Arch Therapeutics Inc (ARTH)

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[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 FDA considered comments on the draft guidance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,
[phone].

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 [e-mail] 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

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