[Federal Register Volume 84, Number 209 (Tuesday, October 29, 2019)]
[Notices]
[Pages 57877-57878]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-23585]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2019-D-4258]


Type V Drug Master Files for Center for Drug Evaluation and 
Research-Led Combination Products Using Device Constituent Parts With 
Electronics or Software; Draft Guidance for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing 
the availability of a draft guidance for industry entitled ``Type V 
DMFs for CDER-Led Combination Products Using Device Constituent Parts 
With Electronics or Software.'' A drug master file (DMF) is a voluntary 
submission to FDA that may be used to provide confidential detailed 
information about facilities, processes, or articles used in the 
manufacturing, processing, packaging, and storing of one or more human 
drugs. This draft guidance explains when a Type V DMF may be used to 
submit information regarding a combination product for which the Center 
for Drug Evaluation and Research (CDER) has primary jurisdiction (i.e., 
a CDER-led combination product) and which features a device constituent 
part with electronics and/or software that is planned to be used as a 
platform, that is, may be used in multiple CDER-led combination 
products. The draft guidance also describes the administrative process 
and outlines the recommended content for these Type V DMF submissions 
and amendments.

DATES: Submit either electronic or written comments on the draft 
guidance by December 30, 2019 to ensure that the Agency considers your 
comment on this draft guidance before it begins work on the final 
version of the guidance.

ADDRESSES: You may submit comments on any guidance at any time as 
follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to https://www.regulations.gov 
will be posted to the docket unchanged. Because your comment will be 
made public, you are solely responsible for ensuring that your comment 
does not include any confidential information that you or a third party 
may not wish to be posted, such as medical information, your or anyone 
else's Social Security number, or confidential business information, 
such as a manufacturing process. Please note that if you include your 
name, contact information, or other information that identifies you in 
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential 
information that you do not wish to be made available to the public, 
submit the comment as a written/paper submission and in the manner 
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper 
submissions): Dockets Management Staff (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets 
Management Staff, FDA will post your comment, as well as any 
attachments, except for information submitted, marked and identified, 
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA-2019-D-4258 for ``Type V DMFs for CDER-Led Combination Products 
Using Device Constituent Parts With Electronics or Software.'' Received 
comments will be placed in the docket and, except for those submitted 
as ``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m. 
and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available, submit your comments only as a written/paper submission. You 
should submit two copies total. One copy will include the information 
you claim to be confidential with a heading or cover note that states 
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will 
review this copy, including the claimed confidential information, in 
its consideration of comments. The second copy, which will have the 
claimed confidential information redacted/blacked out, will be 
available for public viewing and posted on https://www.regulations.gov. 
Submit both copies to the Dockets Management Staff. If you do not wish 
your name and contact information to be made publicly available, you 
can provide this information on the cover sheet and not in the body of 
your comments and you must identify this information as 
``confidential.'' Any information marked as ``confidential'' will not 
be disclosed except in accordance with 21 CFR 10.20 and other 
applicable disclosure law. For more information about FDA's posting of 
comments to public dockets, see 80 FR 56469, September 18, 2015, or 
access the information at: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in 
the heading of this document, into the ``Search'' box and follow the 
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852.
    You may submit comments on any guidance at any time (see 21 CFR 
10.115(g)(5)).
    Submit written requests for single copies of the draft guidance to 
the Division of Drug Information, Center for Drug Evaluation and 
Research, Food and Drug Administration, 10001 New Hampshire Ave., 
Hillandale Building, 4th Floor, Silver Spring, MD 20993-0002. Send one 
self-addressed adhesive label to assist that office in processing your 
requests. See the SUPPLEMENTARY INFORMATION section for electronic 
access to the draft guidance document.

FOR FURTHER INFORMATION CONTACT: Kimberly Peters, Center for Drug 
Evaluation and Research, Food and Drug Administration, Bldg. 51, Rm. 
4314, 10903 New Hampshire Ave., Silver Spring, MD 20993, 301-796-6350.

SUPPLEMENTARY INFORMATION: 

I. Background

    FDA is announcing the availability of a draft guidance for industry 
entitled ``Type V DMFs for CDER-Led Combination Products Using Device

[[Page 57878]]

Constituent Parts With Electronics or Software.'' Some CDER-led 
combination products feature a device constituent part with electronics 
and/or software that may be used as a platform across multiple 
products. An application for such a combination product may necessitate 
review by multiple centers, offices, and divisions within FDA. In 
addition, because the device constituent part may be used as a platform 
in multiple CDER-led combination products, the same device information 
may be applicable to and used to support multiple CDER submissions. For 
such combination products, a Type V DMF can be an efficient mechanism 
to provide information regarding the device constituent part when the 
same information is applicable to several CDER applications, and 
additional measures to ensure consistency are needed.
    Further, because of rapid advances in technology, the device 
constituent part of these types of combination products could be 
modified frequently. Knowledge of these modifications is important in 
determining whether they have any impact on the safety and 
effectiveness of the combination product or its indications for use. 
Amendments to the Type V DMF provide a regulatory pathway for the DMF 
holder to report device modifications and for FDA to be notified of and 
to review device modifications.
    Once FDA reviews the Type V DMF device information for one CDER 
application, its review may be applicable to other CDER applications if 
the device information remains unchanged and is pertinent to products 
in other CDER applications that also incorporate the DMF by reference. 
FDA's ability to use previously completed scientific reviews for a DMF 
can contribute to an efficient FDA review process and help ensure 
consistency across CDER applications referencing the same information.
    This draft guidance applies to Type V DMF submissions as described 
above for CDER-led combination products. Specifically, the information 
in this draft guidance may be appropriate for device constituent parts 
with electronics and/or software that meet the statutory definition of 
a device and perform functions such as the following:
     Facilitate drug delivery in a manner that may include 
patient input or analysis (e.g., an electromechanically driven pen 
injector with software that allows input of patient or dosing 
information or that analyzes dosing or device use information).
     Provide information that is used in making a decision 
regarding treatment, therapy, or drug delivery.
     Interface with other devices or systems to provide patient 
use or other information to the user or health care provider (e.g., 
physiological parameters).
     Control or drive the features of the user interface.
    This draft guidance addresses process and general content 
expectations for Type V DMFs for such device constituent parts. It does 
not address FDA premarket review standards or expectations for such 
constituent parts or the combination products that include them. This 
draft guidance is also not intended to suggest that a Type V DMF should 
be submitted to CDER if the sponsor has rights of reference to a device 
master file located in another center containing the same information.
    This draft guidance is being issued consistent with FDA's good 
guidance practices regulation (21 CFR 10.115). The draft guidance, when 
finalized, will represent the current thinking of FDA on ``Type V DMFs 
for CDER-Led Combination Products Using Device Constituent Parts With 
Electronics or Software.'' It does not establish any rights for any 
person and is not binding on FDA or the public. You can use an 
alternative approach if it satisfies the requirements of the applicable 
statutes and regulations.

II. Paperwork Reduction Act of 1995

    This draft guidance refers to previously approved collections of 
information found in FDA regulations. These collections of information 
are subject to review by the Office of Management and Budget (OMB) 
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The 
collections of information in 21 CFR 314.420 have been approved under 
OMB control number 0910-0001.

III. Electronic Access

    Persons with access to the internet may obtain the draft guidance 
at either https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or 
https://www.regulations.gov.

    Dated: October 22, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-23585 Filed 10-28-19; 8:45 am]
BILLING CODE 4164-01-P