Instructions: In this task, you are given text for US Congressional and California state bills, your task is to generate a summary for this bill.
Input: 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''.
Output:
FDA Renewing Efficiency From Outside Reviewer Management Act of 2011 - Amends the Federal Food, Drug, and Cosmetic Act to revise and extend through October 1, 2017, provisions authorizing accredited persons to provide classification reports for a medical device and to inspect class II device or class III device facilities.

Deems a recommendation of an accredited person as to the classification of a medical device to be accepted by the Secretary of Health and Human Services (HHS) if the Secretary fails to make a determination with respect to the recommendation within 30 days.

Requires the Secretary to regularly publish: (1) detailed decision summaries for each clearance of a device, classification of a device, approval of an application of a device, or grant of exemption for a device occurring after the enactment of this Act; and (2) total product life cycles information for devices.

Expands the devices for which an accredited person may perform a review to include: (1) a class II device for which clinical data is required in the report, and (2) a class II device which is intended to be permanently implantable or life sustaining or supporting only if notification is provided to the Secretary before such a review. Deems the review permissible if the Secretary does not object within 60 days.

Requires the Secretary to provide for the initial training and periodic updating of training of accredited persons.

Makes accreditation valid for three years. Sets forth provisions regarding reaccreditation.

Prohibits an accredited person from being a sole practitioner. Provides that the prohibitions against an accredited person being owned or controlled by a manufacturer, supplier, or vendor of devices or engaging in the design, manufacture, promotion, or sale of devices shall apply only if the devices are of the same type for which the person is accredited.