This bill amends the Federal Food, Drug, and Cosmetic Act to require the Food and Drug Administration (FDA) to establish a third-party quality system assessment program to accredit persons to assess whether a medical device manufacturer's quality system can ensure the safety and effectiveness of an approved medical device after certain changes, including changes in manufacturing or changes to enhance device safety.
Device manufacturers are allowed to make changes to a device without submitting to the FDA the 30-day notice required for manufacturing changes or a premarket approval supplement if their quality system has been certified by an accredited person.
An accredited person who assesses a device manufacturer's quality system must submit a summary of their assessment and, as appropriate, a certification to the FDA within 30 days of the assessment. An assessment summary and certification is deemed accepted by the FDA 30 days after submission unless the FDA determines that additional information is needed to support certification, the assessment or certification is unwarranted, or an action other than acceptance of the certification is otherwise justified.
Periodic reports by device manufacturers must describe any changes made to a device without submission of the 30-day notice or the premarket approval supplement.
Certifications accepted by the FDA remain in effect for two years.
The FDA must report on this quality system assessment program no later than January 31, 2022. The program is terminated at the end of FY2022.
[Congressional Bills 114th Congress]
[From the U.S. Government Publishing Office]
[H.R. 2422 Introduced in House (IH)]
114th CONGRESS
1st Session
H. R. 2422
To amend the Federal Food, Drug, and Cosmetic Act with respect to
third-party quality system assessment.
_______________________________________________________________________
IN THE HOUSE OF REPRESENTATIVES
May 19, 2015
Mr. Shimkus 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
third-party quality system assessment.
Be it enacted by the Senate and House of Representatives of the
United States of America in Congress assembled,
SECTION 1. THIRD-PARTY QUALITY SYSTEM ASSESSMENT.
(a) Establishment of Third-Party Quality System Assessment
Program.--Chapter V of the Federal Food, Drug, and Cosmetic Act is
amended by inserting after section 524A (21 U.S.C. 360n-1) the
following new section:
``SEC. 524B. THIRD-PARTY QUALITY SYSTEM ASSESSMENT.
``(a) Accreditation and Assessment.--
``(1) In general; certification of device quality system.--
The Secretary shall, in accordance with this section, establish
a third-party quality system assessment program--
``(A) to accredit persons to assess whether a
requestor's quality system, including its design
controls, can reasonably assure the safety and
effectiveness of in-scope devices subject to device-
related changes (as defined in paragraph (2));
``(B) under which accredited persons shall, as
applicable, certify that a requestor's quality system
meets the criteria issued under paragraph (5) with
respect to the in-scope devices at issue; and
``(C) under which the Secretary shall rely on such
certifications for purposes of determining the safety
and effectiveness of in-scope devices subject to the
device-related changes involved, in lieu of compliance
with the following submission requirements:
``(i) A thirty-day notice (as defined in
paragraph (2)).
``(ii) A Special PMA supplement (as defined
in paragraph (2)).
``(2) Definitions.--For purposes of this sectionU
``(A) the term `device-related changes' means
changes made by a requestor with respect to in-scope
devices, which are--
``(i) manufacturing changes subject to a
30-day notice;
``(ii) changes that qualify for a Special
PMA supplement; and
``(iii) such other changes relating to the
devices or the device manufacturing process as
the Secretary determines appropriate;
``(B) the term `in-scope device' means a device
within the scope of devices agreed to by the requestor
and the accredited person for purposes of a request for
certification under this section;
``(C) the term `quality system' means a quality
system described in section 520(f);
``(D) the term `requestor' means a device
manufacturer that is seeking certification under this
section of a quality system used by such manufacturer;
``(E) the term `Special PMA' means a Special PMA
supplement under section 814.39(d) of title 21, Code of
Federal Regulations (or any successor regulations); and
``(F) the term `thirty-day notice' means a notice
described in section 515(d)(6).
``(3) Accreditation process; accreditation renewal.--Except
as inconsistent with this section, the process and
qualifications for accreditation of persons and renewal of such
accreditation under section 704(g) shall apply with respect to
accreditation of persons and renewal of such accreditation
under this section.
``(4) Use of accredited parties to conduct assessments.--
``(A) Initiation of assessment services.--
``(i) Date assessments authorized.--
Beginning after issuance of the final guidance
under paragraph (5), an accredited person may
conduct an assessment under this section.
``(ii) Initiation of assessments.--Use of
one or more accredited persons to assess a
requestor's quality system under this section
with respect to in-scope devices shall be at
the initiation of the person who registers and
lists the devices at issue under section 510.
``(B) Compensation.--Compensation for such
accredited persons shall--
``(i) be determined by agreement between
the accredited person and the person who
engages the services of the accredited person;
and
``(ii) be paid by the person who engages
such services.
``(C) Accredited person selection.--Each person who
chooses to use an accredited person to assess a
requestor's quality system, as described in this
section, shall select the accredited person from a list
of such persons published by the Secretary in
accordance with section 704(g)(4).
``(5) Guidance; criteria for certification.--
``(A) In general.--The criteria for certification
of a quality system under this section shall be as
specified by the Secretary in guidance issued under
this paragraph.
``(B) Contents; certification criteria.--The
guidance under this paragraph shall include
specification of--
``(i) evaluative criteria to be used by an
accredited person to assess and as applicable
certify a requestor's quality system under this
section with respect to in-scope devices ; and
``(ii) criteria for accredited persons to
apply a waiver of and exemptions from the
certification criteria under clause (i).
``(C) Timeframe for issuing guidance.--The
Secretary shall issue under this paragraph--
``(i) draft guidance not later than 12
months after the enactment of the 21st Century
Cures Act; and
``(ii) final guidance not later than 12
months after issuance of the draft guidance
under clause (i).
``(b) Use of Third-Party Assessment.--
``(1) Assessment summary; certification.--
``(A) Submission of assessment to secretary.--An
accredited person who assesses a requestor's quality
system under subsection (a) shall submit to the
Secretary a summary of the assessment--
``(i) within 30 days of the assessment; and
``(ii) which as applicable shall include--
``(I) the accredited person's
certification that the requestor has
satisfied the criteria issued under
subsection (a)(5) for quality system
certification with respect to the in-
scope devices at issue; and
``(II) any waivers or exemptions
from such criteria applied by the
accredited person.
``(B) Treatment of assessments.--Subject to action
by the Secretary under subparagraph (C), with respect
to assessments which include a certification under this
section--
``(i) the Secretary's review of the
assessment summary shall be deemed complete on
the day that is 30 days after the date on which
the Secretary receives the summary under
subparagraph (A); and
``(ii) the assessment summary and
certification of the requestor shall be deemed
accepted by the Secretary on such 30th day.
``(C) Actions by secretary.--
``(i) In general.--Within 30 days of
receiving an assessment summary and
certification under subparagraph (A), the
Secretary may, by written notice to the
accredited person submitting such assessment
certification, deem any such certification to
be provisional beyond such 30-day period,
suspended pending further review by the
Secretary, or otherwise qualified or cancelled,
based on the Secretary's determination that (as
applicable)--
``(I) additional information is
needed to support such certification;
``(II) such assessment or
certification is unwarranted; or
``(III) such action with regard to
the certification is otherwise
justified according to such factors and
criteria as the Secretary finds
appropriate.
``(ii) Acceptance of certification.--If
following action by the Secretary under clause
(i) with respect to a certification, the
Secretary determines that such certification is
acceptable, the Secretary shall issue written
notice to the applicable accredited person
indicating such acceptance.
``(2) Notifications to secretary by certified manufacturers
for program evaluation purposes.--
``(A) Periodic notification for manufacturing
changes otherwise subject to thirty-day notice.--A
requestor certified under this section that effectuates
device-related changes with respect to in-scope
devices, without prior submission of a thirty-day
notice, shall provide notification to the Secretary of
such changes in the requestor's next periodic report
under section 814.84(b) of title 21, Code of Federal
Regulations (or any successor regulation). Such
notification shall--
``(i) describe the changes made; and
``(ii) indicate the effective dates of such
changes.
``(B) Periodic notification for device-related
changes otherwise subject to special pma supplement.--A
requestor certified under this section that effectuates
device-related changes with respect to in-scope
devices, without prior submission of a Special PMA
Supplement, shall provide notification to the Secretary
of such changes in the requestor's next periodic report
under section 814.84(b) of title 21, Code of Federal
Regulations (or any successor regulation). Such
notification shall--
``(i) describe the changes made, including
a full explanation of the basis for the
changes; and
``(ii) indicate the effective dates of such
changes.
``(C) Use of notifications for program evaluation
purposes.--Information submitted to the Secretary under
subparagraphs (A) and (B) shall be used by the
Secretary for purposes of the program evaluation under
subsection (d).
``(c) Duration and Effect of Certification.--A certification under
this section--
``(1) shall remain in effect for a period of two years from
the date such certification is accepted by the Secretary,
subject to paragraph (6);
``(2) may be renewed through the process described in
subsection (a)(3);
``(3) shall continue to apply with respect to device-
related changes made during such 2-year period, provided the
certification remains in effect, irrespective of whether such
certification is renewed after such 2-year period;
``(4) shall have no effect on the need to comply with
applicable submission requirements specified in subsection
(a)(1)(C) with respect to any change pertaining to in-scope
devices which is not a device-related change under subsection
(a)(2);
``(5) shall have no effect on the authority of the
Secretary to conduct an inspection or otherwise determine the
requestor's conformance with the applicable requirements of
this Act; and
``(6) shall be considered to be revoked if the Secretary
provides written notification to the certified requestor that
its quality system does not satisfy the certification criteria
issued under subsection (a)(5) with respect to the in-scope
devices at issue, such that the applicable submission
requirements specified in subsection (a)(1)(C) must be met for
changes made after receipt of such written notification, with
respect to such devices.
``(d) Program Evaluation; Sunset.--
``(1) Program evaluation and report.--
``(A) Evaluation.--The Secretary shall complete an
evaluation of the third-party quality system assessment
program under this section no later than January 31,
2021, based on--
``(i) analysis of information from a
representative group of device manufacturers
obtained from notifications provided by
certified requestors under subsection (b)(2);
and
``(ii) such other available information and
data as the Secretary determines appropriate.
``(B) Report.--No later than 1 year after
completing the evaluation under subparagraph (A), the
Secretary shall issue a report of the evaluation's
findings on the website of the Food and Drug
Administration, which shall include the Secretary's
recommendations with respect to continuation and as
applicable expansion of the program under this section
to include additional types of submissions and
additional types of changes beyond those identified in
subsection (a)(1)(C), including changes to devices
cleared under section 510(k). At the discretion of the
Secretary, the program may be expanded prior to January
31, 2021.
``(2) Sunset.--This section shall cease to be effective
October 1, 2022.
``(e) Rule of Construction.--Nothing in this section shall be
construed to limit the authority of the Secretary to request and review
the complete assessment of a certified requestor under this section on
a for-cause basis.''.
(b) Conforming Amendments.--
(1) Requirements for premarket approval supplements.--
Section 515(d)(6)(A)(i) of the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 360e(d)(6)(A)(i)) is amended by inserting ``,
subject to section 524B,'' after ``that affects safety or
effectiveness''.
(2) Requirements for thirty-day notice.--Section
515(d)(6)(A)(ii) of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 360e(d)(6)(A)(ii)) is amended by inserting ``,
subject to section 524B,'' after ``the date on which the
Secretary receives the notice''.
<all>
Introduced in House
Introduced in House
Referred to the House Committee on Energy and Commerce.
Referred to the Subcommittee on Health.
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