[Federal Register Volume 77, Number 156 (Monday, August 13, 2012)]
[Notices]
[Pages 48160-48162]
From the Federal Register Online via the Government Printing 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: 
Lindsay.pack@fda.hhs.gov.
    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: joyce.raines@fda.hhs.gov.
    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