[Congressional Bills 112th Congress]
[From the U.S. Government Publishing Office]
[S. 1995 Introduced in Senate (IS)]

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.

    Be it enacted by the Senate and House of Representatives 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:
            (1) Commissioner.--The term ``Commissioner'' means the 
        Commissioner of Food and Drugs.
            (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)).
            (3) Secretary.--The term ``Secretary'' means the Secretary 
        of Health and Human Services.
    (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.
    (c) Assessment of Device Recall Information.--
            (1) In general.--
                    (A) Assessment program.--The Secretary shall 
                establish a program to routinely and systematically 
                assess--
                            (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)); and
                            (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)).
                    (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.
            (2) Design.--The program under paragraph (1) shall be 
        designed, at a minimum, to identify--
                    (A) trends in the numbers and types of device 
                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 Secretary 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
                    (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 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).
    (f) Termination of Recalls.--
            (1) In general.--The Secretary shall document 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 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 required under such paragraph not 
                later than 180 days after such termination.
                    (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:
                            (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 constitute a 
                        clearly unwarranted invasion of personal 
                        privacy.

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:

``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).
    ``(b) Postclearance Requirements.--As part of the conditional 
clearance under subsection (a), the Secretary may impose the following:
            ``(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).
            ``(2) The Secretary--
                    ``(A) may require continuing evaluation and 
                periodic reporting on the safety, effectiveness, and 
                reliability of the device for its intended use; and
                    ``(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.
            ``(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.
            ``(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 effectiveness of the device, or to verify a 
                record, report, or information submitted to the agency.
            ``(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.
            ``(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 
                        device.
                            ``(ii) Labeling changes.
                            ``(iii) The use of a different facility or 
                        establishment to manufacture, process, or 
                        package the device.
                            ``(iv) Changes in sterilization procedures.
                            ``(v) Changes in packaging.
                            ``(vi) Changes in the performance or design 
                        specifications, circuits, components, 
                        ingredients, principle of operation, or 
                        physical layout of the device.
                            ``(vii) Extension of the expiration date of 
                        the device based on data obtained under a new 
                        or revised stability or sterility testing 
                        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 submitted:
                            ``(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.
                            ``(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.
                    ``(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 necessary 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 Federal Regulations.
    ``(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.''.
    (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''.
    (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''.
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