II 

112TH CONGRESS 

1ST SESSION S. 1995 

To enhance Food and Drug Administration oversight of medical device recalls, 

to provide for the conditional clearance of certain medical devices, and 

for other purposes. 

IN THE SENATE OF THE UNITED STATES 

DECEMBER 14, 2011 

Mr. GRASSLEY (for himself, Mr. KOHL, and Mr. BLUMENTHAL) introduced 

the following bill; which was read twice and referred to the Committee 

on Health, Education, Labor, and Pensions 

A BILL 

To enhance Food and Drug Administration oversight of medical device recalls, to provide for the conditional clearance 

of certain medical devices, and for other purposes. 

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. 

4 This Act may be cited as the ‘‘Medical Device Patient 

5 Safety Act’’. 

6 SEC. 2. OVERSIGHT OF DEVICE RECALLS BY THE FOOD 

7 AND DRUG ADMINISTRATION. 

8 (a) DEFINITIONS.—In this Act: 


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1 (1) COMMISSIONER.—The term ‘‘Commis2 sioner’’ means the Commissioner of Food and 

3 Drugs. 

4 (2) DEVICE.—The term ‘‘device’’ has the mean5 ing given that term in section 201(h) of the Federal 

6 Food, Drug, and Cosmetic Act (21 U.S.C. 321(h)). 

7 (3) SECRETARY.—The term ‘‘Secretary’’ means 

8 the Secretary of Health and Human Services. 

9 (b) ACTIONS BY SECRETARY.—To enhance the over10 sight by the Food and Drug Administration of device re11 calls, the Secretary of Health and Human Services, acting 

12 through the Commissioner of Food and Drugs, shall carry 

13 out the activities described in this section. 

14 (c) ASSESSMENT OF DEVICE RECALL INFORMA15 TION.— 

16 (1) IN GENERAL.— 

17 (A) ASSESSMENT PROGRAM.—The Sec18 retary shall establish a program to routinely 

19 and systematically assess— 

20 (i) information submitted to the Sec21 retary pursuant to a device recall order 

22 under section 518(e) of the Federal Food, 

23 Drug, and Cosmetic Act (21 U.S.C. 

24 360h(e)); and 


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1 (ii) information required to be re2 ported to the Secretary regarding a correc3 tion or removal of a device under section 

4 519(g) of such Act (21 U.S.C. 360i(g)). 

5 (B) USE.—The Secretary shall use the as6 sessment of information described under sub7 paragraph (A) to proactively identify strategies 

8 for mitigating health risks presented by defec9 tive or unsafe devices. 

10 (2) DESIGN.—The program under paragraph 

11 (1) shall be designed, at a minimum, to identify— 

12 (A) trends in the numbers and types of de13 vice recalls; 

14 (B) the types of devices in each device 

15 class that are most frequently recalled; 

16 (C) the causes of device recalls; 

17 (D) the length of time needed for a person 

18 subject to a device recall to complete the recall; 

19 (E) the length of time needed for the Sec20 retary to terminate a device recall; 

21 (F) whether the Secretary has performed a 

22 device recall audit check; 

23 (G) which persons have been subject to the 

24 most device recalls; and 


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1 (H) any other information as the Secretary 

2 determines appropriate. 

3 (d) AUDIT CHECK PROCEDURES.—The Secretary 

4 shall clarify procedures for conducting device recall audit 

5 checks to improve the ability of investigators to perform 

6 these checks in a consistent manner. 

7 (e) ASSESSMENT CRITERIA.—The Secretary shall de8 velop explicit criteria for assessing whether a person sub9 ject to a recall order under section 518(e) of the Federal 

10 Food, Drug, and Cosmetic Act (21 U.S.C. 360h(e)) or to 

11 a requirement under section 519(g) of such Act (21 

12 U.S.C. 360i(g)) has performed an effective correction or 

13 removal action under such section 519(g). 

14 (f) TERMINATION OF RECALLS.— 

15 (1) IN GENERAL.—The Secretary shall docu16 ment the basis for the termination by the Food and 

17 Drug Administration of— 

18 (A) an individual device recall ordered 

19 under section 518(e) of the Federal Food, 

20 Drug, and Cosmetic Act (21 U.S.C. 360h(e)); 

21 and 

22 (B) the requirement on a manufacturer or 

23 importer of a device to report any correction or 

24 removal action for which a report is required to 


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1 be submitted to the Secretary under section 

2 519(g) of such Act (21 U.S.C. 360i(g)). 

3 (2) PUBLICATION.— 

4 (A) IN GENERAL.—The Secretary shall, 

5 with respect to each termination described in 

6 paragraph (1), publish the documentation re7 quired under such paragraph not later than 180 

8 days after such termination. 

9 (B) PROTECTION OF CONFIDENTIAL IN10 FORMATION OR TRADE SECRETS.—Before pub11 lic disclosure of the documentation under sub12 paragraph (A), the Secretary shall delete from 

13 the documentation the following: 

14 (i) Any information that constitutes 

15 trade secret or confidential commercial or 

16 financial information. 

17 (ii) Any personnel, medical, or similar 

18 information, including the serial numbers 

19 of implanted devices, which would con20 stitute a clearly unwarranted invasion of 

21 personal privacy. 


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1 SEC. 3. CONDITIONAL CLEARANCE OF CERTAIN MEDICAL 

2 DEVICES. 

3 (a) IN GENERAL.—Chapter V of the Federal Food, 

4 Drug, and Cosmetic Act (21 U.S.C. 351 et seq.) is amend5 ed by inserting after section 510 the following: 

6 ‘‘SEC. 510A. CONDITIONAL CLEARANCE OF CERTAIN MED7 ICAL DEVICES. 

8 ‘‘(a) IN GENERAL.—Notwithstanding any other pro9 vision of law, the Secretary may conditionally clear for in10 troduction into interstate commerce for commercial dis11 tribution a medical device intended for human use if such 

12 medical device is cleared pursuant to section 510(k). 

13 ‘‘(b) POSTCLEARANCE REQUIREMENTS.—As part of 

14 the conditional clearance under subsection (a), the Sec15 retary may impose the following: 

16 ‘‘(1) The Secretary may restrict the sale, dis17 tribution, or use of the device but only to the extent 

18 that the sale, distribution, or use of the device may 

19 be restricted pursuant to section 520(e). 

20 ‘‘(2) The Secretary— 

21 ‘‘(A) may require continuing evaluation 

22 and periodic reporting on the safety, effective23 ness, and reliability of the device for its in24 tended use; and 

25 ‘‘(B) shall, to the extent the Secretary 

26 makes a requirement under subparagraph (A), 


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1 state in the clearance order the reason or pur2 pose for such a requirement and the number of 

3 patients to be evaluated and the reports re4 quired to be submitted. 

5 ‘‘(3) The Secretary may require a prominent 

6 display in the labeling of the device and in the ad7 vertising of warnings, hazards, or precautions impor8 tant for the device’s safe and effective use, including 

9 patient information such as information provided to 

10 the patient on alternative modes of therapy and on 

11 risks and benefits associated with the use of the de12 vice. 

13 ‘‘(4) The Secretary— 

14 ‘‘(A) may require maintenance of records 

15 that will enable the applicant to submit to the 

16 Food and Drug Administration information 

17 needed to trace patients if such information is 

18 necessary to protect the public health; and 

19 ‘‘(B) shall, to the extent the Secretary 

20 makes the requirement under subparagraph 

21 (A), require that the identity of any patient be 

22 disclosed in records maintained under the 

23 postclearance reporting requirements only to 

24 the extent required for the medical welfare of 

25 the individual, to determine the safety or effecVerDate Mar 15 2010 03:13 Dec 21, 2011 Jkt 019200 PO 00000 Frm 00007 Fmt 6652 Sfmt 6201 E:\BILLS\S1995.IS S1995

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1 tiveness of the device, or to verify a record, re2 port, or information submitted to the agency. 

3 ‘‘(5) The Secretary may require maintenance of 

4 records for specified periods of time and organiza5 tion and indexing of records into identifiable files to 

6 enable the Food and Drug Administration to deter7 mine whether there is reasonable assurance of the 

8 continued safety and effectiveness of the device. 

9 ‘‘(6) The Secretary may require submission of 

10 periodic reports, at specified intervals, which reports 

11 shall comply with the following: 

12 ‘‘(A) Identify any of the following changes: 

13 ‘‘(i) New indications for use of the de14 vice. 

15 ‘‘(ii) Labeling changes. 

16 ‘‘(iii) The use of a different facility or 

17 establishment to manufacture, process, or 

18 package the device. 

19 ‘‘(iv) Changes in sterilization proce20 dures. 

21 ‘‘(v) Changes in packaging. 

22 ‘‘(vi) Changes in the performance or 

23 design specifications, circuits, components, 

24 ingredients, principle of operation, or phys25 ical layout of the device. 


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1 ‘‘(vii) Extension of the expiration date 

2 of the device based on data obtained under 

3 a new or revised stability or sterility test4 ing protocol. 

5 ‘‘(viii) A change that does not affect 

6 the device’s safety or effectiveness. 

7 ‘‘(B) Contain a summary and bibliography 

8 of the following information not previously sub9 mitted: 

10 ‘‘(i) Unpublished reports of data from 

11 any clinical investigations or nonclinical 

12 laboratory studies involving the device or 

13 related devices and known to or that rea14 sonably should be known to the applicant. 

15 ‘‘(ii) Reports in the scientific lit16 erature concerning the device and known 

17 to or that reasonably should be known to 

18 the applicant. If, after reviewing the sum19 mary and bibliography, the Food and Drug 

20 Administration concludes that the agency 

21 needs a copy of the unpublished or pub22 lished reports, the Food and Drug Admin23 istration shall notify the applicant that 

24 copies of such reports should be submitted. 


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1 ‘‘(C) Identify changes made pursuant to an 

2 exception or alternative granted under section 

3 801.128 or 809.11 of title 21, Code of Federal 

4 Regulations. 

5 ‘‘(7) The Secretary may require batch testing of 

6 the device. 

7 ‘‘(8) The Secretary may provide for any other 

8 requirements determined by the Secretary to be nec9 essary to provide reasonable assurance, or continued 

10 reasonable assurance, of the safety and effectiveness 

11 of the device. 

12 ‘‘(9) The Secretary may require device tracking 

13 as provided under part 821 of title 21, Code of Fed14 eral Regulations. 

15 ‘‘(c) RESCISSION OF CONDITIONAL CLEARANCE.— 

16 The Secretary may rescind the conditional clearance of a 

17 medical device under subsection (a) if the Secretary deter18 mines that the conditions imposed on the clearance of the 

19 device described in subsection (b) have not been met.’’. 

20 (b) CIVIL MONETARY PENALTIES.—Section 

21 303(f)(1)(A) of the Federal Food, Drug, and Cosmetic Act 

22 (21 U.S.C. 333(f)(1)(A)) is amended by inserting ‘‘, or 

23 a regulation promulgated or an order issued to carry out 

24 this Act,’’ after ‘‘any person who violates a requirement 

25 of this Act’’. 


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1 (c) PROCESS FOR THE REVIEW OF DEVICE APPLICA2 TIONS.—Section 737(8)(J) of the Federal Food, Drug, 

3 and Cosmetic Act (21 U.S.C. 379i(8)(J)) is amended by 

4 inserting ‘‘or required as a condition of clearance of a de5 vice under section 510A’’ after ‘‘Act’’. 

Æ 


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