112 
efficiently generate reliable and timely evidence about 
the effectiveness of the surveillance of devices with re-
spect to safety. 
SEC. 616. RISK-BASED CLASSIFICATION OF ACCESSORIES. 
(a) IN GENERAL.—Subsection (f) of section 513 of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360c) 
is amended by adding at the end the following new para-
graph: 
‘‘(6)(A) Subject to the succeeding subparagraphs of this 
paragraph, the Secretary shall, by written order, classify 
an accessory under this section based on the risks of the 
accessory when used as intended and the level of regulatory 
controls necessary to provide a reasonable assurance of safe-
ty and effectiveness of the accessory, notwithstanding the 
classification of any other device with which such accessory 
is intended to be used. 
‘‘(B) The classification of any accessory distinct from 
another device by regulation or written order issued prior 
to December 13, 2016, shall continue to apply unless and 
until the accessory is reclassified by the Secretary, notwith-
standing the classification of any other device with which 
such accessory is intended to be used. Nothing in this section 
shall preclude the Secretary’s ability to initiate the classi-
fication of an accessory through regulation or written order, 
as appropriate. 
VerDate Sep 11 2014 
21:19 Jul 11, 2017
Jkt 069200
PO 00000
Frm 00112
Fmt 6652
Sfmt 6203
E:\BILLS\H2430.RH
H2430
sradovich on DSK3GMQ082PROD with BILLS
113 
‘‘(C)(i) In the case of an accessory that has been grant-
ed marketing authorization as part of a submission under 
section 515(c), 510(k), or paragraph (2) of this subsection 
with another device with which such accessory is intended 
to be used, and with respect to which the Secretary has 
issued a written order classifying such accessory type dis-
tinct from another device in accordance with subparagraph 
(A), the manufacturer or importer of such accessory may, 
in lieu of submitting a request for classification of such ac-
cessory, submit a written request to the Secretary identi-
fying such classification. A request under this clause shall 
include such information to support the request as may be 
specified by the Secretary. 
‘‘(ii) A request under clause (i) shall include a rec-
ommendation for the proper classification of the accessory 
pursuant to subparagraph (A), and shall include such in-
formation as may be necessary for the Secretary to evaluate, 
based on the least burdensome approach, the appropriate 
class for the accessory under subsection (a). 
‘‘(iii) The Secretary shall respond to a request under 
clause (i) within 90 calendar days by granting or denying 
the request for reclassification of the accessory. 
‘‘(iv) Within 30 calendar days after granting a request 
submitted under clause (i), the Secretary shall publish a 
notice in the Federal Register announcing such response. 
VerDate Sep 11 2014 
21:19 Jul 11, 2017
Jkt 069200
PO 00000
Frm 00113
Fmt 6652
Sfmt 6203
E:\BILLS\H2430.RH
H2430
sradovich on DSK3GMQ082PROD with BILLS
114 
‘‘(v) A written notification that the Secretary disagrees 
with the classification recommended in a request pursuant 
to clause (ii) shall include a detailed description and jus-
tification for the determination to disagree. 
‘‘(D)(i) In the case of a device intended to be used with 
an accessory, where the accessory has been included in an 
application for premarket approval of such device under 
section 515 or a report under section 510(k) for clearance 
of such device and the Secretary has not classified such ac-
cessory distinctly from another device in accordance with 
subparagraph (A), the person filing the application or re-
port (as applicable) at the time such application or report 
is filed— 
‘‘(I) may include a written request for the proper 
classification of the accessory pursuant to subpara-
graph (A); 
‘‘(II) shall include in any such request such in-
formation as may be necessary for the Secretary to 
evaluate, based on the least burdensome approach, the 
appropriate class for the accessory under subsection 
(a); and 
‘‘(III) shall, if the request under subclause (I) is 
requesting classification of the accessory in class II, 
include in the application an initial draft proposal 
VerDate Sep 11 2014 
21:19 Jul 11, 2017
Jkt 069200
PO 00000
Frm 00114
Fmt 6652
Sfmt 6203
E:\BILLS\H2430.RH
H2430
sradovich on DSK3GMQ082PROD with BILLS
115 
for special controls, if special controls would be re-
quired pursuant to subsection (a)(1)(B). 
‘‘(ii) The Secretary’s response under section 515(d) or 
section 510(n) (as applicable) to an application or report 
described in clause (i) shall also contain the Secretary’s 
granting or denial of the request for classification of the 
accessory involved. 
‘‘(iii) The Secretary’s evaluation of an accessory under 
clause (i) shall constitute an order establishing a new classi-
fication for such accessory for the specified intended use or 
uses of such accessory and for any accessory with the same 
intended use or uses as such accessory. 
‘‘(E) For accessories that have been granted marketing 
authorization as part of a submission for another device 
with which the accessory involved is intended to be used, 
through an application for such other device under section 
515(c), a report under section 510(k), or a request for classi-
fication under paragraph (2) of this subsection, and that 
have not been classified by the Secretary based on the risks 
and appropriate level of regulatory controls in accordance 
with subparagraph (A): 
‘‘(i) Not later than the date that is one year after 
the date of enactment of the FDA Reauthorization Act 
of 2017 and at least once every 5 years thereafter, and 
as the Secretary otherwise deems appropriate, pursu-
VerDate Sep 11 2014 
21:19 Jul 11, 2017
Jkt 069200
PO 00000
Frm 00115
Fmt 6652
Sfmt 6203
E:\BILLS\H2430.RH
H2430
sradovich on DSK3GMQ082PROD with BILLS
116 
ant to this paragraph, the Secretary shall publish in 
the Federal Register a notice proposing a list of such 
accessories that the Secretary believes may be suitable 
for a distinct classification in class I and the pro-
posed regulations for such classifications. In devel-
oping such lists, the Secretary shall consider rec-
ommendations from sponsors of device submissions 
and other stakeholders for accessories to be included 
on such lists. The notices shall provide for a period 
of not less than 60 calendar days for public comment. 
Within 180 days after the end of the comment period, 
the Secretary shall publish in the Federal Register a 
final action classifying such suitable accessories into 
class I. 
‘‘(ii) A manufacturer or importer of an accessory 
that has been granted such marketing authorization 
may submit to the Secretary a written request for the 
appropriate classification of the accessory based on 
the risks and appropriate level of regulatory controls 
as described in subparagraph (A) or (C), and shall, 
if the request is requesting classification of the acces-
sory in class II, include in the submission an initial 
draft proposal for special controls, if special controls 
would be required pursuant to subsection (a)(1)(B). 
Such request shall include such information as may 
VerDate Sep 11 2014 
21:19 Jul 11, 2017
Jkt 069200
PO 00000
Frm 00116
Fmt 6652
Sfmt 6203
E:\BILLS\H2430.RH
H2430
sradovich on DSK3GMQ082PROD with BILLS
117 
be necessary for the Secretary to evaluate, based on 
the least burdensome approach, the appropriate class 
for the accessory under subsection (a). The Secretary 
shall provide an opportunity for a manufacturer or 
importer to meet with appropriate personnel of the 
Food and Drug Administration to discuss the appro-
priate classification of such accessory prior to submit-
ting a written request under this clause for classifica-
tion of the accessory. 
‘‘(iii) The Secretary shall respond to a request 
made under clause (ii) not later than 90 calendar 
days after receiving such submission by granting or 
denying the request for classification of the accessory, 
and the Secretary shall by written order classify such 
accessory or deny the request. If the Secretary does 
not agree with the recommendation for classification 
submitted by the manufacturer or importer, the re-
sponse shall include a detailed description and jus-
tification for such determination. Within 30 calendar 
days after granting such a request, the Secretary shall 
publish a notice in the Federal Register announcing 
such response. 
‘‘(F) Nothing in this paragraph may be construed as 
precluding a manufacturer of an accessory of a new type 
from using the classification process described in subsection 
VerDate Sep 11 2014 
21:19 Jul 11, 2017
Jkt 069200
PO 00000
Frm 00117
Fmt 6652
Sfmt 6203
E:\BILLS\H2430.RH
H2430
sradovich on DSK3GMQ082PROD with BILLS