap16 proval application scheduled for a panel review. Ad17 ditionally, at this time the Secretary shall provide to

18 the applicant all information provided by the Sec19 retary to such panel regarding the review of a pre20 market application.

21 ‘‘(E) The Secretary shall meet not later than

22 10 days after the panel review to present to an ap23 plicant a description of all additional information

24 necessary to require an approval of an application

25 under paragraph (1)(A) if the Secretary has deter-
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1 mined that the application appears to be in a form

2 that would receive approval within 180 days of re3 ceipt of such application. The applicant may waive

4 such meeting and instead receive in writing from the

5 Secretary such information within 30 days of the

6 panel review.

7 ‘‘(F) The Secretary shall meet with the appli8 cant not later than 15 days after the panel review

9 if the Secretary has determined that the application

10 is not in a form that would require approval under

11 paragraph (1)(A). Prior to the meeting, the Sec12 retary shall in writing present to the applicant each

13 basis for denying approval of the application and the

14 additional information necessary to bring the appli15 cation into a form that would require an approval.

16 ‘‘(G) When the Secretary reviews an application

17 and a classification panel review and recommenda18 tion is not required under subsection (c)(2), the Sec19 retary shall meet with the applicant no later than

20 135 days after receipt of an application which has

21 been accepted for filing under subsection (c)(1) and

22 inform the applicant whether or not the application

23 is in a form that would require approval under para24 graph (1)(A). If the application is in such form, the

25 Secretary shall, at or prior to the meeting, present
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1 in writing a description of all additional information

2 necessary to require an approval of an application

3 under paragraph (1)(A). If the application is not in

4 such form, the Secretary shall, prior to the meeting,

5 present in writing to the applicant each basis for de6 nying approval of the application and the additional

7 information necessary to bring the application into

8 a form that would require approval.

9 ‘‘(H) When an application is reviewed by an ac10 credited person and a classification panel is not re11 quired under subsection (c)(2) to review a premarket

12 approval application, the accredited person shall, no

13 later than 120 days after filing, or at such other

14 designated time determined by the applicant and the

15 accredited person, provide the Secretary with a re16 port and recommendation.

17 ‘‘(I) The Secretary shall approve or deny an ap18 plication reviewed by an accredited person within

19 180 days of receipt of an application which has been

20 accepted for filing under paragraph (1) unless the

21 accredited person submits its report and rec22 ommendation to the Secretary later than 150 days

23 after such receipt. If the report and recommendation

24 of an accredited person is submitted to the Secretary

25 later than 150 days after receipt of an application
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1 which has been accepted for filing under paragraph

2 (1), the Secretary shall have 30 days from the date

3 of receipt to approve or deny the application.

4 ‘‘(3)(A) The time for the Secretary’s review of an ap5 plication under this subsection shall not be enlarged by

6 any amendment to the application and shall take no more

7 than 180 days.

8 ‘‘(B) The Secretary shall ensure that each time frame

9 under paragraph (2) is met. For each instance in which

10 a review requirement under paragraph (2) is not met, a

11 report to the Commissioner and the Secretary is required

12 no later than 10 days after the date of the scheduled event

13 set forth in paragraph (2) fully explaining the reason that

14 the scheduled time frame was not met. Within 10 days

15 after receipt of such report, the Commissioner shall pro16 vide an explanation to the applicant regarding the failure

17 to comply with paragraph (2) and set the date for satisfy18 ing the scheduled review program obligation.

19 ‘‘(C) On January 1 of each calendar year, the Sec20 retary shall submit to the committees of Congress with

21 substantive oversight responsibility for the Food and Drug

22 Administration a report summarizing each instance in the

23 previous fiscal year in which the requirements of para24 graph (2) were not met. This report shall include reasons

25 for the failures to meet the requirements of paragraph (2)
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1 and proposals to ensure that such requirements will be

2 met.’’.

3 (c) REGULATIONS.—The Secretary of Health and

4 Human Services shall revise, through notice and comment

5 procedures, the regulations appearing in part 814 of title

6 21 of the Code of Federal Regulations to conform to this

7 section’s amendment of section 515 of the Federal Food,

8 Drug, and Cosmetic Act and to eliminate premarket ap9 proval of supplements which relate to manufacturing

10 changes and other changes which do not actually affect

11 device safety or effectiveness. The Secretary shall publish

12 in the Federal Register such proposed regulation no later

13 than 6 months after the date of the enactment of this Act,

14 allowing 60 days for comment. The Secretary shall publish

15 a final regulation no later than 60 days after the last day

16 for the comment period.

17 SEC. 12. ACCREDITATION OF THIRD PARTIES.

18 (a) AMENDMENT.—Subchapter A of chapter VII is

19 amended by adding at the end the following:

20 ‘‘ACCREDITED PERSONS

21 ‘‘(a) SEC. 712. IN GENERAL.—The Secretary shall,

22 within 180 days of the date of the enactment of this sec23 tion, by regulation establish procedures for the accredita24 tion of third parties for the purposes of—

25 ‘‘(1) reviewing applications under section 515,

26 providing written reviews to the Secretary for the
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1 Secretary’s consideration, and making recommenda2 tions on whether or not such applications should be

3 approved; and

4 ‘‘(2) conducting good manufacturing practice

5 inspections to determine the conformance of a facil6 ity with regulations promulgated under section

7 520(f).

8 ‘‘(b) ACCREDITATION.—

9 ‘‘(1) PROGRAMS.—The Secretary shall provide

10 for such accreditation through programs adminis11 tered by government agencies or by other qualified

12 organizations.

13 ‘‘(2) IMPLEMENTATION.—The Secretary may

14 designate one or more qualified non-government or15 ganizations to implement such programs. Such orga16 nizations shall implement such programs from fees

17 charged to applicants for accreditation.

18 ‘‘(3) QUALIFICATIONS.—An accredited person

19 shall meet the following requirements:

20 ‘‘(A) Such person shall be an independent

21 organization which is not owned or controlled

22 by manufacturer, supplier, or vendor of devices

23 and which has no organizational, material, or

24 financial affiliation with such a manufacturer,

25 supplier, or vendor.
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1 ‘‘(B) Such person shall be a legally con2 stituted entity permitted to conduct the activi3 ties for which it seeks accreditation.

4 ‘‘(C) Such person shall not engage in the

5 design, manufacture, promotion, or sale of de6 vices.

7 ‘‘(D) Such person shall be operated in ac8 cordance with generally accepted professional

9 and ethical business practices and shall agree in

10 writing that as a minimum it will—

11 ‘‘(i) certify that reported information

12 accurately reflects data reviewed;

13 ‘‘(ii) limit work to that for which com14 petence and capacity are available;

15 ‘‘(iii) treat information received,

16 records, reports, and recommendations as

17 proprietary information; and

18 ‘‘(iv) promptly respond and attempt to

19 resolve complaints regarding its activities

20 for which it is accredited.’’.

21 (b) CONFORMING AMENDMENT.—Section 301 (21

22 U.S.C. 321) is amended by redesignating the second para23 graph (u) as paragraph (v) and by adding after that para24 graph the following:

25 ‘‘(w) in the case of a drug, device, or food—
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1 ‘‘(A) the submission of a report or rec2 ommendation by a person accredited under section

3 712 that is false or misleading in any material re4 spect;

5 ‘‘(B) the disclosure by a person accredited

6 under section 712 of confidential commercial infor7 mation or any trade secret without the express writ8 ten consent of the person who submitted such infor9 mation or secret to such person; or

10 ‘‘(C) the receipt by a person accredited under

11 section 712 of a bribe in any form or the doing of

12 any corrupt act by such person associated with a re13 sponsibility delegated to such person under this

14 Act.’’.

15 SEC. 13. RECLASSIFICATION OF PREAMENDMENT DEVICES.

16 Section 515 (21 U.S.C. 360e) is amended by adding

17 at the end the following:

18 ‘‘(j) The Secretary shall, within 18 months of the

19 date of enactment of this subsection, publish in the Fed20 eral Register a proposed regulation reclassifying all de21 vices identified in subsection (i)(2) into class II except a

22 device for which the Secretary has already published a

23 proposed regulation required under subsection (i)(2). The

24 Secretary shall provide 60 days for comment on such pro25 posed regulation required by this subsection and shall pub-
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1 lish a final regulation in the Federal Register within 60

2 days after the last day for comment reclassifying into class

3 II each such device not included in a proposed regulation

4 required under subsection (i)(2) or maintaining, where ap5 propriate, the original classification of such device.’’.

6 SEC. 14. DEVICE TRACKING.

7 Subsection (e) of section 519 (21 U.S.C. 360i) is

8 amended to read as follows:

9 ‘‘(e) DEVICE TRACKING.—The Secretary may by

10 order require a manufacturer to adopt a method of track11 ing a class II or class III device—

12 ‘‘(1) the failure of which would be life threaten13 ing or have permanently debilitating effects; and

14 ‘‘(2) which is—

15 ‘‘(A) a permanently implantable device, or

16 ‘‘(B) a life sustaining or life supporting de17 vice used outside a device user facility.’’.

18 SEC. 15. POSTMARKET SURVEILLANCE.

19 Section 522 (21 U.S.C. 360l) is amended to read as

20 follows:

21 ‘‘POSTMARKET SURVEILLANCE

22 ‘‘SEC. 522. (a) IN GENERAL.—The Secretary may by

23 order require a manufacturer to conduct postmarket sur24 veillance for any device of the manufacturer first intro25 duced or delivered for introduction into interstate com26 merce after January 1, 1991, which is a class II or class
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1 III device the failure of which would be reasonably likely

2 to have serious adverse health consequences and which

3 is—

4 ‘‘(1) a permanently implantable device, or

5 ‘‘(2) a life-sustaining or life-supporting device

6 used outside a device user facility.

7 ‘‘(b) SURVEILLANCE APPROVAL.—Each manufac8 turer required to conduct a surveillance of a device shall,

9 within 30 days of receiving notice from the Secretary that

10 the manufacturer is required under this section to conduct

11 such surveillance, submit, for the approval of the Sec12 retary, a proposal for the required surveillance. The Sec13 retary, within 60 days of the receipt of such proposal, shall

14 determine if the person designated to conduct the surveil15 lance has appropriate qualifications and experience to un16 dertake such surveillance and if such proposal will result

17 in information necessary to determine the occurrence of

18 unforeseen events. Any order requiring a prospective

19 postmarket surveillance shall not require a surveillance pe20 riod greater than 18 months.’’.

21 SEC. 16. HARMONIZATION.

22 (a) SECTION 520(f).—Section 520(f)(1)(B) (21

23 U.S.C. 360j(f)(1)(B)) is amended by striking ‘‘and’’ at the

24 end of clause (i), by striking the period at the end of
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1 clause (ii) and inserting ‘‘; and’’ and by adding after

2 clause (ii) the following:

3 ‘‘(iii) ensure that such regulation conforms, to

4 the extent practicable, with the international stand5 ards organization standards defining quality sys6 tems, or parts thereof, for medical devices.’’.

7 (b) SECTION 803.—Section 803 (21 U.S.C. 383) is

8 amended by adding at the end the following:

9 ‘‘(c)(1) The Secretary shall regularly and continu10 ously participate in meetings with other countries to dis11 cuss methods and approaches to reduce the burden of reg12 ulation, harmonize regulatory requirements, and seek ap13 propriate reciprocal arrangements. The Secretary shall,

14 within 180 days of the date of enactment of this sub15 section, make public a plan that establishes a framework

16 for achieving mutual recognition of good manufacturing

17 practices.

18 ‘‘(2) The Secretary shall report to the Committee on

19 Commerce of the House of Representatives and the Com20 mittee on Labor and Human Resources of the Senate at

21 least 60 days before executing any bilateral or multilateral

22 agreement under paragraph (1).’’.

23 SEC. 17. GOOD MANUFACTURING PRACTICE INSPECTIONS.

24 (a) Section 704 (21 U.S.C. 374) is amended—
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1 (1) in subsection (a)(1), by inserting ‘‘, or an

2 accredited person to conduct good manufacturing

3 practice inspections under section 712’’ after ‘‘Sec4 retary’’;

5 (2) in subsection (a)(3), by inserting ‘‘, or an

6 accredited organization or individual under section

7 712,’’ after ‘‘employee’’;

8 (3) in subsection (b), by inserting ‘‘, or an ac9 credited person under section 712,’’ after ‘‘em10 ployee’’;

11 (4) in subsection (b), by inserting ‘‘(1)’’ after

12 ‘‘(b)’’, by redesignating clauses (1) and (2) as

13 clauses (A) and (B), respectively, and by adding at

14 the end the following:

15 ‘‘(2) The Secretary shall provide, at least 10 days

16 from the date of presentation of the report of conditions

17 or practices identified in paragraph (1), for the person re18 ceiving such report to respond. The Secretary shall take

19 no regulatory action against a person or article identified

20 in such a report until completing a review of such response

21 which is timely submitted to the Secretary, except the Sec22 retary may take immediate action when the Secretary

23 finds that there is a reasonable probability that a device

24 intended for human use would cause serious, adverse

25 health consequences or death or that any regulated article
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1 could present an unreasonable and substantial risk of in2 jury or illness to the public health. The Secretary shall

3 provide to the regulated person, within 30 days of receiv4 ing a response to the report identified in paragraph (1),

5 a written detailed assessment of the response.

6 ‘‘(3) At the time an accredited person completes an

7 inspection under the authority of this section and section

8 712, such person shall identify in writing to the person

9 subject to the inspection each condition or practice ob10 served during such inspection which suggests a deviation

11 from requirements of this Act. However, such accredited

12 person shall immediately submit to the Secretary the find13 ings of the inspection when the device to which such find14 ings relate is intended for human use and presents a rea15 sonable probability that such device would cause serious,

16 adverse health consequences or death or that such device

17 could present an unreasonable and substantial risk of in18 jury or illness to the public unless the person subject to

19 the inspection—

20 ‘‘(A) immediately ceases distribution of the de21 vice;

22 ‘‘(B) immediately notifies health professionals

23 and device user facilities to instruct such profes24 sionals and facilities to cease use of the device; and
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1 ‘‘(C) immediately undertakes all corrections

2 identified by the accredited person.

3 When such compliance is complete, the accredited person

4 shall provide the inspected person a certification of compli5 ance which includes the dates of inspections, a statement

6 that the inspected facility is in compliance with the re7 quirements of section 520(f), the date the compliance was

8 achieved at the facility, and the signature of the accredited

9 person attesting to the finding that the inspected facility

10 is in good manufacturing practices compliance as defined

11 by such section. When an accredited person has certified

12 compliance with good manufacturing practices require13 ments and provided the Secretary with a copy of the cer14 tification within 10 days of its being made, the Secretary

15 may not perform a good manufacturing practices inspec16 tion of the person subject to an inspection for a period

17 of 2 years after the date of the certification unless justified

18 by good cause.’’; and

19 (5) in subsection (c), by striking ‘‘or employee’’

20 and inserting ‘‘, employee, or accredited person’’;

21 (6) in subsection (e), by striking ‘‘or employee’’

22 each place it occurs and inserting ‘‘, employee, or ac23 credited person’’; and

24 (7) by adding at the end the following:
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1 ‘‘(f) Persons duly designated by the Secretary to con2 duct inspections under this section shall not request any

3 information not permitted under subsections (a) and (e)

4 unless such person states with specificity and in writing

5 the identification of the information subject to the request,

6 the reason for the request, and that the written request

7 seeks to obtain information not required to be produced

8 under this section. Such request shall not include informa9 tion related to sales (other than distribution), personnel,

10 or pricing data.’’.

11 SEC. 18. USE OF SCIENTIFIC AND MEDICAL INFORMATION.

12 Section 502(f) (21 U.S.C. 352(f)) is amended by add13 ing at the end the following: ‘‘The dissemination of medi14 cal texts, articles from peer-reviewed scientific publica15 tions, information from Federal Government agencies, and

16 presentations at medical and scientific meetings shall not

17 form a basis to require adequate directions for use under

18 clause (1) or information for use (or the equivalent there19 of) under any exemption to clause (1) and shall not form

20 a basis to require the filing of a report required under

21 section 510(k) or the filing of an application under section

22 505 or 515 unless such person, in addition to disseminat23 ing the above-referenced information, encourages the un24 approved use of a legally marketed device through label25 ing, advertising, or other means of promotion. Mere
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1 knowledge that a legally available device is used by li2 censed practitioners for the treatment or diagnosis of dis3 eases or conditions in individual patients shall not form

4 a basis to require adequate directions for use under clause

5 (1), or information for use (or the equivalent thereof)

6 under any exemption to clause (1), and shall not form a

7 basis to require either the filing of a notification required

8 under section 510(k) or an application under section 515.

9 The Secretary shall not consider the dissemination of med10 ical texts, articles from peer review scientific publications,

11 information from Federal Government agencies, presen12 tations at medical and scientific meetings, and displays at

13 trade shows relating to a device which is investigational

14 within the meaning of section 520(g) to be activities pro15 hibited under published regulations of the Secretary unless

16 the sponsor of an investigation for the device, or an agent

17 of such sponsor, in addition to the aforementioned activi18 ties encourages the use of a device.’’.

19 SEC. 19. REPORTS.

20 (a) EXCLUSION OF REPORTS BY DISTRIBUTORS.—

21 Section 519 (21 U.S.C. 360i) is amended—

22 (1) in subsection (a), by striking ‘‘manufac23 turer, importer, or distributor’’ and inserting ‘‘man24 ufacturer or importer’’;
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1 (2) in paragraph (4) of subsection (a), by strik2 ing ‘‘manufacturer, importer, or distributor’’ and in3 serting ‘‘manufacturer or importer’’;

4 (3) in paragraph (8) of subsection (a), by strik5 ing ‘‘manufacturer, importer, or distributor’’ each

6 place it occurs and inserting ‘‘manufacturer or im7 porter’’;

8 (4) in paragraph (8)(B)(i) of subsection (a), by

9 striking ‘‘manufacturer, importer, or distributor’’

10 and inserting ‘‘manufacturer or importer’’; and

11 (5) in subsection (a), by inserting ‘‘and’’ at the

12 end of paragraph (7), by striking ‘‘; and’’ at the end

13 of paragraph (8) and inserting a period, by striking

14 paragraph (9).

15 (b) LIMITATION ON MALFUNCTION REPORTING.—

16 Section 519(a)(1)(B) (21 U.S.C. 360i(a)(1)(B)) is amend17 ed by inserting before the semicolon the following: ‘‘, ex18 cept that information that a device failed to perform as

19 labeled or in an acceptable manner shall not constitute a

20 malfunction within the meaning of this subparagraph

21 when the available information clearly shows that the de22 vice failure was caused by improper servicing or mainte23 nance to the device as determined exclusively by the device

24 labeling which was provided to the user’’.
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1 (c) REGULATIONS.—Within 120 days after the date

2 of enactment of this section, the Secretary of Health and

3 Human Services shall delete the regulations of the Sec4 retary appearing in part 800 of title 21 of the Code of

5 Federal Regulations, requiring distributors, other than

6 importers, to make reports of deaths, serious injuries or

7 illness, and malfunctions related to devices and shall

8 amend the regulations of the Secretary to conform to the

9 change in malfunction reporting in section 519(a)(1)(B)

10 of the Federal Food, Drug, and Cosmetic Act.

11 (d) USER REPORTS, CERTIFICATIONS, AND REPORTS

12 OF REMOVALS AND CORRECTIONS.—Section 519 (21

13 U.S.C. 360i) is amended by repealing subsections (b), (d),

14 and (f).

15 SEC. 20. G.M.P. AND DEVICE REPORTS.

16 Section 303(c) is amended by inserting before the pe17 riod at the end the following: ‘‘; or (6) for having violated

18 subsection (a), (b), (c), or (k) of section 301 by failure

19 to comply with either section 502(t)(2) or 501(h), or for

20 having violated section 301(g)(1)(B) by failing to furnish

21 material or information required under section 519(a), if

22 such person acted in good faith, had no reason to believe

23 that the person’s acts violated the law, and had no prior

24 notice from the Secretary that the acts constituted viola25 tions of the Act’’.
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1 SEC. 21. CIVIL PENALTIES.

2 Section 303 (21 U.S.C. 333) is amended—

3 (1) in subsection (g)(2)(C), by adding at the

4 end the following: ‘‘Additionally, the Secretary may

5 direct a person subject to a civil penalty under para6 graph (1) to apply the monetary amount of the pen7 alty to the correction of the violation that resulted

8 in the penalty assessment in lieu of paying such

9 moneys into the United States Treasury. Any person

10 who undertakes correction of violations under this

11 subparagraph must submit an independent audit of

12 the corrections to the Secretary within a time speci13 fied in the civil penalty order. A failure to submit

14 such independent audit in a timely manner shall be

15 deemed to be a violation of this Act.’’; and

16 (2) in subsection (f)(2), by adding at the end

17 ‘‘The person accused of a violation under this sub18 section shall be entitled to reasonable discovery in

19 accordance with the Federal Rules of Civil Proce20 dure.’’.

21 SEC. 22. INFORMATION SYSTEM.

22 Chapter IX, as amended by section 9, is amended by

23 adding at the end the following:

24 ‘‘SEC. 907. INFORMATION SYSTEM.

25 ‘‘The Secretary shall establish and maintain an infor26 mation system to track the status and progress of each
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1 application or submission (including a petition, notifica2 tion, or other similar form of request) submitted to the

3 Food and Drug Administration requesting agency action.

4 The system shall permit access by the applicant.’’.

5 SEC. 23. ENVIRONMENTAL IMPACT REVIEW.

6 Chapter VII, as amended by section 13, is amended

7 by adding at the end the following:

8 ‘‘SUBCHAPTER E—ENVIRONMENTAL IMPACT REVIEW

9 ‘‘SEC. 745. ENVIRONMENTAL IMPACT REVIEW.

10 ‘‘No action by the Secretary pursuant to this Act

11 shall require, with respect to an action to be taken by the

12 Secretary, the preparation of an environmental impact

13 statement under the National Environmental Policy Act

14 of 1969 or an environmental assessment unless the Sec15 retary demonstrates that—

16 ‘‘(1) because of extraordinary circumstances the

17 action will have a significant effect on the human

18 environment; and

19 ‘‘(2) the consideration of such significant effect

20 on the human environment will directly affect the

21 Secretary’s decision on the action.’’

22 SEC. 24. INFORMAL AGENCY STATEMENTS.

23 Section 701 (21 U.S.C. 371) is amended by adding

24 at the end the following:
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1 ‘‘(h)(1) The Secretary shall not rely upon informal

2 agency statements, including guidance documents, policy

3 statements, points to consider documents, or any other

4 statements that have not been promulgated in accordance

5 with the rulemaking requirements of chapter V of title 5,

6 United States Code, to require any action be taken to sat7 isfy a requirement of this Act.

8 ‘‘(2) The Secretary shall publish notice in the Federal

9 Register of the availability to the public of each type of

10 statement identified in paragraph (1). Additionally, the

11 Secretary shall undertake to make available all such state12 ments by electronic or other similar means.

13 SEC. 25. EDUCATION AND RESEARCH; PRACTICE OF MEDI14 CINE.

15 Chapter IX, as amended by section 23, is amended

16 by adding at the end the following:

17 ‘‘SEC. 908. EDUCATION AND RESEARCH.

18 ‘‘(a) EDUCATION.—The Secretary shall conduct

19 training and education programs for the employees of the

20 Food and Drug Administration relating to the regulatory

21 responsibilities and policies established by this Act, includ22 ing programs for scientific training, administrative process

23 and procedure, and integrity issues.

24 ‘‘(b) RESEARCH.—The Secretary, acting through the

25 Food and Drug Administration, may conduct or contract
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1 for scientific research only if it is directly related to the

2 implementation of this Act.

3 ‘‘SEC. 909. PRACTICE OF MEDICINE.

4 ‘‘Nothing in this Act shall be construed to limit or

5 interfere with the authority of a health care practitioner,

6 licensed by law to administer drugs and devices, to pre7 scribe or administer any legally marketed drug or device

8 to a patient for any condition or disease within a legiti9 mate health care practitioner-patient relationship.’’.

10 SEC. 26. PUBLICATION OF NOTICE OF DEVIATION.

11 Section 705 (21 U.S.C 375) is amended by adding

12 at the end the following:

13 ‘‘(c) The Secretary may make public or communicate

14 to any person outside the Food and Drug Administration

15 any information regarding a notice which informs a regu16 lated person of a purported deviation from a requirement

17 of this Act only after the Secretary has completed the in18 vestigation of such deviation.’’.

Æ