[Federal Register Volume 77, Number 162 (Tuesday, August 21, 2012)]
[Pages 50514-50515]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-20469]



Food and Drug Administration

[Docket No. FDA-2012-N-0891]

Post-Approval Studies 2012 Workshop: Design, Methodology, and 
Role in Evidence Appraisal Throughout the Total Product Life Cycle; 
Public Workshop; Request for Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public workshop; request for comments.


SUMMARY: The Food and Drug Administration (FDA) is announcing the 
following public workshop entitled ``Post-Approval Studies 2012 
Workshop: Design, Methodology, and Role in Evidence Appraisal 
Throughout the Total Product Life Cycle.'' The topics of discussion 
will include lessons learned from previous experiences with post-
approval studies, improvement of implementation strategies for post-
approval studies, best practices, and innovative methodologies for 
evidence appraisal.
    Date and Time: The public workshop will be held on August 30, 2012, 
from 8 a.m. to 5 p.m.
    Location: The public workshop will be held at the FDA 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 Persons: Nilsa Loyo-Berrios, Center for Devices and 
Radiological Health (CDRH), Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 66, Rm. 3214, Silver Spring, MD 20993, 301-796-
8528, email: Nilsa.Loyo-Berrios @fda.hhs.gov or Danica Marinac-Dabic, 
Center for Devices and Radiological Health, Food and Drug 
Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 4110, Silver 
Spring, MD 20993, 301-796-6689, 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. on August 23, 2012. Early 
registration is recommended because facilities are limited and, 
therefore, FDA may limit the number of participants from each 
organization. Onsite registration will not be available on the day of 
the public workshop.
    If you need special accommodations due to a disability, please 
contact Cindy Garris, Center for Devices and Radiological Health, Food 
and Drug Administration, 10903 New Hampshire Ave., Bldg., 66, Rm. 4321, 
Silver Spring, MD 20993, 301-796-5861, 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,

[[Page 50515]]

and telephone number. Those without Internet access should contact 
Nilsa Loyo-Berrios to register (see Contact Persons). 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. on August 28, 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. Web cast participants will be sent technical 
system requirements after registration and will be sent connection 
access information after August 23, 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 provide an update 
and obtain stakeholders input on post-approval studies ordered at the 
time of device approval. 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 30, 2012.
    Regardless of attendance at the public workshop, interested persons 
may submit either written comments regarding this document to the 
Division of Dockets Management (HFA-305), Food and Drug Administration, 
5630 Fishers Lane, Rm. 1061, Rockville, MD 20852 or electronic comments 
to http://www.regulations.gov. It is only necessary to send one set of 
comments. Identify comments with the docket number found in brackets in 
the heading of this document. In addition, when responding to specific 
questions as outlined in section II of this document, please identify 
the question you are addressing. 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).


I. Background

    Post-approval studies (PAS) are imposed as conditions of approval 
for some class III devices regulated under premarket approval (PMA) 
regulations and are an important public health tool for developing 
additional evidence on device performance in the postmarket setting. In 
order for PAS to be most effective, studies must be well-designed, 
scientifically sound, meaningful and feasible, and must provide 
complete and timely information. PMA conditions of approval studies are 
constructed to ask for specific, detailed data in a subsequent PAS 
relating to unanswered questions in premarket data. However, there are 
often opportunities for leveraging the design and conduct of PAS, 
enhancing its utility to other important stakeholders. In addition to 
the direct role of PMA holders, the role of other public health 
partners is expanding, as evidenced by a number of efforts external to 
CDRH that are directly or indirectly involved in collecting and 
analyzing data relevant to estimating medical device use and risk and 
in communicating risk to target populations. To ensure a successful PAS 
program, CDRH, regulated industry, clinical researchers, and other 
stakeholders must remain well-informed and engaged in continuous 
dialogue regarding the design, implementation, reporting, and use of 
PAS and the resultant data. Further, it is the Center's desire to 
ensure this dialogue results in studies that maximize the public health 
impact by producing data that is informative to a range of 

II. Topics for Discussion at the Public Workshop

    We intend to discuss a large number of issues at the workshop, 
including, but not limited to the following: (1) PAS within the Total 
Product Life Cycle, (2) best practices and improvement of PAS 
implementation strategies, (3) PAS impact on public health and medical 
device innovation, and (4) opportunities for innovative uses of PAS 

    Dated: August 15, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012-20469 Filed 8-20-12; 8:45 am]