I 

115TH CONGRESS 

1ST SESSION H. R. 1736 

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

for inspections of device establishments and for granting export certifications. 

IN THE HOUSE OF REPRESENTATIVES 

MARCH 27, 2017 

Mr. BUCSHON (for himself, Mrs. BROOKS of Indiana, Mr. PETERS, and Mr. 

BUTTERFIELD) introduced the following bill; which was referred to the 

Committee on Energy and Commerce 

A BILL 

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

improve the process for inspections of device establishments and for granting export certifications. 

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

3 SECTION 1. FINDINGS. 

4 Congress finds as follows: 

5 (1) There is a lack of transparency and consist6 ency concerning inspections by the Food and Drug 

7 Administration of medical device establishments 

8 around the world, which leads to inefficiencies and 


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1 inconsistencies and undermines confidence in United 

2 States standards. 

3 (2) Inspections by the Food and Drug Adminis4 tration of foreign device establishments are often 

5 conducted more efficiently than inspections of do6 mestic device establishments. 

7 (3) The frequency and nature of inspections of 

8 device establishments are not consistently risk-based, 

9 and a comprehensive, transparent, risk-based ap10 proach to inspections would result in greater focus 

11 on the more significant risks to public health while 

12 reducing the burdens on establishments with a 

13 strong track record of compliance. 

14 (4) There is a lack of transparency and consist15 ency among United States-based regional inspection 

16 offices with respect to the frequency of inspections 

17 of device establishments and the activities and con18 cerns that trigger for-cause inspections of such es19 tablishments. 

20 (5) Greater transparency concerning the timing 

21 and nature of routine inspections of device establish22 ments would improve the quality and efficiency of 

23 the inspection process. 

24 (6) Enhancing communications before, during, 

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1 fied, would assist the Secretary of Health and 

2 Human Services and the device industry in main3 taining the safety and effectiveness of devices. 

4 (7) Guidance for device establishments is nec5 essary to provide transparency and consistency con6 cerning inspection-related communications. 

7 (8) Enhanced training opportunities for device 

8 establishment investigators would improve the con9 sistency and efficiency of the device inspection proc10 ess. 

11 (9) There is a lack of transparency in the ex12 port certification process with respect to device es13 tablishments for which FDA Form 483 has been 

14 used to document issues noticed during an inspec15 tion conducted pursuant to section 704 of the Fed16 eral Food, Drug, and Cosmetic Act (21 U.S.C. 374) 

17 or establishments that have received Warning Let18 ters in connection with such an inspection, and be19 tween domestic and foreign establishments, resulting 

20 in devices that are lawfully marketed for United 

21 States patients being denied certification for mar22 keting in other countries. 

23 (10) Device establishments that have attempted 

24 to address deficiencies identified by inspections car25 ried out by the Food and Drug Administration lack 


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1 sufficient opportunities to confirm that such correc2 tive actions are appropriate. 

3 SEC. 2. RISK-BASED INSPECTIONS FOR DEVICES. 

4 Paragraph (2) of section 510(h) of the Federal Food, 

5 Drug, and Cosmetic Act (21 U.S.C. 360(h)) is amended 

6 to read as follows: 

7 ‘‘(2) RISK-BASED SCHEDULE FOR DEVICES.— 

8 ‘‘(A) IN GENERAL.—The Secretary, acting 

9 through one or more officers or employees duly 

10 designated by the Secretary, shall inspect estab11 lishments described in paragraph (1) that are 

12 engaged in the manufacture, propagation, 

13 compounding, or processing of a device or de14 vices (referred to in this subsection as ‘device 

15 establishments’) in accordance with one risk16 based inspection schedule established by the 

17 Secretary, applied consistently across regional 

18 offices. 

19 ‘‘(B) FACTORS AND CONSIDERATIONS.—In 

20 establishing the risk-based schedule under sub21 paragraph (A), the Secretary shall— 

22 ‘‘(i) apply, to the extent applicable for 

23 device establishments, the factors identified 

24 in paragraph (4); and 


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1 ‘‘(ii) consider the participation of the 

2 device establishment, as applicable, in 

3 international device audit programs in 

4 which the United States participates or the 

5 United States recognizes for purposes of 

6 inspecting.’’. 

7 SEC. 3. IMPROVEMENTS TO INSPECTIONS PROCESS FOR 

8 DEVICE ESTABLISHMENTS. 

9 Section 704 of the Federal Food, Drug, and Cosmetic 

10 Act (21 U.S.C. 374) is amended by adding at the end the 

11 following: 

12 ‘‘(h)(1) The Secretary shall adopt a uniform process 

13 and uniform standards applicable to inspections of domes14 tic and foreign device establishments. Such process shall 

15 include— 

16 ‘‘(A) notifying the owner, operator, or agent in 

17 charge of the establishment of the type and nature 

18 of the inspection; 

19 ‘‘(B) announcing the inspection the establish20 ment within a reasonable time before such inspec21 tion; 

22 ‘‘(C) in the case of inspections other than for23 cause inspections, providing a reasonable estimate of 

24 the timeframe for the inspection, an opportunity for 

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1 ployees carrying out the inspection under subsection 

2 (a)(1) and the owner, operator, or agent in charge 

3 of the establishment concerning appropriate working 

4 hours during the inspection, and, to the extent fea5 sible, advance notice of records that will be re6 quested in order to expedite the inspection; and 

7 ‘‘(D) daily communications with the owner, op8 erator, or agent in charge of the establishment re9 garding inspection status, which may be recorded by 

10 either party with advance notice. 

11 ‘‘(2) In the case of device establishments that have 

12 received a report pursuant to subsection (b), and for which 

13 the owner, operator, or agent in charge of such establish14 ment submits a timely response to such report that in15 cludes a request for feedback to the actions proposed in 

16 such response, the Secretary shall provide nonbinding 

17 feedback regarding such proposed actions within 45 days 

18 of receipt of such request. 

19 ‘‘(3) Nothing in this subsection limits the authority 

20 of the Secretary to conduct inspections otherwise per21 mitted under this Act in order to ensure compliance with 

22 this Act. 

23 ‘‘(4)(A) Not later than 1 year after the date of enact24 ment of this subsection, the Secretary shall issue draft 

25 guidance that— 


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1 ‘‘(i) specifies how the Food and Drug Adminis2 tration will implement the process described in para3 graph (1) and the requirements described in para4 graph (2); 

5 ‘‘(ii) provides for standardized templates for 

6 communications described in such paragraphs; 

7 ‘‘(iii) establishes a standard timeframe over 

8 consecutive days that is applicable to both domestic 

9 and foreign inspections, to which each inspector 

10 shall adhere unless an investigator can identify to 

11 the establishment a reason that more time is needed; 

12 and 

13 ‘‘(iv) identifies practices for investigators and 

14 device establishments to facilitate the continuity of 

15 inspections. 

16 ‘‘(B) Not later than 18 months after the date of en17 actment of this subsection, after notice and opportunity 

18 for public comment on the draft guidance described in 

19 subparagraph (A), the Secretary shall issue final guidance 

20 consistent with this subsection.’’. 

21 SEC. 4. CERTIFICATES TO FOREIGN GOVERNMENTS FOR 

22 DEVICES. 

23 Subsection (e)(4) of section 801 of the Federal Food, 

24 Drug, and Cosmetic Act (21 U.S.C. 381(e)(4)) is amend25 ed— 


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1 (1) by adding at the end the following: 

2 ‘‘(E)(i) If the Secretary denies a request for certifi3 cation with respect to a device pursuant to subparagraph 

4 (A)(ii), the Secretary shall provide in writing to the person 

5 seeking such certification the basis for such denial, and 

6 specifically identify the finding upon which such denial is 

7 based. 

8 ‘‘(ii) If the denial of a request as described in clause 

9 (i) is based on grounds other than an injunction pro10 ceeding pursuant to section 302, seizure action pursuant 

11 to section 304, or a recall designated Class I or Class II 

12 pursuant to part 7, title 21, Code of Federal Regulations, 

13 the Secretary shall provide a substantive summary of the 

14 specific deficiencies identified. 

15 ‘‘(iii) With respect to a device manufactured in an 

16 establishment that has received a report under section 

17 704(b), the Secretary shall not deny a request for certifi18 cation with respect to a device pursuant to subparagraph 

19 (A)(ii) if the Secretary and the owner, operator, or agent 

20 in charge of such establishment have agreed to a plan of 

21 correction in response to such report. 

22 ‘‘(F)(i) The Secretary shall provide a process for a 

23 person who is denied a certification as described in sub24 paragraph (E)(i) to request a review that conforms to the 

25 standards of section 517A(b). 


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1 ‘‘(ii) Notwithstanding any previous review conducted 

2 pursuant to clause (i), a person who has been denied a 

3 certification as described in subparagraph (E)(i) may at 

4 any time request a review in order to present new informa5 tion relating to actions taken by such person to address 

6 the reasons identified by the Secretary for the denial of 

7 certification, including corrective actions to address defi8 ciencies identified by the Secretary. 

9 ‘‘(iii) Not later than 1 year after date of enactment 

10 of this subparagraph, the Secretary shall issue guidance 

11 providing for a process to carry out this subparagraph. 

12 ‘‘(G)(i) Subparagraphs (E) and (F) apply to requests 

13 for certification on behalf of any device establishment reg14 istered under section 510, whether the establishment is 

15 located in the United States or another country. 

16 ‘‘(ii) The Secretary may charge a fee for the issuance 

17 of a certification described in clause (i), and such fee is 

18 subject to the conditions and requirements of subpara19 graph (B).’’; and 

20 (2) by moving the margins of subparagraphs 

21 (C) and (D) 4 ems to the left. 

Æ 


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