S 1995 ISCommentsClose CommentsPermalink

112th CONGRESSCommentsClose CommentsPermalink

1st SessionCommentsClose CommentsPermalink

S. 1995CommentsClose CommentsPermalink

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.CommentsClose CommentsPermalink

IN THE SENATE OF THE UNITED STATESCommentsClose CommentsPermalink

December 14, 2011CommentsClose CommentsPermalink

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 PensionsCommentsClose CommentsPermalink

A BILLCommentsClose CommentsPermalink

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.CommentsClose CommentsPermalink

Be it enacted by the Senate and House of Representatives of the United States of America in Congress assembled,CommentsClose CommentsPermalink

SECTION 1. SHORT TITLE.

This Act may be cited as the ‘Medical Device Patient Safety Act’.CommentsClose CommentsPermalink

SEC. 2. OVERSIGHT OF DEVICE RECALLS BY THE FOOD AND DRUG ADMINISTRATION.

(a) Definitions- In this Act:CommentsClose CommentsPermalink





(1) COMMISSIONER- The term ‘Commissioner’ means the Commissioner of Food and Drugs.CommentsClose CommentsPermalink





(2) DEVICE- The term ‘device’ has the meaning given that term in section 201(h) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321(h)).CommentsClose CommentsPermalink





(3) SECRETARY- The term ‘Secretary’ means the Secretary of Health and Human Services.CommentsClose CommentsPermalink





(b) Actions by Secretary- To enhance the oversight by the Food and Drug Administration of device recalls, the Secretary of Health and Human Services, acting through the Commissioner of Food and Drugs, shall carry out the activities described in this section.CommentsClose CommentsPermalink





(c) Assessment of Device Recall Information-CommentsClose CommentsPermalink





(1) IN GENERAL-CommentsClose CommentsPermalink





(A) ASSESSMENT PROGRAM- The Secretary shall establish a program to routinely and systematically assess--CommentsClose CommentsPermalink





(i) information submitted to the Secretary pursuant to a device recall order under section 518(e) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360h(e)); andCommentsClose CommentsPermalink





(ii) information required to be reported to the Secretary regarding a correction or removal of a device under section 519(g) of such Act (21 U.S.C. 360i(g)).CommentsClose CommentsPermalink





(B) USE- The Secretary shall use the assessment of information described under subparagraph (A) to proactively identify strategies for mitigating health risks presented by defective or unsafe devices.CommentsClose CommentsPermalink





(2) DESIGN- The program under paragraph (1) shall be designed, at a minimum, to identify--CommentsClose CommentsPermalink





(A) trends in the numbers and types of device recalls;CommentsClose CommentsPermalink





(B) the types of devices in each device class that are most frequently recalled;CommentsClose CommentsPermalink





(C) the causes of device recalls;CommentsClose CommentsPermalink





(D) the length of time needed for a person subject to a device recall to complete the recall;CommentsClose CommentsPermalink





(E) the length of time needed for the Secretary to terminate a device recall;CommentsClose CommentsPermalink





(F) whether the Secretary has performed a device recall audit check;CommentsClose CommentsPermalink





(G) which persons have been subject to the most device recalls; andCommentsClose CommentsPermalink





(H) any other information as the Secretary determines appropriate.CommentsClose CommentsPermalink





(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.CommentsClose CommentsPermalink





(e) Assessment Criteria- The Secretary shall develop explicit criteria for assessing whether a person subject 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).CommentsClose CommentsPermalink





(f) Termination of Recalls-CommentsClose CommentsPermalink





(1) IN GENERAL- The Secretary shall document the basis for the termination by the Food and Drug Administration of--CommentsClose CommentsPermalink





(A) an individual device recall ordered under section 518(e) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360h(e)); andCommentsClose CommentsPermalink





(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 be submitted to the Secretary under section 519(g) of such Act (21 U.S.C. 360i(g)).CommentsClose CommentsPermalink





(2) PUBLICATION-CommentsClose CommentsPermalink





(A) IN GENERAL- The Secretary shall, with respect to each termination described in paragraph (1), publish the documentation required under such paragraph not later than 180 days after such termination.CommentsClose CommentsPermalink





(B) PROTECTION OF CONFIDENTIAL INFORMATION OR TRADE SECRETS- Before public disclosure of the documentation under subparagraph (A), the Secretary shall delete from the documentation the following:CommentsClose CommentsPermalink





(i) Any information that constitutes trade secret or confidential commercial or financial information.CommentsClose CommentsPermalink





(ii) Any personnel, medical, or similar information, including the serial numbers of implanted devices, which would constitute a clearly unwarranted invasion of personal privacy.CommentsClose CommentsPermalink

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 amended by inserting after section 510 the following:CommentsClose CommentsPermalink

‘SEC. 510A. CONDITIONAL CLEARANCE OF CERTAIN MEDICAL DEVICES.

‘(a) In General- Notwithstanding any other provision of law, the Secretary may conditionally clear for introduction into interstate commerce for commercial distribution a medical device intended for human use if such medical device is cleared pursuant to section 510(k).CommentsClose CommentsPermalink





‘(b) Postclearance Requirements- As part of the conditional clearance under subsection (a), the Secretary may impose the following:CommentsClose CommentsPermalink





‘(1) The Secretary may restrict the sale, distribution, 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).CommentsClose CommentsPermalink





‘(2) The Secretary--CommentsClose CommentsPermalink





‘(A) may require continuing evaluation and periodic reporting on the safety, effectiveness, and reliability of the device for its intended use; andCommentsClose CommentsPermalink





‘(B) shall, to the extent the Secretary makes a requirement under subparagraph (A), state in the clearance order the reason or purpose for such a requirement and the number of patients to be evaluated and the reports required to be submitted.CommentsClose CommentsPermalink





‘(3) The Secretary may require a prominent display in the labeling of the device and in the advertising of warnings, hazards, or precautions important 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 device.CommentsClose CommentsPermalink





‘(4) The Secretary--CommentsClose CommentsPermalink





‘(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; andCommentsClose CommentsPermalink





‘(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 effectiveness of the device, or to verify a record, report, or information submitted to the agency.CommentsClose CommentsPermalink





‘(5) The Secretary may require maintenance of records for specified periods of time and organization and indexing of records into identifiable files to enable the Food and Drug Administration to determine whether there is reasonable assurance of the continued safety and effectiveness of the device.CommentsClose CommentsPermalink





‘(6) The Secretary may require submission of periodic reports, at specified intervals, which reports shall comply with the following:CommentsClose CommentsPermalink





‘(A) Identify any of the following changes:CommentsClose CommentsPermalink





‘(i) New indications for use of the device.CommentsClose CommentsPermalink





‘(ii) Labeling changes.CommentsClose CommentsPermalink





‘(iii) The use of a different facility or establishment to manufacture, process, or package the device.CommentsClose CommentsPermalink





‘(iv) Changes in sterilization procedures.CommentsClose CommentsPermalink





‘(v) Changes in packaging.CommentsClose CommentsPermalink





‘(vi) Changes in the performance or design specifications, circuits, components, ingredients, principle of operation, or physical layout of the device.CommentsClose CommentsPermalink





‘(vii) Extension of the expiration date of the device based on data obtained under a new or revised stability or sterility testing protocol.CommentsClose CommentsPermalink





‘(viii) A change that does not affect the device’s safety or effectiveness.CommentsClose CommentsPermalink





‘(B) Contain a summary and bibliography of the following information not previously submitted:CommentsClose CommentsPermalink





‘(i) Unpublished reports of data from any clinical investigations or nonclinical laboratory studies involving the device or related devices and known to or that reasonably should be known to the applicant.CommentsClose CommentsPermalink





‘(ii) Reports in the scientific literature concerning the device and known to or that reasonably should be known to the applicant. If, after reviewing the summary and bibliography, the Food and Drug Administration concludes that the agency needs a copy of the unpublished or published reports, the Food and Drug Administration shall notify the applicant that copies of such reports should be submitted.CommentsClose CommentsPermalink





‘(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.CommentsClose CommentsPermalink





‘(7) The Secretary may require batch testing of the device.CommentsClose CommentsPermalink





‘(8) The Secretary may provide for any other requirements determined by the Secretary to be necessary to provide reasonable assurance, or continued reasonable assurance, of the safety and effectiveness of the device.CommentsClose CommentsPermalink





‘(9) The Secretary may require device tracking as provided under part 821 of title 21, Code of Federal Regulations.CommentsClose CommentsPermalink





‘(c) Rescission of Conditional Clearance- The Secretary may rescind the conditional clearance of a medical device under subsection (a) if the Secretary determines that the conditions imposed on the clearance of the device described in subsection (b) have not been met.’.CommentsClose CommentsPermalink





(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’.CommentsClose CommentsPermalink





(c) Process for the Review of Device Applications- 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 device under section 510A’ after ‘Act’.CommentsClose CommentsPermalink