[Federal Register Volume 81, Number 119 (Tuesday, June 21, 2016)]
[Pages 40315-40316]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-14562]



Food and Drug Administration

[Docket No. FDA-2016-N-1593]

Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; Medical Device 

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.


SUMMARY: The Food and Drug Administration (FDA) is announcing that a 
proposed collection of information has been submitted to the Office of 
Management and Budget (OMB) for review and clearance under the 
Paperwork Reduction Act of 1995 (the PRA).

DATES: Fax written comments on the collection of information by July 
21, 2016.

ADDRESSES: To ensure that comments on the information collection are 
received, OMB recommends that written comments be faxed to the Office 
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, 
FAX: 202-395-7285, or emailed to [email protected]. All 
comments should be identified with the OMB control number 0910-NEW and 
title ``Medical Device Accessories.'' Also include the FDA docket 
number found in brackets in the heading of this document.

Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver 
Spring, MD 20993-0002, [email protected].

SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has 
submitted the following proposed collection of information to OMB for 
review and clearance.

Medical Device Accessories--OMB Control Number 0910-NEW

    The draft guidance encourages manufacturers and other parties to 
utilize the process defined in section 513(f)(2) of the Federal Food, 
Drug, and Cosmetic Act (the FD&C Act) to request risk- and regulatory 
control-based classifications of new types of accessories. This process 
provides a pathway to class I or class II classification for accessory 
devices for which general controls, or general and special controls, 
provide a reasonable assurance of safety and effectiveness, but for 
which there is no legally marketed predicate device.
    In accordance with section 513(f)(2) of the FD&C Act, manufacturers 
and other parties may submit a de novo requesting FDA to make a 
classification determination for the accessory device according to the 
criteria in section 513(a)(1) of the FD&C Act. The de novo must include 
a description of the device and detailed information and reasons for 
any recommended classification (see section 513(f)(2)(A)(v) of the FD&C 
    In the Federal Register of January 20, 2015 (80 FR 2710), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. We received a total of 12 comments on the 
guidance. Of these the following were related to the information 
    Two comments raised concerns regarding the possible difficulties 
for manufacturers to submit a de novo for new accessories and for risk- 
and regulatory control-based classification of accessories that were 
approved under the premarket approval application (PMA) for the parent 
medical devices. One comment questioned whether FDA considered the 
possible ``practical and economic impact'' of the proposed definition 
of ``accessories'' that may result in manufacturers being obligated to 
list some components as accessories for FDA's registration and listing 
process. The second comment anticipates that ``few companies are likely 
to pursue this route given the associated costs and minimal advantage 
in time to market.'' Neither comment specifically discusses the 
potential PRA burden hours of voluntarily submitting a de novo 
application; however, it may be inferred that this could impact their 
resources under the PRA for submitting a de novo.
    Also, FDA is not proposing to limit or remove any mechanism that 
currently exists for manufacturers to obtain marketing authorization 
for accessories. De novos are typically less burdensome than PMAs for 
the purpose of classifying a new accessory. Furthermore, if a 
manufacturer wishes for an accessory to remain in the same regulatory 
class as the parent device, that manufacturer may continue to submit 
the accessory for clearance or

[[Page 40316]]

approval under the submission type applicable to the parent device.
    FDA estimates the burden of this collection of information as 

                                                     Table 1--Estimated Annual Reporting Burden \1\
                                                                                         Number of
                              Activity                                  Number of      responses per     Total annual    Average burden    Total hours
                                                                       respondents       respondent       responses       per response
Accessory classification de novo request...........................               8                1                8              180            1,440
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    Respondents are medical device manufacturers seeking to market 
device accessories. Of the approximately 41 de novo applications 
received per year, only 2 have been associated with accessories. With 
heightened awareness of the availability of the de novo pathway for 
accessories, we expect to receive four to six additional accessories 
applications per year. Therefore, we estimate that we will receive 
approximately eight accessory classification de novo requests per year. 
Based on estimates by FDA administrative and technical staff who are 
familiar with the proposed submission process for accessory 
classification requests and on our burden estimate for a similar 
information collection request (see ``De Novo Classification Process 
Evaluation of Automatic Class III Designation; Draft Guidance for 
Industry and Food and Drug Administration Staff; Availability,'' 79 FR 
47651 at 47653, August 14, 2014), we estimate that the submission 
process for each accessory classification request will take 
approximately 180 hours.
    The draft guidance also refers to previously approved collections 
of information found in FDA regulations. The collections of information 
in 21 CFR parts 801 and 809 have been approved under OMB control number 
0910-0485; the collections of information in 21 CFR part 807, subpart E 
have been approved under OMB control number 0910-0120; the collections 
of information in 21 CFR part 814 have been approved under OMB control 
number 0910-0231; and the collections of information in 21 CFR part 
860, subpart C, have been approved under OMB control number 0910-0138.

    Dated: June 15, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-14562 Filed 6-20-16; 8:45 am]