[Congressional Bills 112th Congress]
[From the U.S. Government Publishing Office]
[H.R. 3205 Introduced in House (IH)]

112th CONGRESS
  1st Session
                                H. R. 3205

   To amend the Federal Food, Drug, and Cosmetic Act with respect to 
persons who, with respect to devices, are accredited to perform certain 
                        reviews or inspections.


_______________________________________________________________________


                    IN THE HOUSE OF REPRESENTATIVES

                            October 14, 2011

 Mr. Paulsen (for himself, Mr. Altmire, Mr. Kinzinger of Illinois, Mr. 
    Guthrie, Mr. Cassidy, Mr. Shimkus, Mrs. McMorris Rodgers, Mrs. 
Blackburn, Mr. Latta, Mr. Kline, Mrs. Bachmann, Mr. Cravaack, Mrs. Bono 
    Mack, and Mr. Bilbray) 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 with respect to 
persons who, with respect to devices, are accredited to perform certain 
                        reviews or inspections.

    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 ``FDA Renewing Efficiency From Outside 
Reviewer Management Act of 2011''.

SEC. 2. PERSONS ACCREDITED TO REVIEW REPORTS UNDER 510(K) AND MAKE 
              RECOMMENDATIONS FOR INITIAL CLASSIFICATION.

    (a) Time Period for Review of Recommendations of Accredited 
Persons.--Section 523(a) of the Federal Food, Drug, and Cosmetic Act 
(21 U.S.C. 360m(a)) is amended--
            (1) in paragraph (1), by striking ``reviewing reports'' and 
        inserting ``reviewing and making recommendations to the 
        Secretary regarding reports''; and
            (2) in paragraph (2), by amending subparagraph (B) to read 
        as follows:
                    ``(B) Time period for review.--Not later than 30 
                days after the date on which the Secretary is notified 
                under subparagraph (A) by an accredited person with 
                respect to a recommendation regarding a report 
                submitted under section 510(k) or an initial 
                classification of a device, the Secretary shall make a 
                determination with respect to the recommendation. If 
                the Secretary fails to make such a determination by the 
                end of such 30-day period, the recommendation is deemed 
                to be accepted by the Secretary.''.
    (b) Access to Device Information.--Paragraph (2) of section 523(a) 
of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360m(a)) is 
amended by adding at the end the following:
                    ``(D) Access to device information.--Subject to 
                section 301(j), for the purpose of providing accredited 
                persons with additional information to review reports 
                submitted under section 510(k) and make recommendations 
                regarding the initial classification of devices, the 
                Secretary shall regularly publish--
                            ``(i) detailed decision summaries for each 
                        clearance of a device under section 510(k), 
                        classification of a device under section 513, 
                        approval of an application for a device under 
                        section 515, or grant of an exemption for a 
                        device under section 520(m), occurring after 
                        the date of the enactment of this subparagraph; 
                        and
                            ``(ii) total product life cycles 
                        information for devices.''.
    (c) Types of Devices To Be Reviewed.--Paragraph (3) of section 
523(a) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360m(a)) 
is amended to read as follows:
            ``(3) Certain devices.--
                    ``(A) In general.--An accredited person may be used 
                to perform a review regarding any report submitted 
                under section 510(k) except that an accredited person--
                            ``(i) may not be used to perform a review 
                        of a class III device; and
                            ``(ii) may be used to perform a review of a 
                        class II device which is intended to be 
                        permanently implantable or life sustaining or 
                        supporting only if a notification is submitted 
                        under subparagraph (B).
                    ``(B) Notification of intent to perform a review.--
                Before performing a review of a report submitted under 
                section 510(k) for a class II device which is intended 
                to be permanently implantable or life sustaining or 
                supporting, an accredited person shall submit to the 
                Secretary a notification of the person's intent to 
                perform the review. If the Secretary does not object 
                within 60 days after receipt of such a notification, 
                the Secretary is deemed to allow the accredited person 
                to perform such review. If the Secretary objects to 
                performance of the review by the accredited person, the 
                Secretary shall specify in writing the basis for the 
                objection, including any reasons why the accredited 
                person is not capable of performing the review in a 
                manner which provides a reasonable assurance of the 
                safety and effectiveness of the device for its intended 
                purpose.''.
    (d) Accreditation.--Section 523(b) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 360m(b)) is amended--
            (1) in paragraph (2)--
                    (A) in the heading of subparagraph (C), by 
                inserting ``and training'' after ``auditing'';
                    (B) in subparagraph (C)--
                            (i) in clause (i), by striking ``and'' at 
                        the end;
                            (ii) by redesignating clause (ii) as clause 
                        (iii); and
                            (iii) by inserting after clause (i) the 
                        following:
                            ``(ii) provide for the initial training and 
                        periodic updating of training of such person; 
                        and''; and
                    (C) by adding at the end the following:
                    ``(E) Periodic reaccreditation.--
                            ``(i) Period.--Subject to suspension or 
                        withdrawal under subparagraph (B), any 
                        accreditation under this section shall be valid 
                        for a period of 3 years after its issuance.
                            ``(ii) Response to reaccreditation 
                        request.--Upon the submission of a request by 
                        an accredited person to be reaccredited under 
                        this section, the Secretary shall approve or 
                        deny such request not later than 60 days after 
                        receipt of the request.
                            ``(iii) Criteria.--Not later than 120 days 
                        after the date of the enactment of this 
                        subparagraph, the Secretary shall establish and 
                        publish in the Federal Register criteria to 
                        reaccredit or deny reaccreditation to persons 
                        under this section. The reaccreditation of 
                        persons under this section shall specify the 
                        particular activities under subsection (a) for 
                        which such persons are accredited.'';
            (2) in paragraph (3)--
                    (A) in subparagraph (A), by inserting ``a sole 
                practitioner or'' after ``may not be'';
                    (B) in subparagraph (B), by striking ``such a 
                manufacturer, supplier, or vendor'' and inserting ``a 
                manufacturer, supplier, or vendor of devices of the 
                type for which such person is accredited''; and
                    (C) in subparagraph (D), by striking ``devices'' 
                and inserting ``devices of the type for which such 
                person is accredited'';
            (3) by striking paragraph (4) (relating to selection of 
        accredited persons); and
            (4) by redesignating paragraph (5) as paragraph (4).
    (e) Duration of Authority.--Section 523(c) of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 360m(c)) is amended by striking 
``October 1, 2012'' and inserting ``October 1, 2017''.
    (f) Report.--Section 523(d) of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 360m(d)) is amended by striking ``January 10, 2007'' and 
inserting ``January 15, 2015''.

SEC. 3. PERSONS ACCREDITED TO CONDUCT INSPECTIONS.

    Section 704(g)(11) of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 374(g)(11)) is amended by striking ``October 1, 2012'' and 
inserting ``October 1, 2017''.
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