Document ID: FDA-2013-D-1279-0011
Agency: fda
Document Type: Notice
Title: Qualification of Medical Device Development Tools; Guidance for Industry, Tool Developers, and Food and Drug Administration Staff; Availability
Posted Date: 2017-08-10T04:00Z

[Federal Register Volume 82, Number 153 (Thursday, August 10, 2017)]
[Notices]
[Pages 37456-37458]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-16827]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-D-1279]

Qualification of Medical Device Development Tools; Guidance for 
Industry, Tool Developers, and Food and Drug Administration Staff; 
Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing 
the availability of the guidance entitled ``Qualification of Medical 
Device Development Tools (MDDT).'' This document formalizes the MDDT 
program and provides guidance to FDA staff, industry, healthcare 
providers, researchers, and patient and consumer groups on a new 
voluntary process within the Center for Devices and Radiological Health 
(CDRH) for qualification of medical device development tools (MDDT) for 
use in device development and evaluation programs. In addition, the 
guidance discusses the framework of an MDDT, including definitions of 
applicable terms, criteria for evaluating an MDDT for a specific 
context of use, considerations for qualification, and the contents of a 
qualification package. FDA considered comments on the draft guidance 
and revised the guidance as appropriate.

DATES: Submit either electronic or written comments on this guidance at 
any time. General comments on Agency guidance documents are welcome at 
any time.

ADDRESSES: You may submit comments 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.''

[[Page 37457]]

    Instructions: All submissions received must include the Docket No. 
FDA-2013-D-1279 for ``Qualification of Medical Device Development 
Tools.'' 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.
    An electronic copy of the guidance document is available for 
download from the Internet. See the SUPPLEMENTARY INFORMATION section 
for information on electronic access to the guidance. Submit written 
requests for a single hard copy of the guidance document entitled 
``Qualification of Medical Device Development Tools'' to the Office of 
the Center Director, Guidance and Policy Development, Center for 
Devices and Radiological Health, Food and Drug Administration, 10903 
New Hampshire Ave., Bldg. 66, Rm. 5431, Silver Spring, MD 20993-0002. 
Send one self-addressed adhesive label to assist that office in 
processing your request.

FOR FURTHER INFORMATION CONTACT: Kathryn O'Callaghan, Center for 
Devices and Radiological Health, Food and Drug Administration, 10903 
New Hampshire Ave., Bldg. 66, Rm. 5418, Silver Spring, MD 20993-0002, 
(301) 796-6349.

SUPPLEMENTARY INFORMATION:

I. Background

    MDDT is a scientifically validated tool that aids device 
development and regulatory evaluation. The guidance describes the 
framework and process for the voluntary CDRH qualification of MDDT, 
including definitions of applicable terms, criteria for evaluating a 
MDDT for a specific context of use, the threshold for qualification, 
and the contents of a qualification submission.
    The intent of this voluntary qualification policy is to: (1) Enable 
faster, more efficient development of important life-saving and health 
promoting medical devices, (2) promote the development of tools to 
facilitate more timely device evaluation, (3) provide a mechanism to 
better leverage advances in regulatory science, and (4) more quickly 
and more clearly communicate with CDRH stakeholders about important 
advances in regulatory science that may be leveraged to speed device 
development and regulatory evaluation. CDRH expects the qualification 
process to expedite development of publicly available tools, which 
could potentially be used widely in multiple device development 
programs.
    The intent of this voluntary MDDT program is to promote the 
development and use of tools to streamline device development and 
evaluation. Once an MDDT is submitted in accordance with the FDA 
guidance entitled ``Requests for Feedback on Medical Device 
Submissions: The Pre-Submission Program and Meetings with Food and Drug 
Administration Staff'' (Ref. 1) and qualified for a specific context of 
use, it can be used by any medical device sponsor for that context of 
use. MDDTs can be used for the qualified context of use without the 
need to reconfirm the suitability and utility of the MDDT when used in 
a premarket submission. Qualification may contribute to acceptance and 
application of MDDTs across multiple medical device development 
programs. Qualified MDDTs can be utilized by many sponsors to aid in 
optimizing device development and evaluation.
    As discussed in the November 14, 2013, Federal Register notice (78 
FR 68459), FDA announced the availability of the draft of this guidance 
and interested persons were invited to comment by February 12, 2014. In 
the August 15, 2014, Federal Register notice (79 FR 48170), FDA began 
accepting nominations for participation in the voluntary MDDT Pilot 
Program. FDA reviewed and considered all public comments received and 
revised this guidance as appropriate.

II. Significance of Guidance

    This guidance is being issued consistent with FDA's good guidance 
practices regulation (21 CFR 10.115). The guidance represents the 
current thinking of FDA on ``Qualification of Medical Device 
Development Tools.'' 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. This guidance is not subject to Executive Order 12866.

III. Electronic Access

    Persons interested in obtaining a copy of the guidance may do so by 
downloading an electronic copy from the Internet. A search capability 
for all Center for Devices and Radiological Health guidance documents 
is available at https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm. Guidance 
documents are also available at https://www.regulations.gov. Persons 
unable to download an electronic copy of ``Qualification of Medical 
Device Development Tools'' may send an email request to CDRH-Guidance@fda.hhs.gov to receive an electronic copy of the document. 
Please use the document number 1882 to identify the guidance you are 
requesting.

IV. Paperwork Reduction Act of 1995

    This guidance contains information collection that is 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 under the guidance entitled ``Requests for Feedback on 
Medical Device Submissions: The Pre-Submission Program and Meetings 
with Food and Drug Administration Staff'' have been approved under OMB 
control number 0910-0756.

[[Page 37458]]

V. Reference

    The following reference is on display in the Dockets Management 
Staff (see ADDRESSES) and is available for viewing by interested 
persons between 9 a.m. and 4 p.m., Monday through Friday; it is also 
available electronically at https://www.regulations.gov. FDA has 
verified the Web site address, as of the date this document publishes 
in the Federal Register, but Web sites are subject to change over time.

1. FDA Guidance, ``Requests for Feedback on Medical Device 
Submissions: The Pre-Submission Program and Meetings with Food and 
Drug Administration Staff.'' Available at https://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM311176.pdf.

    Dated: August 4, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-16827 Filed 8-9-17; 8:45 am]
BILLING CODE 4164-01-P