[Congressional Bills 114th Congress]
[From the U.S. Government Publishing Office]
[H.R. 2337 Introduced in House (IH)]
114th CONGRESS
1st Session
H. R. 2337
To amend the Federal Food, Drug, and Cosmetic Act to authorize priority
review for breakthrough devices.
_______________________________________________________________________
IN THE HOUSE OF REPRESENTATIVES
May 14, 2015
Mr. Pitts 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 to authorize priority
review for breakthrough devices.
Be it enacted by the Senate and House of Representatives of the
United States of America in Congress assembled,
SECTION 1. PRIORITY REVIEW FOR BREAKTHROUGH DEVICES.
(a) In General.--Chapter V of the Federal Food, Drug, and Cosmetic
Act is amended--
(1) in section 515(d)--
(A) by striking paragraph (5); and
(B) by redesignating paragraph (6) as paragraph
(5); and
(2) by inserting after section 515A (21 U.S.C. 360e-1) the
following:
``SEC. 515B. PRIORITY REVIEW FOR BREAKTHROUGH DEVICES.
``(a) In General.--In order to provide for more effective treatment
or diagnosis of life-threatening or irreversibly debilitating human
diseases or conditions, the Secretary shall establish a program to
provide priority review for devices--
``(1) representing breakthrough technologies;
``(2) for which no approved alternatives exist;
``(3) offering significant advantages over existing
approved or cleared alternatives, including the potential to,
compared to existing approved or cleared alternatives, reduce
or eliminate the need for hospitalization, improve patient
quality of life, facilitate patients' ability to manage their
own care (such as through self-directed personal assistance),
or establish long-term clinical efficiencies; or
``(4) the availability of which is in the best interest of
patients.
``(b) Request for Designation.--A sponsor of a device may request
that the Secretary designate the device for priority review under this
section. Any such request for designation may be made at any time prior
to the submission of an application under section 515(c), a petition
for classification under section 513(f)(2), or a notification under
section 510(k).
``(c) Designation Process.--
``(1) In general.--Not later than 60 calendar days after
the receipt of a request under subsection (b), the Secretary
shall determine whether the device that is the subject of the
request meets the criteria described in subsection (a). If the
Secretary determines that the device meets the criteria, the
Secretary shall designate the device for priority review.
``(2) Review.--Review of a request under subsection (b)
shall be undertaken by a team that is composed of experienced
staff and managers of the Food and Drug Administration and is
chaired by a senior manager.
``(3) Designation determination.--A determination approving
or denying a request under subsection (b) shall be considered a
significant decision under section 517A and the Secretary shall
provide a written, substantive summary of the basis for the
determination in accordance with section 517A(a).
``(4) Reconsideration.--
``(A) Request for reconsideration.--Any person
whose request under subsection (b) is denied may,
within 30 days of the denial, request reconsideration
of the denial in accordance with section 517A(b)--
``(i) based upon the submission of
documents by such person; or
``(ii) based upon such documents and a
meeting or teleconference.
``(B) Response.--Reconsideration of a designation
determination under this paragraph shall be conducted
in accordance with section 517A(b).
``(5) Withdrawal.--If the Secretary approves a priority
review designation for a device under this section, the
Secretary may not withdraw the designation based on the fact
that the criteria specified in subsection (a) are no longer met
because of the subsequent clearance or approval of another
device that was designated under--
``(A) this section; or
``(B) section 515(d)(5) (as in effect immediately
prior to the enactment of the 21st Century Cures Act).
``(d) Priority Review.--
``(1) Actions.--For purposes of expediting the development
and review of devices designated under subsection (c), the
Secretary shall--
``(A) assign a team of staff, including a team
leader with appropriate subject matter expertise and
experience, for each device for which a request is
submitted under subsection (b);
``(B) provide for oversight of the team by senior
agency personnel to facilitate the efficient
development of the device and the efficient review of
any submission described in subsection (b) for the
device;
``(C) adopt an efficient process for timely dispute
resolution;
``(D) provide for interactive communication with
the sponsor of the device during the review process;
``(E) expedite the Secretary's review of
manufacturing and quality systems compliance, as
applicable;
``(F) disclose to the sponsor in advance the topics
of any consultation concerning the sponsor's device
that the Secretary intends to undertake with external
experts or an advisory committee and provide the
sponsor an opportunity to recommend such external
experts;
``(G) for applications submitted under section
515(c), provide for advisory committee input, as the
Secretary determines appropriate (including in response
to the request of the sponsor); and
``(H) assign staff to be available within a
reasonable time to address questions by institutional
review committees concerning the conditions and
clinical testing requirements applicable to the
investigational use of the device pursuant to an
exemption under section 520(g).
``(2) Additional actions.--In addition to the actions
described in paragraph (1), for purposes of expediting the
development and review of devices designated under subsection
(c), the Secretary, in collaboration with the device sponsor,
may, as appropriate--
``(A) coordinate with the sponsor regarding early
agreement on a data development plan;
``(B) take steps to ensure that the design of
clinical trials is as efficient as practicable, such as
through adoption of shorter or smaller clinical trials,
application of surrogate endpoints, and use of adaptive
trial designs and Bayesian statistics, to the extent
scientifically appropriate;
``(C) facilitate, to the extent scientifically
appropriate, expedited and efficient development and
review of the device through utilization of timely
postmarket data collection, with regard to applications
for approval under section 515(c); and
``(D) agree to clinical protocols that the
Secretary will consider binding on the Secretary and
the sponsor, subject to--
``(i) changes agreed to by the sponsor and
the Secretary;
``(ii) changes that the Secretary
determines are required to prevent an
unreasonable risk to the public health; or
``(iii) the identification of a substantial
scientific issue determined by the Secretary to
be essential to the safety or effectiveness of
the device involved.
``(e) Priority Review Guidance.--
``(1) Content.--The Secretary shall issue guidance on the
implementation of this section. Such guidance shall include the
following:
``(A) The process for a person to seek a priority
review designation.
``(B) A template for requests under subsection (b).
``(C) The criteria the Secretary will use in
evaluating a request for priority review.
``(D) The standards the Secretary will use in
assigning a team of staff, including team leaders, to
review devices designated for priority review,
including any training required for such personnel on
effective and efficient review.
``(2) Process.--Prior to finalizing the guidance under
paragraph (1), the Secretary shall propose such guidance for
public comment.
``(f) Construction.--
``(1) Purpose.--This section is intended to encourage the
Secretary and provide the Secretary sufficient authorities to
apply efficient and flexible approaches to expedite the
development of, and prioritize the agency's review of, devices
that represent breakthrough technologies.
``(2) Construction.--Nothing in this section shall be
construed to alter the criteria and standards for evaluating an
application pursuant to section 515(c), a report and request
for classification under section 513(f)(2), or a report under
section 510(k), including the recognition of valid scientific
evidence as described in section 513(a)(3)(B), and
consideration of the least burdensome means of evaluating
device effectiveness or demonstrating substantial equivalence
between devices with differing technological characteristics,
as applicable. Nothing in this section alters the authority of
the Secretary to act on an application pursuant to section
515(d) before completion of an establishment inspection, as the
Secretary deems appropriate.''.
(b) Conforming Amendment Related to Designation Determinations.--
Section 517A(a)(1) of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 360g-1(a)(1)) is amended by inserting ``a request for
designation under section 515B,'' after ``an application under section
515,''.
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