I

104TH CONGRESS

1ST SESSION H. R. 2290

To amend the medical device provisions of the Federal Food, Drug, and

Cosmetic Act.

IN THE HOUSE OF REPRESENTATIVES

SEPTEMBER 8, 1995

Mr. FOX of Pennsylvania introduced the following bill; which was referred to

the Committee on Commerce

A BILL

To amend the medical device provisions of the Federal Food,

Drug, and Cosmetic Act.

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled,

3 SECTION 1. SHORT TITLE AND REFERENCE.

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

5 ‘‘Life Extending and Life Saving Device Act of 1995’’.

6 (b) REFERENCE.—Whenever in this Act an amend7 ment or repeal is expressed in terms of an amendment

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

9 shall be considered to be made to a section or other provi-
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1 sion of the Federal Food, Drug, and Cosmetic Act (21

2 U.S.C. 201 et seq.).

3 SEC. 2. DEFINITIONS.

4 Section 201 (21 U.S.C. 321) is amended—

5 (1) in paragraph (h), by striking ‘‘reagent’’ and

6 inserting ‘‘in vitro diagnostic test system, special

7 purpose reagent,’’, and

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

9 ‘‘(gg) The term ‘special purpose reagent’ means any

10 monoclonal or polyclonal antibody, antigen, genetic probe,

11 or other similar or related article that is a component of

12 an in vitro diagnostic test system.

13 ‘‘(hh) The term ‘in vitro diagnostic test system’

14 means a system intended for use in the diagnosis of dis15 ease or other conditions, including a determination of the

16 state of health, in order to cure, mitigate, treat, or prevent

17 disease or its sequelae.’’.

18 SEC. 3. MISSION OF THE FOOD AND DRUG ADMINISTRA19 TION.

20 Section 903 (21 U.S.C. 393) is amended by adding

21 at the end the following:

22 ‘‘(d) The mission of the Food and Drug Administra23 tion (with respect to drugs, biological products, and de24 vices) is to promote and protect the health of the American

25 people. This mission should be achieved by—
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1 ‘‘(1) facilitating the timely availability of safe

2 and effective products that benefit the American

3 public,

4 ‘‘(2) encouraging the efficient development of

5 new products in the United States,

6 ‘‘(3) taking prompt and appropriate action

7 where postmarketing surveillance demonstrated that

8 products present a health risk to the American pub9 lic,

10 ‘‘(4) ensuring that human drugs, biological

11 products, and devices are tested and manufactured

12 consistent with the goal of harmonization of inter13 national standards,

14 ‘‘(5) facilitating the flow of information to edu15 cate health professionals and the American public,

16 and

17 ‘‘(6) enforcing the applicable statutes and regu18 lations in a timely, fair, and decisive manner.’’.

19 SEC. 4. HARMONIZATION.

20 Section 803 (21 U.S.C. 383) is amended by adding

21 at the end the following:

22 ‘‘(c)(1) The Secretary shall take such action as may

23 be appropriate to harmonize the requirements of this Act

24 for good manufacturing practice regulations with require25 ments of similar laws in foreign countries through the
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1 International Conference on Harmonization by December

2 1996.

3 ‘‘(2) The Secretary shall regularly participate in

4 meetings with other foreign governments to discuss meth5 ods and approaches to harmonize international regulatory

6 requirements. The office shall forward any proposed

7 agreements resulting from such meetings to the appro8 priate officials in each participating country for consider9 ation in the formulation of agreements to harmonize inter10 national regulatory requirements. The office shall have the

11 responsibility of ensuring that the process of harmonizing

12 international regulatory requirements for devices and

13 drugs is continuous.

14 ‘‘(3) The Commissioner shall initially report to com15 mittees of the United States Congress with oversight re16 sponsibilities for the United States Food and Drug Ad17 ministration regarding the efforts and accomplishments of

18 the office no later than 18 months after the date of enact19 ment of this paragraph. Thereafter, the Commissioner

20 shall report to such committees biennially.’’.

21 SEC. 5. PREMARKET NOTIFICATION.

22 (a) Section 510 (21 U.S.C. 360) is amended—

23 (1) in subsection (k), by inserting ‘‘excluding

24 any device classified into class I under section 513

25 or 520, or any device classified into class II under
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1 section 513 or 520, if such class II device has been

2 exempted from the requirements of this subsection

3 under paragraph (1),’’ after ‘‘a device intended for

4 human use’’,

5 (2) in subsection (k), by striking ‘‘report’’ and

6 inserting ‘‘have the option of reporting’’,

7 (3) in subsection (k), by striking ‘‘or any per8 son who is not an employee of the United States,

9 and who is accredited by the Secretary or the Sec10 retary’s designee to receive and review notifications

11 required under this subsection and to make rec12 ommendations under subsection 513(f)(1) about

13 such notifications’’ after ‘‘report to the Secretary’’,

14 and

15 (4) by inserting after subsection (k) the follow16 ing:

17 ‘‘(l) Within 3 months after the date of the enactment

18 of this subsection, the Secretary shall publish a notice in

19 the Federal Register soliciting from the public the identi20 fication of class II devices that should not be subject to

21 the notification requirements of subsection (k) because

22 such notification is unnecessary to ensure public health.

23 The notice shall provide no more than 30 days for submis24 sion of information to the Secretary, and the Secretary

25 shall by regulation exempt specified class II devices from
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1 notification under subsection (k). The proposal for such

2 a regulation shall permit 30 days for comment. The Sec3 retary shall publish a final regulation in the Federal Reg4 ister no later than 45 days after the end of the comment

5 period. If the Secretary fails to promulgate a final regula6 tion 45 days after the end of the comment period, each

7 class II device proposed for exemption from subsection (k)

8 shall be deemed to be exempt from that subsection.

9 ‘‘(m) The Secretary may not withhold a determina10 tion of the initial classification of a device under section

11 513(f)(1) for any reason, including that the facility in

12 which a device may be manufactured is not in compliance

13 with good manufacturing practice requirements set forth

14 in regulations promulgated under the authority of section

15 520(f).’’.

16 (b) NOTICE.—Section 513(f) (21 U.S.C. 360c(f)) is

17 amended by redesignating paragraphs (2) and (3) as para18 graphs (3) and (4), respectively, and by inserting after

19 paragraph (1) the following:

20 ‘‘(2)(A) If the Secretary fails to make a determina21 tion under paragraph (1)(A) within 90 days of receipt of

22 a notification required by subsection (k), the Secretary

23 shall send a letter by registered mail to the submitter of

24 such notification stating that additional time is necessary

25 to determine the initial classification of the device. Addi-
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1 tionally, such letter shall state each reason necessitating

2 the need for additional time and provide the submitter a

3 date for completion.

4 ‘‘(B) Within 90 days of receiving a notification re5 quired under subsection (k) for devices identified as being

6 substantially equivalent to a class II device, a person ac7 credited to conduct reviews of such notifications shall

8 make a determination of initial classification under para9 graph (1)(A) of any such device which was not introduced

10 or delivered for introduction into interstate commerce for

11 commercial distribution before the date of enactment of

12 this section. Such determination of initial classification

13 shall be final. The accredited person shall immediately, by

14 registered mail, provide to the submitter of such notifica15 tion an order classifying the device. If the accredited per16 son determines that the device should be classified into

17 class III, such person shall refer the premarket notifica18 tion submission to the Secretary. The Secretary shall have

19 30 days to review the submission and issue an order ini20 tially classifying the device. If the Secretary fails to make

21 a classification decision within 30 days, the Secretary shall

22 send a letter to the submitter of the notification which

23 conforms to the requirements of subparagraph (A).

24 ‘‘(C) Within 60 days of receiving a notification re25 quired under subsection (k) for a device identified as being
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1 substantially equivalent to a class III device, a person ac2 credited to conduct reviews of such notification shall make

3 a determination of the initial classification under para4 graph (1)(A) of any such device which was not introduced

5 or delivered for introduction into interstate commerce for

6 commercial distribution before the date of enactment of

7 this section, and within such time period submit a rec8 ommendation to the Secretary and to the submitter of the

9 premarket notification which contains such determination.

10 The recommendation by such person of initial classifica11 tion of a device shall be binding upon the Secretary, unless

12 the Secretary within 30 calendar days of receipt of the

13 recommendation finds that the recommendation is clearly

14 erroneous, issues an order under this subsection initially

15 classifying the device and provides, as part of the order,

16 a detailed explanation of the basis for the finding that the

17 classification recommendation of the accredited person is

18 clearly erroneous. If within 90 days from the date of re19 ceipt of the notification the Secretary does not issue an

20 order that differs from the recommendation of the accred21 ited person, the Secretary shall promptly send by reg22 istered mail to the submitter of the notification such rec23 ommendation as the Secretary’s order of initial classifica24 tion. If the Secretary does not provide the submitter such

25 notification by registered mail as specified herein, the rec-
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1 ommendation of classification provided to the submitter

2 of the premarket notification shall become the Secretary’s

3 order of initial classification of the device. Such classifica4 tion may only be charged pursuant to the procedures spec5 ified in paragraph (3) of this subsection.

6 ‘‘(D) Any change or modification to a device initially

7 classified under this subsection, other than a major change

8 (including any major modification) in the intended use,

9 shall not require an additional submission under sub10 section (k) if such change or modification is supported by

11 appropriate data or information, and the change or modi12 fication can be shown to not adversely affect the safety

13 or effectiveness of the device which was initially classified

14 under this subsection. All data or information relied upon

15 to document that a change to (including any modification

16 of) such device does not require an additional notification

17 under subsection (k) shall be made a part of the good

18 manufacturing practice document file required by regula19 tions promulgated under section 520(f) and shall be main20 tained for a period of time equal to the commercial life

21 of the device, at a minimum.’’.

22 (c) Section 513(i)(1) (21 U.S.C. 360c(i)(1)) is

23 amended by adding after subparagraph (B) the following:

24 ‘‘(C) For the purpose of determining the intended use

25 of a predicate device under subparagraph (A), each use
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1 reasonably included within a general use for the predicate

2 device shall be deemed a legally marketed use of the predi3 cate device and shall be available in premarket notifica4 tions required under subsection (k).

5 ‘‘(D) For the purpose of determining substantial

6 equivalence, the Secretary shall not consider any uses or

7 indications of a device that are not specifically identified

8 in a premarket market notification submission under sub9 section (k).’’.

10 SEC. 6. THE RISK/BENEFIT DETERMINATION.

11 Section 513(a)(2)(A) is amended by striking the

12 comma following the word ‘‘intended’’ and adding to the

13 end of the paragraph the following: ‘‘by the person legally

14 responsible for labeling the device,’’.

15 SEC. 7. EFFECTIVENESS DETERMINATION.

16 (a) Section 513(a)(3)(A) (21 U.S.C. 360c(a)(3)(A))

17 is amended by adding at the end the following: ‘‘Well-con18 trolled clinical investigations shall not be appropriate, un19 less the Secretary determines, after consultation with an

20 advisory committee constituted under subsection (b) that

21 such investigations are necessary to demonstrate that the

22 device will have the effect it purports or is represented

23 to have under the conditions of use prescribed, rec24 ommended, or suggested in the labeling of the device. Any

25 person may submit well-controlled clinical investigations
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1 to the Secretary to demonstrate that a device will have

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

3 conditions of use prescribed, recommended as suggested

4 in the labeling of the device, and, without reliance on an

5 advisory committee, the Secretary may determine that

6 such studies are appropriate for such purpose.’’.

7 (b) Section 513(a)(3) (21 U.S.C. 360c(a)(3)) is

8 amended by adding at the end the following:

9 ‘‘(C) The determination of effectiveness shall not in10 clude any of the following:

11 ‘‘(i) The evaluation of clinical outcomes, if the

12 use of a device provides a medical contribution to

13 the diagnosis or treatment of the persons for whom

14 the device is intended, unless the device is rep15 resented in the labeling of the device to provide a

16 therapeutic effect to the persons for whom the device

17 is intended.

18 ‘‘(ii) The evaluation of relative effectiveness,

19 unless the performance of a device is compared to

20 that of another device through labeling or other rep21 resentations by the person legally responsible for the

22 labeling of the device.

23 ‘‘(iii) The evaluation of cost effectiveness rep24 resentations.
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1 ‘‘(iv) The evaluation of any indication for use

2 not included in the labeling of a device, unless the

3 person legally responsible for the labeling of the de4 vice promotes such indications for use.’’.

5 SEC. 8. PREMARKET APPROVAL.

6 (a) Section 515(c)(1) (21 U.S.C. 360e(c)(1)) is

7 amended by inserting ‘‘, or may file such application with

8 a person or organization authorized to review applications

9 for premarket approval’’ after ‘‘class III device’’ and by

10 redesignating paragraph (2) as paragraph (4) and by add11 ing after paragraph (1) the following:

12 ‘‘(2)(A) Persons or organizations authorized to re13 ceive and review applications for approval of class III de14 vices shall review such applications in accordance with the

15 schedule of events identified in subsection (d)(2), unless

16 such organization or person by contract with an applicant

17 alters the schedule of events or eliminates any such event

18 other than the requirements to file an application before

19 undertaking a substantive review, refer an application

20 under subparagraph (C) to an advisory committee con21 stituted under the authority of section 513(b), and com22 plete the review of an application in a timely manner.

23 ‘‘(B) The review standard for a premarket approval

24 application applicable to such persons or organizations
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1 shall be identical in all respects to the standard of review

2 the Secretary is required to follow under this section.

3 ‘‘(C) The scope of review responsibility of such per4 sons or organizations authorized to conduct reviews of pre5 market approval applications shall include—

6 ‘‘(i) the filing of applications for substantive re7 view,

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

9 whether there is a reasonable assurance that a de10 vice is safe and effective for its labeled uses,

11 ‘‘(iii) the presentation, when appropriate, of

12 such applications to an advisory committee con13 stituted under section 513(b), and

14 ‘‘(iv) the evaluation of advisory committee rec15 ommendations and premarket approval applications

16 and the formulation of reports and recommendations

17 to be submitted to the Secretary no later than 30

18 days after receipt of an advisory committee’s rec19 ommendation.

20 Recommendations to the Secretary shall specify whether

21 an application should be approved or denied and shall

22 state the basis for the recommendation.

23 ‘‘(D) If an advisory committee is not required to re24 view a premarket approval application, such person or or25 ganization shall no later than 120 days after filing, or at
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1 such other designated time determined by the applicant

2 and the accredited person, provide the Secretary with a

3 report and recommendation in accordance with the re4 quirements of subparagraph (C).

5 ‘‘(E) The Secretary shall approve or deny an applica6 tion reviewed by an accredited person within 180 days of

7 receipt of an application which has been accepted for filing

8 under subsection (c), unless the accredited person submits

9 its report and recommendation to the Secretary later than

10 150 days after such receipt. If the report and rec11 ommendation of an accredited person is submitted to the

12 Secretary later than 150 days after receipt of an applica13 tion which has been accepted for filing under subsection

14 (c), the Secretary shall have 30 days from the date of re15 ceipt to approve or deny the application.

16 ‘‘(F) The recommendation of an accredited person to

17 approve or deny an application shall be binding upon the

18 Secretary, unless the Secretary finds that such rec19 ommendation is clearly erroneous. In the event that the

20 Secretary makes such a finding, the Secretary shall pro21 vide a detailed explanation of the basis therefor.

22 ‘‘(G) The Secretary shall approve or deny applica23 tions for premarket approval of class III devices pursuant

24 to the requirements of subsection (d).
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1 ‘‘(3) The Secretary may use experts qualified by

2 training and experience in addition to employees of the

3 United States Government to review applications. Reviews

4 by such experts may relate to portions of an application

5 or entire applications. Each such review shall be in writing

6 and submitted to the Secretary for consideration of wheth7 er to approve a device for commercial distribution.’’.

8 (b) Section 515(c) (21 U.S.C. 360e(c)), as amended

9 by subsection (a), is amended by adding the following at

10 the end of paragraph (4): ‘‘Such panel shall be scheduled

11 to meet at least 4 times each calendar year to consider

12 among other things the approval of applications submitted

13 to the Secretary under this subsection. Such meetings

14 shall, to the extent possible, be scheduled at equal inter15 vals throughout the year.’’.

16 (c) Section 515(d) (21 U.S.C. 360e(d)) is amended

17 by redesignating paragraphs (2) and (3) as paragraphs

18 (5) and (6), respectively, and by inserting after paragraph

19 (1) the following:

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

21 shall be reviewed in the following manner to achieve final

22 action on such applications within 180 days of their re23 ceipt:

24 ‘‘(A) The Secretary shall make a determination

25 within 30 days of receipt of an application submitted
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1 under subsection (c) of whether the application sat2 isfies the content requirements of subsection (c)(1)

3 and applicable regulations.

4 ‘‘(B) The Secretary shall meet with an appli5 cant within 90 days of receipt of an application that

6 has been accepted for filing to discuss the review

7 status of the application. If the application does not

8 appear in a form that would necessitate an approval

9 under this subsection, the Secretary shall, in writing

10 and prior to the meeting, present to the applicant a

11 description of any deficiencies with the application

12 and what information would be necessary to bring

13 the application into a form that would require an

14 approval.

15 ‘‘(C) The Secretary shall provide an applicant

16 the opportunity for a meeting 115 days after receipt

17 of an application which has been accepted for filing

18 under subsection (c) to inform the applicant of the

19 status of the application, advise the applicant of any

20 deficiencies in the application not previously commu21 nicated to the applicant, review proposed labeling for

22 the device, and review the actions taken to correct

23 deficiencies identified at the meeting held on the

24 90th day after receipt of the filed application.
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1 ‘‘(D) The Secretary shall refer an application to

2 a panel established under section 513 for review and

3 for an approval recommendation, unless a panel is

4 not required under subsection (c)(2), within 30 days

5 of the meeting referenced in subparagraph (B) or at

6 the next scheduled panel meeting following such

7 meeting, whichever is later.

8 ‘‘(E) The Secretary shall meet with the appli9 cant within 30 days of the panel review if the Sec10 retary has determined that the application is not in

11 a form that would require approval under this sub12 section. Prior to the meeting, the Secretary shall, in

13 writing, present to the applicant each basis for deny14 ing approval of the application and the additional in15 formation necessary to bring the application into a

16 form that could be approved.

17 ‘‘(F) The Secretary shall meet within 10 days

18 of the panel review to present to an applicant a de19 scription of all additional information necessary to

20 require an approval of an application under this sub21 section if the Secretary has determined that the ap22 plication appears to be in a form that would receive

23 approval within 180 days of receipt of such applica24 tion. The applicant may waive such meeting and in-
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1 stead receive in writing from the Secretary, within

2 30 days of the panel review, such information.

3 ‘‘(G) The Secretary shall meet with the appli4 cant no later than 150 days after receipt of an ap5 plication which has been accepted for filing under

6 subsection (c), if an advisory panel is not required

7 under subsection (c)(2), and inform the applicant

8 whether or not the application is in a form that

9 could be approved under this subsection. If the ap10 plication is in such form, the Secretary shall, at or

11 prior to the meeting, present in writing a description

12 of all additional information necessary to require an

13 approval of an application under this subsection. If

14 the application is not in such form, the Secretary

15 shall, prior to the meeting, present in writing to the

16 applicant each basis for denying the approval of the

17 application and the additional information necessary

18 to bring the application into a form that could be

19 approved.

20 ‘‘(H) The Secretary shall issue an order either

21 approving or denying an application within 180 days

22 of receipt of an application that has been accepted

23 for filing.

24 ‘‘(3)(A) The time for the Secretary’s review of an ap25 plication under this subsection shall not be enlarged by
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1 any amendment to the application and shall take no more

2 than 180 days.

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

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

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

6 report to the Secretary is required no later than 10 days

7 after the date of the scheduled event set forth in para8 graph (2) fully explaining the reason that the scheduled

9 time frame was not met. Within 10 days after receipt of

10 such report, the Secretary shall provide an explanation to

11 the applicant regarding the failure to comply with para12 graph (2) and set the date for satisfying the scheduled

13 review program obligation.

14 ‘‘(C) On January 1 of each calendar year, the Sec15 retary shall submit to the committees of Congress with

16 substantive oversight responsibility for the Food and Drug

17 Administration a report summarizing each instance in the

18 previous fiscal year in which the requirements of para19 graph (2) were not met. This report shall include reasons

20 for the failures to meet the requirements of paragraph (2)

21 and proposals to ensure that such requirements will be

22 met.

23 ‘‘(4) In order to better treat or diagnose life-threaten24 ing or irreversibly debilitating diseases or conditions of
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1 man, the Secretary shall promulgate regulations to create

2 review priority for devices—

3 ‘‘(A) representing breakthrough technologies;

4 ‘‘(B) for which no approved alternatives exist;

5 ‘‘(C) which offer significant advantages over ex6 isting approved alternatives; or

7 ‘‘(D) the availability of which is in the best in8 terest of the public health.

9 Such regulations shall include criteria for identifying de10 vices which merit preferential review and shall specify pro11 cedures for implementing such reviews. The Secretary

12 shall publish in the Federal Register a proposed regulation

13 no later than 6 months after the date of enactment of the

14 paragraph, allowing 60 days for comment. The Secretary

15 shall publish a final regulation no later than 60 days after

16 the last day of the comment period.’’.

17 (d) Section 515(d) (21 U.S.C. 360e(d)) is amended

18 by adding before the semicolon at the end of paragraph

19 (5)(B) the following: ‘‘(the determination of a reasonable

20 assurance that a device is effective under the conditions

21 of use prescribed, recommended, or suggested in proposed

22 labeling shall not include uses or indications for use not

23 identified in the application)’’.

24 (e) The Secretary of Health and Human Services

25 shall revise, through notice and comment procedures, the
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1 regulations appearing in title 21 of the Code of Federal

2 Regulations, part 814, to conform the regulations to the

3 amendments of section 515 of the Federal Food, Drug,

4 and Cosmetic Act made by this section and to eliminate

5 premarket approval of supplements which relate to manu6 facturing changes and other changes which do not actually

7 affect device safety or effectiveness.

8 SEC. 9. INVESTIGATIONAL DEVICE EXEMPTIONS.

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

10 adding at the end the following:

11 ‘‘(6) The Secretary of Health and Human Services

12 shall, within 120 days of the date of enactment of this

13 paragraph, by regulation amending the content of parts

14 812 and 813 of title 21 of the Code of Federal Regula15 tions, update the procedures and conditions under which

16 devices intended for human use may upon application be

17 granted an exemption from certain requirements under

18 the Act. Such regulation shall—

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

20 outside of the investigational protocol, in the diag21 nosis or treatment of diseases or conditions that are

22 life threatening or could be irreversibly debilitating,

23 when the risk of not using the investigational device

24 exceeds the probable risk of using such device as de25 termined by the local institutional review board;
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1 ‘‘(B) require that prior to submitting an appli2 cation to the Secretary, any person intending to in3 vestigate the safety or effectiveness of a class III de4 vice or an implant may submit an investigational

5 plan, including clinical protocol, to the Secretary for

6 review; and

7 ‘‘(C) provide a submitter who disputes the Sec8 retary’s response under subparagraph (B) a right to

9 appear before an advisory committee of the inves10 tigational plan and the Secretary’s evaluation of

11 such plan.

12 Within 30 days of receipt of an investigational plan under

13 subparagraph (B), the Secretary shall respond in writing

14 to the submitter identifying each deficiency with the plan

15 and such other information that will facilitate the review

16 and approval of an application.’’.

17 SEC. 10. CLASSIFICATION AND RECLASSIFICATION OF IN

18 VITRO DIAGNOSTIC TEST SYSTEMS.

19 (a) Section 513 (21 U.S.C. 360c) is amended by add20 ing at the end the following:

21 ‘‘INITIAL CLASSIFICATION AND RECLASSIFICATION OF IN

22 VITRO DIAGNOSTIC TEST SYSTEMS

23 ‘‘(j) Any class III in vitro diagnostic test system in24 tended for human use which was introduced or delivered

25 for introduction into interstate commerce for commercial

26 distribution before the date of enactment of this para-
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1 graph is deemed to be automatically reclassified by the

2 Secretary in class II on the date 1 year after the date

3 of enactment of this subsection unless the Secretary, by

4 regulation, finds that classification of the device in class

5 III is necessary to provide reasonable assurance of its

6 safety and effectiveness. Any such device that the Sec7 retary classifies in class III shall remain in class III for

8 3 years after the effective date of the regulation classifying

9 the device in class III. At the end of the 3-year period,

10 the device is deemed to be automatically reclassified by

11 the Secretary in class II unless the Secretary, by notice

12 and comment rulemaking, extends the class III designa13 tion for an additional period of time. Any proposed regula14 tion issued under this subsection finding that a device

15 shall be classified in class III shall be accompanied by a

16 full statement of the reasons (and supporting documenta17 tion and data) of the Secretary for finding that classifica18 tion of the device in class III is necessary to provide rea19 sonable assurance of its safety and effectiveness and that

20 reclassification in class II will not provide such assurance.

21 ‘‘CLASSIFICATION

22 ‘‘(k) Any in vitro diagnostic test system intended for

23 human use which is intended to be introduced or delivered

24 for introduction into interstate commerce for commercial

25 distribution on or after the date of enactment of this sub26 section is deemed to be classified by the Secretary in class
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1 II unless the Secretary, by regulation, finds that classifica2 tion of the device in class III is necessary to provide rea3 sonable assurance of its safety and effectiveness. Any such

4 device that the Secretary classifies in class III shall re5 main in class III for 3 years after the effective date of

6 the regulation classifying the device in class III. At the

7 end of that 3-year period, the device is deemed to be auto8 matically reclassified by the Secretary in class II unless

9 the Secretary, by notice and comment rulemaking, extends

10 the class III designation for an additional period of time.

11 Any proposed regulation issued under this subsection find12 ing that a device shall be classified in class III shall be

13 accompanied by a full statement of the reasons (and sup14 porting documentation and data) of the Secretary for find15 ing that classification in class II will not provide such as16 surance.’’.

17 (b) Section 520(l)(1) (21 U.S.C. 360j(l)(1)) is

18 amended by adding after ‘‘has classified such device in

19 class I or II’’ the following: ‘‘, except that any device in20 tended for human use described in subparagraphs (A)

21 through (F) which is an in vitro diagnostic test system

22 is deemed to be classified by the Secretary in class II on

23 the date 1 year after the date of enactment of this para24 graph unless the Secretary in response to a petition sub25 mitted under paragraph (2) has classified such device in
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1 class I, or the Secretary, by regulation, finds that classi2 fication of the device in class III is necessary to provide

3 reasonable assurance of its safety and effectiveness. Any

4 such device that the Secretary classifies in class III shall

5 remain in class III for 3 years after the effective date of

6 the regulation classifying the device in class III. Any such

7 device that the Secretary classifies in class III shall re8 main in class III for 3 years after the effective date of

9 the regulation classifying the device in class III unless the

10 Secretary, by notice and comment rulemaking, extends the

11 class III designation for an additional period of time. At

12 the end of that 3-year period, the device is deemed to be

13 automatically reclassified by the Secretary in class II. Any

14 proposed regulation issued under this paragraph finding

15 that a device shall be classified in class III shall be accom16 panied by a full statement of the reasons (and supporting

17 documentation and data) of the Secretary for finding that

18 classification of the device in class III is necessary to pro19 vide reasonable assurance of its safety and effectiveness

20 and that reclassification in class II will not provide such

21 assurance’’.

22 SEC. 11. REGULATION OF SPECIAL PURPOSE REAGENTS.

23 Section 513 (21 U.S.C. 360c), as amended by section

24 8, is amended by adding at the end the following:
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1 ‘‘SPECIAL PURPOSE REAGENTS

2 ‘‘(l) Any special purpose reagent is deemed to be clas3 sified by the Secretary in class I, subject to the ‘general

4 controls’ defined in subsection (h), except the premarket

5 notification requirement of section 510(k), if—

6 ‘‘(1) the labeling complies with all requirements

7 that the Secretary, by regulation, establishes for in

8 vitro diagnostic test systems, including a require9 ment that a certificate of analysis provided by the

10 manufacturer of the special purpose reagent shall be

11 limited to a description of the physical and chemical

12 properties of the device, the quantity provided, ap13 propriate storage instruction, expiration date, and

14 the results of any quality or purity testing conducted

15 by the manufacturer;

16 ‘‘(2) the label for the device bears the statement

17 ‘For manufacturing or laboratory use only,’; and

18 ‘‘(3) distribution of the device is restricted to

19 laboratories licensed by the Secretary under section

20 353 of the Public Health Service Act to perform

21 ‘high complexity’ testing as the Secretary, by regula22 tion, defines.

23 ‘‘IN VITRO DIAGNOSTIC TEST SYSTEM

24 ‘‘(m) Any laboratory licensed by the Secretary under

25 section 353 of the Public Health Services Act to perform

26 ‘high complexity’ testing which uses a special purpose rea-
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1 gent to manufacture an in vitro diagnostic test system

2 only for use in that laboratory shall validate the in vitro

3 diagnostic test system. The laboratory shall include the

4 following statement on all labeling and any patent test re5 port: ‘Proprietary assay developed and validated by øname

6 of laboratory¿. The performance characteristics of this

7 assay have not been cleared or approved by the Food and

8 Drug Administration’.’’.

9 SEC. 12. AUTHORIZATION OF NONGOVERNMENTAL ORGA10 NIZATIONS AND PERSONS TO CONDUCT

11 GOOD MANUFACTURING PRACTICE INSPEC12 TIONS AND RESPONSES TO ADVERSE FIND13 INGS.

14 Section 704 (21 U.S.C. 374) is amended—

15 (1) in subsection (a)(1), by inserting ‘‘or orga16 nizations and individuals receiving accreditation to

17 conduct good manufacturing practice inspections

18 under section 712’’ after ‘‘Secretary’’;

19 (2) in subsection (a)(3), by inserting ‘‘or an ac20 credited organization or individual under section

21 712’’ after ‘‘employee’’;

22 (3) in subsection (b), by inserting ‘‘, or the ac23 credited organization or individual under section

24 712,’’ after ‘‘employee’’;
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1 (4) in subsection (b), by inserting ‘‘(1)’’ after

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

3 (A) and (B), respectively, and adding at the end the

4 following:

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

6 from the date of presentation of the findings in paragraph

7 (1) for the person receiving such findings to respond. The

8 Secretary shall take no regulatory action against a person

9 or article subject to the requirements of the Act until com10 pleting a review of such a response, which is timely sub11 mitted to the Secretary, except the Secretary may take

12 immediate action when the Secretary finds that there is

13 a reasonable probability that a device intended for human

14 use would cause serious, adverse health consequences or

15 death, or that any regulated article could present an un16 reasonable and substantial risk of injury or illness to the

17 public health. The Secretary shall provide to the regulated

18 person, within 30 days of receiving a response to findings

19 identified in paragraph (1), a detailed assessment of the

20 response.

21 ‘‘(3) At the time an accredited organization or indi22 vidual shall identify in writing each inspectional finding

23 observed during such inspection which suggests a devi24 ation from requirements under the Act. Within 30 days

25 from the date of presentation of such findings, the person
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1 receiving the findings shall respond in writing to the ac2 credited organization or individual stating the response of

3 such person to each finding. Within 30 days of receipt of

4 such response, the accredited organization or individual

5 shall prepare and submit a written report to the Secretary,

6 including inspectional findings, the regulated person’s re7 sponse to the findings, an assessment of the adequacy of

8 the response and conclusions, and a copy of the conflict

9 of interest assessment prepared in accordance with the re10 quirement set forth in section 712(c). Such accredited or11 ganization or individual shall immediately submit to the

12 Secretary the inspectional findings when the device to

13 which such findings relate is intended for human use and

14 presents a reasonable probability that such device would

15 cause serious, adverse health consequences or death, or

16 that any regulated article could present an unreasonable

17 and substantial risk of injury or illness to the public

18 health.’’; and

19 (5) by adding after subsection (e) the following:

20 ‘‘(f) Persons duly designated by the Secretary to con21 duct inspections under this section shall not request any

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

23 unless such person states with specificity and in writing

24 the identification of the information subject to the request,

25 the reason for the request, and that the written request
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1 seeks to obtain information not required to be produced

2 under this section.’’.

3 SEC. 13. ACCREDITATION OF NONGOVERNMENTAL ORGANI4 ZATIONS OR INDIVIDUALS.

5 Subchapter A of chapter VII is amended by adding

6 the following:

7 ‘‘ACCREDITATION OF NONGOVERNMENTAL

8 ORGANIZATIONS OR INDIVIDUALS

9 ‘‘SEC. 712. (a) The Secretary shall, within 180 days

10 after the date of enactment of this section, by regulation

11 establish procedures and criteria to accredit any organiza12 tion or individuals for purposes of—

13 ‘‘(1) conducting good manufacturing practice

14 inspections authorized under section 704 to deter15 mine the conformance of a facility with regulations

16 promulgated under section 520(f);

17 ‘‘(2) reviewing notifications required under sec18 tion 510(k) and making written recommendations of

19 initial classification under section 513(f)(1) of de20 vices; and

21 ‘‘(3) reviewing applications under section 515(c)

22 and providing written reviews to the Secretary deter23 mine, within 120 days from the receipt of a submis24 sion requesting accreditation, whether the organiza25 tion or individual submitting such application is fit

26 to undertake some or all of the activities specifies
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1 herein. The Secretary shall notify the applicant in

2 writing of the Secretary’s determination within such

3 time period.

4 ‘‘(b) The Secretary shall take into account the train5 ing and experience of organizations and individuals who

6 apply for accreditation, including formal education, certifi7 cations, work experience, ability to protect the confiden8 tiality of trade secret and confidential commercial and fi9 nancial information, lack of bias and other related infor10 mation necessary to determine the fitness of an applicant

11 to undertake activities on behalf of the Department of

12 Health and Human Services.

13 ‘‘(c) Notwithstanding the credentials or qualifications

14 of any applicant, the Secretary shall, after accreditation

15 require each person who chooses to use an accredited orga16 nization or individual to determine whether such organiza17 tion or individual has a significant personal or financial

18 interest in a device, other than compensation for reviews

19 or inspections, that would influence decisions regarding

20 such device.’’.

21 SEC. 14. RESEARCH ACTIVITIES.

22 (a) ACTIVITIES.—Chapter IX, as amended by section

23 11, is amended by adding after section 906 the following:

24 ‘‘RESEARCH ACTIVITIES

25 ‘‘SEC. 907. Research activities of the Food and Drug

26 Administration relating to drugs, devices, and biological
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1 products, which are authorized under section

2 903(b)(2)(D) and section 352 of the Public Health Service

3 Act, shall directly relate to the review and approval of

4 drugs, devices, and biological products. In conducting such

5 research activities, the Food and Drug Administration

6 may collaborate with the National Institutes of Health,

7 academic health centers, and other scientific institutions

8 and the drug and device industry.’’.

9 (b) PURPOSE.—Section 903 (21 U.S.C. 393), as

10 amended by section 3, is amended by adding at the end

11 the following:

12 ‘‘(e) Any research conducted by or for the Food and

13 Drug Administration shall be solely related directly to (1)

14 the regulatory mission or (2) professional staff develop15 ment related to that mission and shall be limited to the

16 minimum necessary to achieve such purposes.’’.

17 SEC. 15. POLICY AND PERFORMANCE REVIEW.

18 Section 514 (21 U.S.C. 360d) is amended by adding

19 the following:

20 ‘‘(c)(1) The Secretary shall recognize applicable na21 tionally or internationally recognized consensus standards

22 to determine whether there is a reasonable assurance that

23 a device is safe or effective or to determine compliance

24 with any requirement under the Act, except that, any per25 son may elect to submit data other than that required by
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1 such standards to demonstrate a reasonable assurance of

2 device safety or effectiveness or compliance with require3 ments under the Act.

4 ‘‘(2) The Secretary in lieu of receiving data dem5 onstrating conformance to standards referenced in para6 graph (1) shall accept certifications from regulated per7 sons that devices conform with each standard identified

8 in each such certification.

9 ‘‘(d) The Secretary shall not rely upon informal agen10 cy statements, including guidance documents, policy state11 ments, points to consider documents, or any other state12 ments intended for a similar purpose, to require any ac13 tion be taken to satisfy a requirement under the Act, un14 less such statement is first subject to the rulemaking pro15 cedure set forth in section 5 U.S.C. e 553.’’.

16 SEC. 16. EXPORT OF NEW DRUGS AND DEVICES.

17 Section 801(e) (21 U.S.C. 381(e)) is amended—

18 (1) in paragraph (1), by inserting after ‘‘under

19 this Act’’ the following: ‘‘or in violation of section

20 505 or section 351 of the Public Health Service

21 Act’’,

22 (2) in paragraph (1), by striking the last sen23 tence, and

24 (3) by amending paragraph (2) to read as fol25 lows:
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1 ‘‘(2) Paragraph (1) does not apply to the export of—

2 ‘‘(A) any device—

3 ‘‘(i) which does not comply with an appli4 cable requirement under section 514 or 515,

5 ‘‘(ii) which under section 520(g) is exempt

6 from either such section, or

7 ‘‘(iii) which is a banned device under sec8 tion 516, or

9 ‘‘(B) any drug (including a biological product)

10 which does not comply with an applicable require11 ment under section 505 or 512 or section 351 of the

12 Public Health Service Act,

13 unless the device or drug is in compliance with the require14 ments of paragraph (1). In the case of a device or drug

15 for which an export notice is required under this para16 graph, the Secretary may prohibit the export of such de17 vice or drug if the Secretary determines that the possibil18 ity of the reimportation of the device or drug into the

19 United States presents an imminent hazard to the public

20 health and safety of the United States and the only means

21 of limiting the hazard is to prohibit the export of the de22 vice or drug.’’.

23 SEC. 17. RECLASSIFICATION OF CERTAIN DEVICES.

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

25 at the end the following new subsection:
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1 ‘‘RECLASSIFICATION

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

3 date of enactment of this subsection, publish in the Fed4 eral Register a proposed regulation reclassifying all de5 vices identified in subsection (i)(2) into class II, unless

6 the Secretary has already published a proposed regulation

7 required under subsection (i) for each such device. The

8 Secretary shall provide 60 days for comment on the pro9 posed regulation, and shall publish a final regulation in

10 the Federal Register within 60 days after the last day for

11 comment reclassifying into class II each such device not

12 included in a regulation required under subsection (i), or

13 maintaining, where appropriate, the original classification

14 of such devices.’’.

15 SEC. 18. TRACKING.

16 (a) Section 519(e) is amended to read as follows:

17 ‘‘(e) Every person who registers under section 510

18 and is engaged in the manufacture of a class II or class

19 III device the failure of which would be reasonably likely

20 to have life threatening or permanently debilitating health

21 consequences attributable to the device and which is a per22 manently implantable device, or a life sustaining or life

23 supporting device used outside a device user facility, or

24 may designate, shall adopt a method of device tracking.

25 Manufacturers subject to tracking may satisfy the require-
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1 ments of this subsection by relying exclusively on social

2 security numbers as a method of device tracking.’’.

3 (b) The Secretary of Health and Human Services

4 shall, within 12 months of the date of the enactment of

5 this Act, revise regulations appearing in part 821 of title

6 21 of the Code of Federal Regulations, to conform to sec7 tion 519 of the Federal Food, Drug, and Cosmetic Act

8 as amended by subsection (a).

9 (c) Section 205(c)(2)(C)(vii) (42 U.S.C. e

10 405(c)(2)(C)(viii)) of the Social Security Act is amended

11 by redesignating subclauses (II), (III), and (IV) as (III),

12 (IV), and (V), and inserting after subclause (I) the follow13 ing new subclause:

14 ‘‘(II) Section 519(e) of the Federal Food, Drug, and

15 Cosmetic Act (21 U.S.C. 360i(e)) is exempted from

16 subclause (I). Social Security account numbers and relat17 ed records obtained or maintained by authorized persons

18 shall be available for use under section 519(e) of the Fed19 eral Food, Drug, and Cosmetic Act (21 U.S.C. 360i(e))

20 for purposes of device tracking. The requirements under

21 section 7(b) of the Privacy Act of 1974 (Public Law No.

22 93–579, 88 Stat. 1896), shall not apply to any Federal,

23 State, or local government agency requesting a person to

24 disclose his/her social security account number for pur-
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1 poses of device tracking under section 519(e) of the Fed2 eral Food, Drug, and Cosmetic Act (21 U.S.C. 360i(e)).’’.

3 SEC. 19. POSTMARKET SURVEILLANCE.

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

5 follows:

6 ‘‘POSTMARKET SURVEILLANCE

7 ‘‘SEC. 522. (a) The Secretary may require a manu8 facturer to conduct postmarket surveillance for any device

9 of the manufacturer first introduced or delivered for intro10 duction into interstate commerce after January 1, 1991,

11 that is a class III device the failure of which would be

12 reasonably likely to have life threatening or permanently

13 debilitating consequences attributable to the device and

14 which is (1) a permanently implantable device, or (2) a

15 life sustaining or life supporting device used outside a de16 vice user facility.

17 ‘‘(b) Each manufacturer required to conduct a sur18 veillance of a device shall, within 30 days of receiving no19 tice from the Secretary that the manufacturer is required

20 under this section to conduct such surveillance and sub21 mit, for the approval of the Secretary, a protocol for the

22 required surveillance. The Secretary, within 60 days of the

23 receipt of such protocol, shall determine if the principal

24 investigator proposed to be used in the surveillance has

25 sufficient qualifications and experience to conduct such

26 surveillance and if such protocol will result in collection
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1 of useful data or other information necessary to protect

2 the public health and to provide safety and effectiveness

3 information for the device. The Secretary may not approve

4 such a protocol until it has been reviewed by an appro5 priately qualified scientific and technical review committee

6 established by the Secretary.’’.

7 SEC. 20. MISCELLANEOUS.

8 (a) Chapter III of the Federal Food, Drug, and Cos9 metic Act (21 U.S.C. 355 et seq.) is amended by adding

10 at the end thereof the following new sections:

11 ‘‘DISSEMINATION OF TREATMENT INFORMATION ON

12 DRUGS AND BIOLOGICAL PRODUCTS

13 ‘‘SEC. 311. (a)(1) Notwithstanding sections 301(d),

14 502(f), 505, and 507 and section 351 of the Public Health

15 Service Act (42 U.S.C. 262), and subject to the require16 ments of paragraph (2) and subsection (b), a person may

17 disseminate to any person that is a health care practi18 tioner or other provider of health care goods or services,

19 a pharmacy benefit manager, a health maintenance orga20 nization or other managed health care organization, or a

21 health care insurer or governmental agency, written infor22 mation, or an oral or written summary of the written in23 formation, concerning—

24 ‘‘(A) a treatment use for an investigational new

25 drug or an investigational biological product ap26 proved by the Secretary for such treatment use; or
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1 ‘‘(B) a use (whether or not such use is con2 tained in the official labeling) of a new drug (includ3 ing any antibiotic drug) or a biological product for

4 which an approval of an application filed under sec5 tion 505(b), 505(j), or 507, or a product license is6 sued under the Public Health Service Act, is in ef7 fect.

8 ‘‘(2) A person may disseminate information under

9 paragraph (1)(B) only if—

10 ‘‘(A) the information is an unabridged—

11 ‘‘(i) reprint or copy of a peer-reviewed arti12 cle from a scientific or medical journal that is

13 published by an organization that is independ14 ent of the pharmaceutical industry; or

15 ‘‘(ii) chapter, authored by an expert or ex16 perts in the disease to which the use relates,

17 from a recognized reference textbook that is

18 published by an organization that is independ19 ent of the pharmaceutical industry;

20 ‘‘(B) the text of the information has been ap21 proved by a continuing medical education accrediting

22 agency that is independent of the pharmaceutical in23 dustry as part of a scientific or medical educational

24 program approved by such agency;
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1 ‘‘(C) the information relates to a use that is

2 recognized under Federal law for purposes of third3 party coverage or reimbursement, and—

4 ‘‘(i) the text of the information has been

5 approved by an organization referred to in such

6 Federal law; or

7 ‘‘(ii) the information is part of a disease

8 management program or treatment guideline

9 with respect to such use; or

10 ‘‘(D) the information is an accurate and truth11 ful summary of the information described in sub12 paragraph (A), (B), or (C).

13 ‘‘(b) In order to afford a full and fair evaluation of

14 the information described in subsection (a), a person dis15 seminating the information shall include a statement that

16 discloses—

17 ‘‘(1) if applicable, that the use of a new drug

18 or biological product described in subparagraph (A)

19 or (B) of subsection (a)(1) and the information with

20 respect to the use have not been approved by the

21 Food and Drug Administration;

22 ‘‘(2) if applicable, that the information is being

23 disseminated at the expense of the sponsor of the

24 drug or biological product;
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1 ‘‘(3) if applicable, that one or more authors of

2 the information being disseminated are employees of

3 or consultants to the sponsor of the drug or biologi4 cal product; and

5 ‘‘(4) the official labeling for the drug and bio6 logical product, or in the case of a treatment use of

7 an investigational drug or biological product, the in8 vestigator brochure and all updates thereof.

9 ‘‘(c) As used in this section, the term ‘expense’ in10 cludes financial, in-kind, and other contributions provided

11 for the purpose of disseminating the information described

12 in subsection (a).

13 ‘‘(d) In the case of a professional disagreement be14 tween the Secretary and other qualified experts with re15 spect to the application of section 502(a), the Secretary

16 may not use section 502 to prohibit the dissemination of

17 information in the types of circumstances and under the

18 conditions set forth in subsections (a) and (b).

19 ‘‘DISSEMINATION OF INFORMATION ON DEVICES

20 SEC. 312. (a) Notwithstanding sections 301, 501(f),

21 501(i), 502(a), 502(f), and 502(o), or any other provision

22 of law, and subject to subsections (b) and (c), a person

23 may disseminate to any person that is a health care practi24 tioner or other provider of health care goods or services,

25 a pharmacy benefit manager, a health maintenance orga26 nization or other managed health care organization, or a
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1 health care insurer or governmental agency, written or

2 oral information (including information exchanged at sci3 entific and educational meetings, workshops, or dem4 onstrations) relating to a use, whether or not the use is

5 described in the official labeling, of a device produced by

6 a manufacturer registered pursuant to section 510.

7 ‘‘(b)(1) To the extent practicable, the requirement

8 with respect to a statement of disclosure under subsection

9 (b) of section 311 shall apply to the dissemination of writ10 ten and oral information under this section, except that

11 this paragraph shall not apply to the dissemination of

12 written or oral information with respect to the intended

13 use described in the labeling of a device.

14 ‘‘(2) A person may disseminate information under

15 subsection (a) only if—

16 ‘‘(A) the information is an unabridged—

17 ‘‘(i) reprint or copy of a peer-reviewed arti18 cle from a scientific or medical journal that is

19 published by an organization that is independ20 ent of the medical device industry; or

21 ‘‘(ii) chapter, authored by an expert or ex22 perts in the medical specialty to which the use

23 relates, from a recognized reference textbook

24 that is published by an organization that is

25 independent of the medical device industry;
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1 ‘‘(B) the information has been approved by a

2 continuing medical education accrediting agency that

3 is independent of the medical device industry as part

4 of a scientific or medical educational program ap5 proved by such agency;

6 ‘‘(C) the information relates to a use that is

7 recognized under Federal law for purposes of third8 party reimbursement, and—

9 ‘‘(i) the text of the information has been

10 approved by an organization referred to in such

11 Federal law; or

12 ‘‘(ii) the information is part of a disease

13 management program or treatment guideline

14 with respect to such use; or

15 ‘‘(D) the oral or written information is—

16 ‘‘(i) part of an exchange of information

17 solely among health care practitioners, health

18 care reimbursement officials, and the industry;

19 ‘‘(ii) exchanged for educational or scientific

20 purposes; and

21 ‘‘(iii) presented at continuing medical edu22 cation programs, seminars, workshops, or dem23 onstrations.
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1 ‘‘(3) The requirements under subsection (a)(1)(A)

2 and (B) of section 311 shall not apply with respect to de3 vices.

4 ‘‘(c) Notwithstanding section 502(a), 502(f), 502(o),

5 or any other provision of law, the written or oral dissemi6 nation of information relating to a new use of a device,

7 in accordance with this section, shall not be construed by

8 the Secretary as evidence of a new intended use of the

9 device that is different from the intended use of the device

10 set forth on the official labeling of the device. Such dis11 semination shall not be considered by the Secretary as la12 beling, adulteration, or misbranding of the device.’’.

13 (b) Section 519 (21 U.S.C. 360i) is amended to read

14 as follows:

15 ‘‘RECORDS AND REPORTS ON DEVICES

16 ‘‘SEC. 519. (a) Every person who is a manufacturer

17 or importer, of a device intended for human use shall es18 tablish and maintain such records, make such reports, and

19 provide such information, as the Secretary may by regula20 tion reasonably require to assure that such device is not

21 adulterated or misbranded and to otherwise assure its

22 safety and effectiveness. Regulations prescribed under the

23 preceding sentence—

24 ‘‘(1) shall require a device manufacturer or im25 porter to report to the Secretary whenever the man26 ufacturer or importer receives or otherwise becomes
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1 aware of information that reasonably suggests that

2 one of its marketed devices may have caused or con3 tributed to a death or serious injury;

4 ‘‘(2) shall define the term ‘serious injury’ to

5 mean an injury that—

6 ‘‘(A) is life threatening,

7 ‘‘(B) results in permanent impairment of a

8 body function or permanent damage to a body

9 structure, or

10 ‘‘(C) necessitates medical or surgical inter11 vention to preclude permanent impairment of a

12 body function or permanent damage to a body

13 structure;

14 ‘‘(3) shall require reporting of other significant

15 adverse device experiences as determined by the Sec16 retary to be necessary to be reported;

17 ‘‘(4) shall not impose requirements unduly bur18 densome to a device manufacturer or importer tak19 ing into account his cost of complying with such re20 quirements and the need for the protection of the

21 public health and the implementation of this Act;

22 ‘‘(5) which prescribe the procedure for making

23 requests for reports or information shall require that

24 each request made under such regulations for sub25 mission of a report or information to the Secretary
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1 state the reason or purpose for such request and

2 identify to the fullest extent practicable such report

3 or information;

4 ‘‘(6) which require submission of a report or in5 formation to the Secretary shall state the reason or

6 purpose for the submission of such report or infor7 mation and identify to the fullest extent practicable

8 such report or information;

9 ‘‘(7) may not require that the identity of any

10 patient be disclosed in records, reports, or informa11 tion required under this subsection unless required

12 for the medical welfare of an individual, to deter13 mine the safety or effectiveness of a device, or to

14 verify a record, report, or information submitted

15 under this Act;

16 ‘‘(8) may not require a manufacturer, importer,

17 or distributor of a class I device to—

18 ‘‘(A) maintain for such a device records re19 specting information not in the possession of

20 the manufacturer or importer, or

21 ‘‘(B) to submit for such a device to the

22 Secretary any report or information—

23 ‘‘(i) not in the possession of the man24 ufacturer or importer, or

25 ‘‘(ii) on a periodic basis,
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1 unless such report or information is necessary to de2 termine if the device should be reclassified or if the

3 device is adulterated or misbranded; and

4 ‘‘(b) Subsection (a) shall not apply to—

5 ‘‘(1) any practitioner who is licensed by law to

6 prescribe or administer devices intended for use in

7 humans and who manufactures or imports devices

8 solely for use in the course of his professional prac9 tice;

10 ‘‘(2) any person who manufactures or imports

11 devices intended for use in humans solely for such

12 person’s use in research or teaching and not for sale

13 (including any person who uses a device under an

14 exemption granted under section 520(g)); and

15 ‘‘(3) any other class of persons as the Secretary

16 may by regulation exempt from subsection (a) upon

17 a finding that compliance with the requirements of

18 such subsection by such class with respect to a de19 vice is not necessary to (A) assure that a device is

20 not adulterated or misbranded or (B) otherwise to

21 assure its safety and effectiveness.

22 ‘‘(c) Each manufacturer and importer required to

23 make reports under subsection (a) shall submit to the Sec24 retary annually a statement certifying that—
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1 ‘‘(1) the manufacturer or importer did file a

2 certain number of such reports, or

3 ‘‘(2) the manufacturer or importer did not file

4 any report under subsection (a).

5 ‘‘(d) Every person who registers under section 510

6 and is engaged in the manufacture of—

7 ‘‘(1) a device the failure of which would be rea8 sonably likely to have serious adverse health con9 sequences and which is (A) a permanently

10 implantable device, or (B) a life sustaining or life

11 supporting device used outside a device user facility,

12 or

13 ‘‘(2) any other device which the Secretary may

14 designate,

15 shall adopt a method of device tracking.’’.

16 (b) Within 120 days after the enactment of this sec17 tion, the Secretary shall delete all regulations in title 21,

18 part 800 requiring distributors, other than importers, to

19 make reports of deaths, serious injuries or illness, and

20 malfunctions related to devices.

21 (c) Section 303(c) (21 U.S.C. 333) is amended by

22 striking the period at the end of subsection (c) and insert23 ing ‘‘; or for having violated 301(a), (b), (c), and (k), by

24 failure to comply with either subsections 502(t)(2) or

25 501(h), or having violated subsection 301(g)(1)(B) by fail-
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1 ing to furnish material or information required under sub2 section 519(a) if such person acted in good faith, had no

3 reason to believe that the person’s acts violated the law,

4 and had no prior notice from the Secretary that the acts

5 constituted violations of the Act.’’.

6 (d) Section 201(h) (21 U.S.C. 321(h)) is amended

7 by striking paragraph (1), and renumbering paragraphs

8 (2), and (3) as paragraphs (1) and (2), respectively.

9 (e) The Secretary of Health and Human Services

10 within 120 days of the enactment of this section shall re11 vise all regulations appearing in part 800 of title 21 of

12 the Code of Federal Regulations to delete any requirement

13 to report device malfunctions.

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