To amend the Federal Food, Drug, and Cosmetic Act to provide predictability, consistency, and transparency to the premarket review process.

SECTION 1. SHORT TITLE.

    This Act may be cited as the ``Premarket Predictability Act of 
2011''.

SEC. 2. TRACKING AND REVIEW OF APPLICATIONS FOR INVESTIGATIONAL DEVICE 
              EXEMPTIONS.

    Section 520(g) of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 360j(g)) is amended by adding at the end the following:
    ``(8)(A) Upon the submission of an application for an exemption for 
a device under this subsection, the submission of a request to classify 
a device under section 513, or the submission of a report for a device 
under section 510(k), whichever occurs first, the Secretary shall 
assign a tracking number to the device.
    ``(B) The Secretary shall use such tracking number to record the 
following interactions between the Secretary and applicant with respect 
to the device:
            ``(i) Submission or approval of an application for an 
        exemption under this subsection.
            ``(ii) Submission or clearance of a report under section 
        510(k).
            ``(iii) Any meeting or meeting request, including in 
        anticipation of the submission of such an application or 
        report.
            ``(iv) Submission or approval of an application under 
        section 515(c).
            ``(v) Any formal or informal request by the Secretary for 
        additional information.
            ``(vi) Any deficiency letter.
            ``(vii) Any response by the applicant to a request 
        described in clause (v) or a deficiency letter.
            ``(viii) Any written submission by the applicant to the 
        Food and Drug Administration.
            ``(ix) Any other matter, as determined appropriate by the 
        Secretary.
    ``(9) Upon the submission of an application for an exemption under 
this subsection for a device, the Secretary shall assign, to review the 
application, a reviewer with prior review experience with that type of 
device or technology or other relevant expertise.''.

SEC. 3. OTHER RULES RELATING TO INVESTIGATIONAL DEVICE EXEMPTIONS.

    Section 520(g) of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 360j(g)) is amended--
            (1) in paragraph (2)(A), by adding at the end the 
        following: ``Procedures and conditions pursuant to the 
        preceding sentence shall require the Secretary, in determining 
        whether to grant such an exemption, to evaluate whether the 
        investigational study can be conducted ethically and with 
        reasonable risk.'';
            (2) in paragraph (2)(B)(ii), by striking ``evaluate the 
        safety and effectiveness of the device'' and inserting 
        ``evaluate whether the investigational study is being conducted 
        ethically and with reasonable risk'';
            (3) in paragraph (4)(B), by adding at the end the 
        following: ``The Secretary may not disapprove an application 
        because the investigation does not or may not meet any 
        requirement, including a data requirement, relating to the 
        approval or clearance of a device because the Secretary 
        believes that a different clinical testing design or plan could 
        produce data more relevant to an approval or clearance 
        decision.'';
            (4) in paragraph (7)(A), by striking ``(7)(A) In the case'' 
        and all that follows through the end paragraph (7)(A) and 
        inserting the following:
    ``(7)(A)(i) In the case of a person intending to investigate the 
safety or effectiveness of a class II or a class III device, the 
Secretary shall ensure that the person has an opportunity, prior to 
submitting an application to the Secretary, to submit to the Secretary, 
for review, an investigational plan (including a clinical protocol). If 
the applicant submits a written request for a meeting with the 
Secretary regarding such review, the Secretary shall, not later than 30 
days after receiving the request, meet with the applicant for the 
purpose of reaching agreement regarding the investigational plan 
(including a clinical protocol). The written request shall include a 
detailed description of the device, a detailed description of the 
proposed conditions of use of the device, information (if available) 
regarding the expected performance of the device, and a proposed plan 
(including a clinical protocol) for determining--
            ``(I) whether there is a reasonable assurance of safety and 
        effectiveness; or
            ``(II) whether the device is substantially equivalent to or 
        is at least as safe and effective as a legally marketed device 
        that is not subject to approval requirements under section 515.
    ``(ii) In the case where the Secretary fails to meet the applicant 
not later than 30 days after receiving a request as described under 
clause (i), the proposed plan submitted in such request shall be deemed 
to be the agreement reached between the Secretary and the applicant 
under subparagraph (B) and such agreement shall not be subject to 
change except as provided in subparagraph (B).''; and
            (5) in paragraph (7)(B)(ii), by inserting ``that has 
        emerged since the date of the agreement and that is'' after 
        ``substantial scientific issue''.

SEC. 4. CLARIFICATION OF LEAST BURDENSOME STANDARD.

    (a) Premarket Approval.--Section 513(a)(3)(D) of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 360c(a)(3)(D)) is amended--
            (1) by redesignating clause (iii) as clause (iv); and
            (2) by inserting after clause (ii) the following:
    ``(iii) In carrying out clause (ii), the Secretary--
            ``(I) shall not request information unrelated or irrelevant 
        to a demonstration of reasonable assurance of device 
        effectiveness;
            ``(II) shall consider alternative approaches to evaluating 
        device effectiveness in order to reduce the time, effort, and 
        cost of reaching proper resolution of the issue;
            ``(III) shall use all reasonable mechanisms to lessen 
        review times and render regulatory decisions;
            ``(IV) shall consider whether pre-clinical data, such as 
        well-designed bench and animal testing, can meet the statutory 
        threshold for approval; and
            ``(V) if clinical data are needed, shall consider 
        alternatives to randomized, controlled clinical trials and the 
        use of surrogate endpoints.''.
    (b) Substantial Equivalence Determination.--Section 513(i)(1)(D) of 
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360c(i)(1)(D)) is 
amended--
            (1) by striking ``(D) Whenever'' and inserting ``(D)(i) 
        Whenever''; and
            (2) by adding at the end the following:
    ``(ii) In carrying out clause (i), the Secretary--
            ``(I) shall focus on whether there is a reasonable 
        assurance that the device is safe and effective for its 
        intended use;
            ``(II) shall not request or accept information unrelated or 
        irrelevant to the substantial equivalence evaluation;
            ``(III) shall review the labeling of the device to assess 
        the intended use of the device, and shall not evaluate issues 
        that do not present a major impact on the intended use as set 
        forth in the labeling;
            ``(IV) shall consider alternative approaches to evaluating 
        substantial equivalence in order to reduce the time, effort, 
        and cost of reaching proper resolution of the issue; and
            ``(V) shall use all reasonable mechanisms to lessen review 
        times and render regulatory decisions.''.

SEC. 5. AGENCY DOCUMENTATION AND REVIEW OF SIGNIFICANT DECISIONS.

    Chapter V of the Federal Food, Drug, and Cosmetic Act is amended by 
inserting after section 517 (21 U.S.C. 360g) the following:

``SEC. 517A. AGENCY DOCUMENTATION AND REVIEW OF SIGNIFICANT DECISIONS 
              REGARDING DEVICES.

    ``(a) Documentation of Rationale for Significant Decisions.--
            ``(1) In general.--The Secretary shall completely document 
        the scientific and regulatory rationale for any significant 
        decision of the Center for Devices and Radiological Health 
        regarding submission or review of a report under section 
        510(k), an application under section 515, or an application for 
        an exemption under section 520(g), including documentation of 
        significant controversies or differences of opinion and their 
        resolution.
            ``(2) Provision of documentation.--Upon request, the 
        Secretary shall furnish such complete documentation to the 
        person who is seeking to submit, or who has submitted, such 
        report or application.
    ``(b) Appeal Rights and Procedures.--
            ``(1) Appeal to center director.--Any person may, within 30 
        days after a significant decision described in subsection 
        (a)(1), appeal such decision to the Director of the Center for 
        Devices and Radiological Health (in this subsection referred to 
        as the `Center Director').
            ``(2) Petition; procedures.--The Center Director--
                    ``(A) may require that an appeal under paragraph 
                (1) be in writing and set forth the decision being 
                appealed and the grounds for the appeal; and
                    ``(B) subject to paragraph (6), may provide for 
                such procedures as may be necessary with respect to 
                such an appeal.
            ``(3) Resolution by center director.--
                    ``(A) Meeting.--The Center Director shall provide, 
                upon the request of any person bringing an appeal under 
                paragraph (1), for at least one meeting, to be held 
                within 45 days after the filing of the appeal, to 
                discuss the significant decision involved, the appeal 
                of such decision, and possible resolutions of the 
                appeal.
                    ``(B) Final decision.--The Center Director shall 
                issue a final written decision resolving any appeal 
                under paragraph (1), including the grounds for such 
                decision, not later than 90 days after the filing of 
                the appeal.
            ``(4) Appeal to commissioner.--
                    ``(A) In general.--Any person who files an appeal 
                under paragraph (1)--
                            ``(i) within 30 days after receiving any 
                        decision of the Center Director resolving the 
                        appeal, may appeal such decision to the 
                        Commissioner; or
                            ``(ii) if the Center Director has not made 
                        a decision resolving the appeal under paragraph 
                        (1) within 90 days after the filing of such 
                        appeal, may file directly with the Commissioner 
                        an appeal of the significant decision subject 
                        to such appeal under paragraph (1).
                    ``(B) Final decision.--The Commissioner shall issue 
                a final written decision resolving any appeal under 
                subparagraph (A), including the grounds for such 
                decision, not later than 30 days after the filing of 
                such appeal under subparagraph (A).
            ``(5) Report.--The Commissioner shall issue a public report 
        on at least an annual basis that sets forth--
                    ``(A) the number of appeals under paragraph (1) and 
                the disposition of those appeals;
                    ``(B) for each appeal under paragraph (1), the 
                number of days taken to reach a final decision under 
                paragraph (3)(B);
                    ``(C) the number of appeals to the Commissioner 
                under paragraph (4)(A), including the number of such 
                appeals under paragraph (4)(A)(ii), and the disposition 
                of those appeals; and
                    ``(D) the number of appeals for which the 
                Commissioner does not issue a final decision within 30 
                days as required by paragraph (4)(B).
            ``(6) Authority of secretary to establish appeal procedures 
        and timelines.--
                    ``(A) Establishment.--Subject to subparagraph (B), 
                the Secretary may, by regulation or guidance, establish 
                appeal procedures or timelines applicable to appeals 
                under paragraph (1) or (4).
                    ``(B) Limitation.--No procedure or timeline 
                established under subparagraph (A) may alter any 
                requirement or extend or delay any timeline specified 
                in any of paragraphs (1) through (5).''.

SEC. 6. TRANSPARENCY IN CLEARANCE PROCESS.

    (a) Publication of Detailed Decision Summaries.--Section 520(h) of 
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360j(h)) is amended 
by adding at the end the following:
    ``(5) Subject to subsection (c) and section 301(j), the Secretary 
shall regularly publish detailed decision summaries for each clearance 
of a device under section 510(k).''.
    (b) Application.--The requirement of section 520(h)(5) of the 
Federal Food, Drug, and Cosmetic Act, as added by subsection (a), 
applies only with respect to clearance of a device occurring after the 
date of the enactment of this Act.

Summary: Premarket Predictability Act of 2011 - Amends the Federal Food, Drug, and Cosmetic Act to require the Secretary of Health and Human Services (HHS) to assign a tracking number to a medical device upon submission of: (1) an application for an exemption of a device for investigational use, (2) a request to classify a device, or (3) a premarket report or notification related to a device. Requires the Secretary to use the tracking number to record interactions between the Secretary and applicant with respect to the device.

Directs the Secretary to: (1) assign a reviewer with prior review experience with the type of of device or technology involved or other relevant expertise to review an application for an exemption of a device for investigational use, and (2) evaluate whether the investigational study can be conducted ethically with reasonable risk in determining whether to grant an exemption for investigational use.

Prohibits the Secretary from disapproving an application because the investigation does not or may not meet any requirement relating to the approval or clearance of a device because the Secretary believes that a different clinical testing design or plan could produce data more relevant to an approval or clearance decision.

Revises the procedures relating to submission of an application to investigate a class II or a class III device, which may include a plan for determining whether the device is substantially equivalent to or is at least as safe and effective as a legally marketed device that is not subject to premarket approval requirements.

Sets forth requirements for the Secretary to meet in determining the least burdensome appropriate means of evaluating medical device effectiveness that would have a reasonable likelihood of resulting in approval.

Requires the Secretary to document the scientific and regulatory rationale for any significant decision of the Center for Devices and Radiological Health regarding device review, approval, or exemption. Sets forth appeal procedures. Requires the Secretary to regularly publish detailed decision summaries for each clearance of a device not requiring premarket approval.