1.Short title; table of
contents
(a)This Act may be cited
as the Safe, Efficient, and
Transparent Medical Device Approval Act
or the
SET Device
Act
.
(b)The table of contents for this Act is as follows:
Sec. 1. Short title; table of contents.
Sec. 2. Findings.
Sec. 3. Establishment of schedule and promulgation of
regulation.
Sec. 4. Modification of de novo application
process.
2.Congress finds as follows:
(1)Under the Safe Medical Devices Act of 1990
(Public Law 101–629), Congress amended section 515 of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 360e) to require the Food and Drug Administration
to reclassify preamendment class III devices to a lower class or to require
them to go through the premarket approval process.
(2)The Food and Drug
Administration has not yet complied with the mandate of Congress under such
Act.
(3)The de novo
process, created by the Food and Drug Administration Modernization Act of 1997
(Public Law 105–115), is an approval mechanism by which the Food and Drug
Administration may down-classify, to class I or class II, devices that have no
predicates and thus are designated class III, but are deemed to be of low to
moderate risk. The process avoids having novel, low- to moderate-risk devices
go through the premarket approval process. Under the current de novo process,
the manufacturer must first make a submission under section 510(k) of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360), even if no known
predicate device exists. A 2011 Institute of Medicine report found that,
between 2005 and 2009, review times for novel therapeutic devices through the
de novo process nearly tripled. The report concluded that the current de novo
process has not met its potential as an alternative regulatory pathway, and
recommended the establishment of a modified de novo process.
3.Establishment of
schedule and promulgation of regulation
(a)Establishment of
scheduleNot later than 120
days after the date of enactment of this Act, the Secretary of Health and Human
Services (referred to in this section as the Secretary
), shall
establish the schedule referred to in section 515(i)(3) of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 360e(i)(3)) for each device that the
Secretary requires to remain in class III through a determination under section
515(i)(2) of such Act.
(b)Action regarding
class II and IIINot later
than 18 months after the date of enactment of this Act, the Secretary
shall—
(1)issue a final regulation under section
515(b) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360e(b)) for each
device that the Secretary requires to remain in class III through a
determination under section 515(i)(2) of such Act; and
(2)establish the
special controls required by section 513(a)(1)(B) of such Act (21 U.S.C.
360c(a)(1)(B)) for each device that is classified into class II pursuant to a
determination revising the classification of the device under section 515(i)(2)
of such Act.
4.Modification of de
novo application process
(a)Section 513(f)(2) of
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360c(f)(2)) is
amended—
(1)by redesignating subparagraphs (B) and (C)
as subparagraphs (C) and (D), respectively;
(2)by amending subparagraph (A) to read as
follows:
(A)In the case of a type of device that
has not previously been classified under this Act, a person may do one of the
following:
(i)Submit a report under section 510(k),
and, if the device is classified into class III under paragraph (1), such
person may request, not later than 30 days after receiving written notice of
such a classification, the Secretary to classify the device under the criteria
set forth in subparagraphs (A) through (C) of subsection (a)(1). The person
may, in the request, recommend to the Secretary a classification for the
device. Any such request shall describe the device and provide detailed
information and reasons for the recommended classification.
(ii)Submit a request for initial
classification of the device under this subparagraph, if the person declares
that there is no legally marketed device upon which to base a substantial
equivalence determination as that term is defined in section 513(i). Subject to
subparagraph (B), the Secretary shall classify the device under the criteria
set forth in subparagraphs (A) through (C) of subsection (a)(1). The person
submitting the request for classification under this subparagraph may recommend
to the Secretary a classification for the device and shall include in the
request an initial draft proposal for applicable special controls, as described
in subsection (a)(1)(B), that are necessary, in conjunction with general
controls, to provide reasonable assurance of safety and effectiveness and a
description of how the special controls provide such
assurance.
;
(3)by inserting
after subparagraph (A) the following:
(B)The Secretary may decline to
undertake a classification request submitted under clause (2)(A)(ii) if the
Secretary identifies a legally marketed device that could provide a reasonable
basis for review of substantial equivalence under paragraph (1), or when the
Secretary determines that the device submitted is not of low-moderate
risk.
;
and
(4)in subparagraph
(C), as so redesignated—
(A)in clause (i), by
striking Not later than 60 days after the date of the submission of the
request under subparagraph (A),
and inserting Not later than 90
days after the date of the submission of the request under subparagraph (A)(i)
or 120 days after the date of the submission of the request under subparagraph
(A)(ii),
; and
(B)in clause (ii),
by inserting or is classified in
after remains
in
.
(b)Not later than 2 years after the date of enactment of this
Act, the Comptroller General of the United States shall complete a study and
submit to Congress a report on the effectiveness of the review pathway under
section 513(f)(2)(A) of the Federal Food, Drug, and Cosmetic Act, as amended by
this Act.
(c)Section 513(f)(1)(B) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 360c(f)(1)(B)) is amended by inserting a request
under paragraph (2) or
after response to
.