[Federal Register Volume 77, Number 156 (Monday, August 13, 2012)]
[Notices]
[Pages 48160-48162]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-19747]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2012-N-0842]
Division of Cardiovascular Devices 30-Day Notices and Annual
Reports; Public Workshop; Request for Comments
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of public workshop; request for comments.
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The Food and Drug Administration (FDA) is announcing the following
public workshop entitled ``Division of Cardiovascular Devices 30-Day
Notices and Annual Reports.'' This public workshop will be cosponsored
with Advanced Medical Technology Association (AdvaMed). The purpose of
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this public workshop is to discuss details of, and issues relating to,
two types of reporting requirements applicable to premarket approval
applications (PMAs), 30-day notices and annual reports, specifically
for cardiovascular devices.
DATES: Date and Time: The public workshop will be held on August 28,
2012, from 8 a.m. to 5 p.m.
Location: The public workshop will be held at FDA's White Oak
Campus, 10903 New Hampshire Ave., Bldg. 31 Conference Center, the Great
Room (rm. 1503), Silver Spring, MD 20993. Entrance for the public
workshop participants (non-FDA employees) is through Building 1 where
routine security check procedures will be performed. For parking and
security information, please refer to: http://www.fda.gov/AboutFDA/WorkingatFDA/BuildingsandFacilities/WhiteOakCampusInformation/ucm241740.htm.
Contact: Lindsay K. Pack, Center for Devices and Radiological
Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
66, rm. 1260, Silver Spring, MD 20993, 301-796-5214, email:
[email protected].
Registration: Registration is free and available on a first-come,
first-served basis. Persons interested in attending this public
workshop must register online by 5 p.m., August 17, 2012. Early
registration is recommended because facilities are limited and,
therefore, FDA may limit the number of participants from each
organization. If time and space permits, onsite registration on the day
of the public workshop will be provided beginning at 7 a.m.
If you need special accommodations due to a disability, please
contact Joyce Raines, Center for Devices and Radiological Health, Food
and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, rm. 4319,
Silver Spring, MD 20993, 301-796-5709, email: [email protected].
To register for the public workshop, please visit FDA's Medical
Devices News & Events--Workshops & Conferences calendar at http://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/default.htm.
(Select this public workshop from the posted events list.) Please
provide complete contact information for each attendee, including name,
title, affiliation, address, email, and telephone number. Those without
Internet access should contact Lindsay Pack to register (see Contact).
Registrants will receive confirmation after they have been accepted.
You will be notified if you are on a waiting list.
Streaming Webcast of the Public Workshop: This public workshop will
also be webcast. Persons interested in viewing the webcast must
register online by 5 p.m., August 17, 2012. Early registration is
recommended because webcast connections are limited. Organizations are
requested to register all participants, but to view using one
connection per location. Webcast participants will be sent technical
system requirements after registration and will be sent connection
access information after August 22, 2012. If you have never attended a
Connect Pro event before, test your connection at https://collaboration.fda.gov/common/help/en/support/meeting_test.htm. To get
a quick overview of the Connect Pro program, visit http://www.adobe.com/go/connectpro_overview. (FDA has verified the Web site
addresses in this document, but FDA is not responsible for any
subsequent changes to the Web sites after this document publishes in
the Federal Register.)
Comments: FDA is holding this public workshop to discuss issues
related to 30-day notices and annual reporting requirements as they
pertain to manufacturing changes to class III cardiovascular devices
that are the subject of a PMA. In order to permit the widest possible
opportunity to obtain public comment, FDA is soliciting either
electronic or written comments on all aspects of the public workshop
topics. The deadline for submitting comments related to this public
workshop is September 26, 2012.
Regardless of attendance at the public workshop, interested persons
may submit either electronic or written comments. Submit electronic
comments to http://www.regulations.gov. Submit written comments to the
Division of Dockets Management (HFA-305), Food and Drug Administration,
5630 Fishers Lane, rm. 1061, Rockville, MD 20852. It is only necessary
to send one set of comments. Please identify comments with the docket
number found in brackets in the heading of this document. Received
comments may be seen in the Division of Dockets Management between 9
a.m. and 4 p.m., Monday through Friday and will be posted to the docket
at http://www.regulations.gov.
Transcripts: Please be advised that as soon as a transcript is
available, it will be accessible at http://www.regulations.gov. It may
be viewed at the Division of Dockets Management (see Comments). A
transcript will also be available in either hardcopy or on CD-ROM,
after submission of a Freedom of Information request. Written requests
are to be sent to the Division of Freedom of Information (ELEM-1029),
Food and Drug Administration, 12420 Parklawn Dr., Element Bldg.,
Rockville, MD 20857. A link to the transcripts will also be available
approximately 45 days after the public workshop on the Internet at
http://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/default.htm. (Select this public workshop from the posted events list.)
SUPPLEMENTARY INFORMATION:
I. Background
Under section 515(d)(6)(A) of the Federal Food, Drug, and Cosmetic
Act (section 360e(d)(6)(A) of the FD&C Act) and 21 CFR 814.39(a), PMA
supplements are required for any change to a device subject to an
approved application that affects safety or effectiveness, unless such
change is a modification in a manufacturing procedure or method of
manufacturing. Under the FD&C Act and 21 CFR 814.39(f), changes in
manufacturing procedures or methods of manufacture that affect the
safety or effectiveness of the device require a 30-day notice (however,
if FDA finds that the notice is inadequate, a supplement will be
required). Additionally, under 21 CFR 814.39(b), a manufacturer may
make a change to a device after FDA's approval of a PMA for the device
without submitting a PMA supplement if the change does not affect the
safety or effectiveness of the device and the change is reported to FDA
in a post approval periodic (annual) report.
This workshop is intended to focus on manufacturing method and
procedure changes to Class III cardiovascular devices, which could be
submitted to FDA in a 30-day notice or annual report, depending on the
change. A guidance document issued on April 13, 2011, entitled ``30-Day
Notices, 135-Day Premarket Approval (PMA) Supplements and 75-Day
Humanitarian Device Exemption (HDE) Supplements for Manufacturing
Method or Process Changes'' outlines FDA's current thinking on which
changes may qualify for a 30-day notice and which changes may require
other submission types (supplements, annual reports, etc.). This
workshop will allow a deeper discussion of relevant considerations when
determining the appropriate submission for manufacturing changes to
Class III cardiovascular devices.
II. Topics for Discussion at the Public Workshop
FDA is holding this public workshop to discuss a variety of issues
relating to two types of reporting requirements applicable to PMAs, 30-
day notices and annual reports, specifically for
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cardiovascular devices. These issues include, but are not limited to:
Considerations that go into determining if a change is
appropriate for an annual report or 30-day notice (e.g., equipment
changes, software changes, supplier changes);
Best practices for submission contents;
Other issues and questions raised by the public workshop
attendees that are relevant to 30-day notices and annual reports for
cardiovascular devices.
Dated: August 7, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012-19747 Filed 8-10-12; 8:45 am]
BILLING CODE 4160-01-P