I 
112TH CONGRESS 
2D SESSION 
H. R. 5866 
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 HOUSE OF REPRESENTATIVES 
MAY 30, 2012 
Mr. BRALEY of Iowa introduced the following bill; which was referred to the 
Committee on Energy and Commerce 
A BILL 
To enhance Food and Drug Administration oversight of med-
ical device recalls, to provide for the conditional clearance 
of certain medical devices, and for other purposes. 
Be it enacted by the Senate and House of Representa-
tives of the United States of America in Congress assembled, 
SECTION 1. SHORT TITLE. 
This Act may be cited as the ‘‘Medical Device Patient 
Safety Act’’. 
SEC. 2. OVERSIGHT OF DEVICE RECALLS BY THE FOOD 
AND DRUG ADMINISTRATION. 
(a) DEFINITIONS.—In this Act: 
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(1) 
COMMISSIONER.—The 
term 
‘‘Commis-
sioner’’ means the Commissioner of Food and 
Drugs. 
(2) DEVICE.—The term ‘‘device’’ has the mean-
ing given that term in section 201(h) of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 321(h)). 
(3) SECRETARY.—The term ‘‘Secretary’’ means 
the Secretary of Health and Human Services. 
(b) ACTIONS BY SECRETARY.—To enhance the over-
sight by the Food and Drug Administration of device re-
calls, the Secretary of Health and Human Services, acting 
through the Commissioner of Food and Drugs, shall carry 
out the activities described in this section. 
(c) ASSESSMENT
OF DEVICE RECALL INFORMA-
TION.— 
(1) IN GENERAL.— 
(A) ASSESSMENT
PROGRAM.—The Sec-
retary shall establish a program to routinely 
and systematically assess— 
(i) information submitted to the Sec-
retary pursuant to a device recall order 
under section 518(e) of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 
360h(e)); and 
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(ii) information required to be re-
ported to the Secretary regarding a correc-
tion or removal of a device under section 
519(g) of such Act (21 U.S.C. 360i(g)). 
(B) USE.—The Secretary shall use the as-
sessment of information described under sub-
paragraph (A) to proactively identify strategies 
for mitigating health risks presented by defec-
tive or unsafe devices. 
(2) DESIGN.—The program under paragraph 
(1) shall be designed, at a minimum, to identify— 
(A) trends in the numbers and types of de-
vice recalls; 
(B) the types of devices in each device 
class that are most frequently recalled; 
(C) the causes of device recalls; 
(D) the length of time needed for a person 
subject to a device recall to complete the recall; 
(E) the length of time needed for the Sec-
retary to terminate a device recall; 
(F) whether the Secretary has performed a 
device recall audit check; 
(G) which persons have been subject to the 
most device recalls; and 
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(H) any other information as the Secretary 
determines appropriate. 
(d) AUDIT CHECK PROCEDURES.—The Secretary 
shall clarify procedures for conducting device recall audit 
checks to improve the ability of investigators to perform 
these checks in a consistent manner. 
(e) ASSESSMENT CRITERIA.—The Secretary shall de-
velop explicit criteria for assessing whether a person sub-
ject to a recall order under section 518(e) of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 360h(e)) or to 
a requirement under section 519(g) of such Act (21 
U.S.C. 360i(g)) has performed an effective correction or 
removal action under such section 519(g). 
(f) TERMINATION OF RECALLS.— 
(1) IN GENERAL.—The Secretary shall docu-
ment the basis for the termination by the Food and 
Drug Administration of— 
(A) an individual device recall ordered 
under section 518(e) of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 360h(e)); 
and 
(B) the requirement on a manufacturer or 
importer of a device to report any correction or 
removal action for which a report is required to 
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be submitted to the Secretary under section 
519(g) of such Act (21 U.S.C. 360i(g)). 
(2) PUBLICATION.— 
(A) IN
GENERAL.—The Secretary shall, 
with respect to each termination described in 
paragraph (1), publish the documentation re-
quired under such paragraph not later than 180 
days after such termination. 
(B) PROTECTION
OF
CONFIDENTIAL
IN-
FORMATION OR TRADE SECRETS.—Before pub-
lic disclosure of the documentation under sub-
paragraph (A), the Secretary shall delete from 
the documentation the following: 
(i) Any information that constitutes 
trade secret or confidential commercial or 
financial information. 
(ii) Any personnel, medical, or similar 
information, including the serial numbers 
of implanted devices, which would con-
stitute a clearly unwarranted invasion of 
personal privacy. 
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SEC. 3. CONDITIONAL CLEARANCE OF CERTAIN MEDICAL 
DEVICES. 
(a) IN GENERAL.—Chapter V of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 351 et seq.) is amend-
ed by inserting after section 510 the following: 
‘‘SEC. 510A. CONDITIONAL CLEARANCE OF CERTAIN MED-
ICAL DEVICES. 
‘‘(a) IN GENERAL.—Notwithstanding any other pro-
vision of law, the Secretary may conditionally clear for in-
troduction into interstate commerce for commercial dis-
tribution a medical device intended for human use if such 
medical device is cleared pursuant to section 510(k). 
‘‘(b) POSTCLEARANCE REQUIREMENTS.—As part of 
the conditional clearance under subsection (a), the Sec-
retary may impose the following: 
‘‘(1) The Secretary may restrict the sale, dis-
tribution, or use of the device but only to the extent 
that the sale, distribution, or use of the device may 
be restricted pursuant to section 520(e). 
‘‘(2) The Secretary— 
‘‘(A) may require continuing evaluation 
and periodic reporting on the safety, effective-
ness, and reliability of the device for its in-
tended use; and 
‘‘(B) shall, to the extent the Secretary 
makes a requirement under subparagraph (A), 
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state in the clearance order the reason or pur-
pose for such a requirement and the number of 
patients to be evaluated and the reports re-
quired to be submitted. 
‘‘(3) The Secretary may require a prominent 
display in the labeling of the device and in the ad-
vertising of warnings, hazards, or precautions impor-
tant for the device’s safe and effective use, including 
patient information such as information provided to 
the patient on alternative modes of therapy and on 
risks and benefits associated with the use of the de-
vice. 
‘‘(4) The Secretary— 
‘‘(A) may require maintenance of records 
that will enable the applicant to submit to the 
Food and Drug Administration information 
needed to trace patients if such information is 
necessary to protect the public health; and 
‘‘(B) shall, to the extent the Secretary 
makes the requirement under subparagraph 
(A), require that the identity of any patient be 
disclosed in records maintained under the 
postclearance reporting requirements only to 
the extent required for the medical welfare of 
the individual, to determine the safety or effec-
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tiveness of the device, or to verify a record, re-
port, or information submitted to the agency. 
‘‘(5) The Secretary may require maintenance of 
records for specified periods of time and organiza-
tion and indexing of records into identifiable files to 
enable the Food and Drug Administration to deter-
mine whether there is reasonable assurance of the 
continued safety and effectiveness of the device. 
‘‘(6) The Secretary may require submission of 
periodic reports, at specified intervals, which reports 
shall comply with the following: 
‘‘(A) Identify any of the following changes: 
‘‘(i) New indications for use of the de-
vice. 
‘‘(ii) Labeling changes. 
‘‘(iii) The use of a different facility or 
establishment to manufacture, process, or 
package the device. 
‘‘(iv) Changes in sterilization proce-
dures. 
‘‘(v) Changes in packaging. 
‘‘(vi) Changes in the performance or 
design specifications, circuits, components, 
ingredients, principle of operation, or phys-
ical layout of the device. 
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‘‘(vii) Extension of the expiration date 
of the device based on data obtained under 
a new or revised stability or sterility test-
ing protocol. 
‘‘(viii) A change that does not affect 
the device’s safety or effectiveness. 
‘‘(B) Contain a summary and bibliography 
of the following information not previously sub-
mitted: 
‘‘(i) Unpublished reports of data from 
any clinical investigations or nonclinical 
laboratory studies involving the device or 
related devices and known to or that rea-
sonably should be known to the applicant. 
‘‘(ii) Reports in the scientific lit-
erature concerning the device and known 
to or that reasonably should be known to 
the applicant. If, after reviewing the sum-
mary and bibliography, the Food and Drug 
Administration concludes that the agency 
needs a copy of the unpublished or pub-
lished reports, the Food and Drug Admin-
istration shall notify the applicant that 
copies of such reports should be submitted. 
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‘‘(C) Identify changes made pursuant to an 
exception or alternative granted under section 
801.128 or 809.11 of title 21, Code of Federal 
Regulations. 
‘‘(7) The Secretary may require batch testing of 
the device. 
‘‘(8) The Secretary may provide for any other 
requirements determined by the Secretary to be nec-
essary to provide reasonable assurance, or continued 
reasonable assurance, of the safety and effectiveness 
of the device. 
‘‘(9) The Secretary may require device tracking 
as provided under part 821 of title 21, Code of Fed-
eral Regulations. 
‘‘(c) RESCISSION OF CONDITIONAL CLEARANCE.— 
The Secretary may rescind the conditional clearance of a 
medical device under subsection (a) if the Secretary deter-
mines that the conditions imposed on the clearance of the 
device described in subsection (b) have not been met.’’. 
(b) 
CIVIL
MONETARY
PENALTIES.—Section 
303(f)(1)(A) of the Federal Food, Drug, and Cosmetic Act 
(21 U.S.C. 333(f)(1)(A)) is amended by inserting ‘‘, or 
a regulation promulgated or an order issued to carry out 
this Act,’’ after ‘‘any person who violates a requirement 
of this Act’’. 
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(c) PROCESS FOR THE REVIEW OF DEVICE APPLICA-
TIONS.—Section 737(8)(J) of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 379i(8)(J)) is amended by 
inserting ‘‘or required as a condition of clearance of a de-
vice under section 510A’’ after ‘‘Act’’. 
Æ 
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