Division of Cardiovascular Devices 30-Day Notices and Annual Reports; Public Workshop; Request for Comments, 48160-48162 [2012-19747]
Download as PDF
<![CDATA[
48160
Federal Register / Vol. 77, No. 156 / Monday, August 13, 2012 / Notices
mstockstill on DSK4VPTVN1PROD with NOTICES
Devices and Radiological Health, Food
and Drug Administration, 10903 New
Hampshire Ave., Bldg. 66, rm. 4613,
Silver Spring, MD 20993–0002; or Office
of Communication, Outreach and
Development (HFM–40), Center for
Biologics Evaluation and Research,
Food and Drug Administration, 1401
Rockville Pike, suite 200N, Rockville,
MD 20852–1448. Send one selfaddressed adhesive label to assist that
office in processing your request, or fax
your request to 301–847–8149. See the
SUPPLEMENTARY INFORMATION section for
information on electronic access to the
guidance.
Submit electronic comments on the
draft guidance to https://
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. Identify
comments with the docket number
found in brackets in the heading of this
document.
FOR FURTHER INFORMATION CONTACT:
Geeta Pamidimukkala, Center for
Devices and Radiological Health, Food
and Drug Administration, 10903 New
Hampshire Ave., Bldg. 66, rm. 1564,
Silver Spring, MD 20993–0002, 301–
796–6453; or Stephen Ripley, Center for
Biologics Evaluation and Research
(HFM–17), Food and Drug
Administration, 1401 Rockville Pike,
Suite 200N, Rockville, MD 20852–1448,
301–827–6210.
I. Background
The purpose of the 510(k) acceptance
review is to make a threshold
determination whether a submission is
administratively complete, which
determines whether it should be
accepted for substantive review to reach
a determination regarding substantial
equivalence under section 513(i) of the
FD&C Act, 21 U.S.C. 360c(i). To find a
device substantially equivalent under
section 513(i) of the FD&C Act, FDA
must find that it has the same intended
use as the predicate device, and either:
(1) Has the same technological
characteristics as the predicate device or
(2) has different technological
characteristics, as defined at section
513(i)(1)(B), and the submission
contains information, including
appropriate clinical or scientific data if
necessary, that demonstrates the device
is as safe and effective as the predicate
and does not raise different questions of
safety and effectiveness than the
predicate.
The purpose of this document is to
explain the procedures and criteria FDA
intends to use in determining whether
a 510(k) submission is administratively
VerDate Mar<15>2010
16:29 Aug 10, 2012
Jkt 226001
complete and should be accepted for
substantive review. This guidance
document provides updated information
to two existing guidance documents
entitled ‘‘Center for Devices and
Radiological Health’s Premarket
Notification (510(k)) Refuse to Accept
Policy’’ issued on June 30, 1993, and
‘‘510(k) Refuse to Accept Procedures,
510(k) Memorandum K94–1’’ issued on
May 20, 1994. Upon issuance as a final
guidance document, this guidance will
replace those documents.
To further focus the Agency’s review
resources on complete applications,
which will provide a more efficient
approach to ensuring that safe and
effective medical devices reach patients
as quickly as possible, we have
modified the 1993 and 1994 guidances.
For example, we have modified the
510(k) refuse to accept policy to include
an early review against specific
acceptance criteria and to inform the
submitter within the first 15 calendar
days of receipt of the submission if the
submission is administratively
complete, or if not, to identify the
missing element(s). In order to enhance
the consistency of our acceptance
decisions and to help submitters better
understand the types of information
FDA needs to conduct a substantive
review, this guidance, including the
checklists included in the appendices,
clarifies the necessary elements and
contents of a complete 510(k)
submission. These elements are
applicable to all devices reviewed
through the 510(k) notification process
in CDRH and CBER and have been
compiled into checklists for use by FDA
review staff.
II. Significance of Guidance
This draft guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The draft guidance, when finalized, will
represent the Agency’s current thinking
on the refuse to accept policy for
510(k)s. It does not create or confer any
rights for or on any person and does not
operate to bind FDA or the public. An
alternative approach may be used if
such approach satisfies the
requirements of the applicable statute
and regulations.
III. Electronic Access
Persons interested in obtaining a copy
of the draft guidance may do so by using
the Internet. A search capability for all
CDRH guidance documents is available
at https://www.fda.gov/MedicalDevices/
DeviceRegulationandGuidance/
GuidanceDocuments/default.htm.
Guidance documents are also available
at https://www.fda.gov/BiologicsBlood
PO 00000
Frm 00038
Fmt 4703
Sfmt 4703
Vaccines/GuidanceCompliance
RegulatoryInformation/default.htm or
https://www.regulations.gov.
To receive ‘‘Refuse to Accept Policy
for 510(k)s,’’ you may either send an
email request to dsmica@fda.hhs.gov to
receive an electronic copy of the
document or send a fax request to 301–
847–8149 to receive a hard copy. Please
use the document number 1793 to
identify the guidance you are
requesting.
IV. Paperwork Reduction Act of 1995
This draft guidance refers to currently
approved collections of information
found in FDA regulations. These
collections of information are 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 in
21 CFR part 807, subpart E, have been
approved under OMB control number
0910–0120.
V. Comments
Interested persons may submit to the
Division of Dockets Management (see
ADDRESSES), either electronic or written
comments regarding this document. 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. Received
comments may be seen in the Division
of Dockets Management between 9 a.m.
and 4 p.m., Monday through Friday.
Dated: August 7, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012–19744 Filed 8–10–12; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2012–N–0842]
Division of Cardiovascular Devices 30Day Notices and Annual Reports;
Public Workshop; Request for
Comments
AGENCY:
Food and Drug Administration,
HHS.
Notice of public workshop;
request for comments.
ACTION:
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
E:\FR\FM\13AUN1.SGM
13AUN1
mstockstill on DSK4VPTVN1PROD with NOTICES
Federal Register / Vol. 77, No. 156 / Monday, August 13, 2012 / Notices
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: https://www.
fda.gov/AboutFDA/WorkingatFDA/
BuildingsandFacilities/WhiteOak
CampusInformation/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 https://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
VerDate Mar<15>2010
16:29 Aug 10, 2012
Jkt 226001
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 https://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 https://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 https://
www.regulations.gov.
Transcripts: Please be advised that as
soon as a transcript is available, it will
be accessible at https://
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,
PO 00000
Frm 00039
Fmt 4703
Sfmt 4703
48161
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 https://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
E:\FR\FM\13AUN1.SGM
13AUN1
48162
Federal Register / Vol. 77, No. 156 / Monday, August 13, 2012 / Notices
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
National Institutes of Health
Announcement of Requirements and
Registration for the Challenge To
Identify Audacious Goals in Vision
Research and Blindness Rehabilitation
Authority: 15 U.S.C. 3719.
The National Eye Institute
(NEI) is announcing the launch of the
Challenge to Identify Audacious Goals
in Vision Research and Blindness
Rehabilitation (Challenge) to stimulate
innovation in establishing a national
vision research agenda. This Challenge
seeks entries from the general public,
not just those typically engaged in
vision research. The challenge calls for
submission of audacious goals in any
area relevant to NEI’s mission to
conduct and support research, training,
health information dissemination, and
other programs with respect to blinding
eye diseases, visual disorders,
mechanisms of visual function,
preservation of sight, and the special
health problems and requirements of the
blind (42 U.S.C. 285i).
The NEI will select up to 20 winners
to receive a $3,000 cash prize and will
host the winners at the NEI Audacious
Goals Development Meeting to present
and discuss their winning entries with
a broad audience of scientists, NEI staff,
and other stakeholders. This challenge
will generate valuable contributions
from NEI’s many and varied
stakeholders to inform the Institute’s
strategic plan, energize the Institute’s
research efforts, increase public
awareness of vision research, and
enhance the national effort to reduce the
burden of ocular disorders and diseases
worldwide.
mstockstill on DSK4VPTVN1PROD with NOTICES
SUMMARY:
16:29 Aug 10, 2012
(1) Submission period begins August
13, 2012.
(2) Submission period ends November
12, 2012, 6:00 p.m. ET.
(3) Winners notified January 7, 2013.
(4) Winners present and discuss their
winning entry at the NEI Audacious
Goals Development Meeting in early
2013 (date will be announced on
https://www.nei.nih.gov/challenge).
FOR FURTHER INFORMATION CONTACT:
Richard S. Fisher, Ph.D., Associate
Director for Science Policy and
Legislation, National Eye Institute,
Phone: 301–496–4308. [NEIPlan@mail.
nih.gov.]
SUPPLEMENTARY INFORMATION:
Subject of Challenge Competition
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
VerDate Mar<15>2010
DATES:
Jkt 226001
This Challenge to Identify Audacious
Goals in Vision Research and Blindness
Rehabilitation (Challenge) adds an
exciting, unique component to the NEI’s
current strategic planning effort. In the
past, these planning efforts relied
primarily on the expertise of NEIfunded scientists to review the state of
the science and describe current specific
research needs and opportunities. This
Challenge seeks input from all eligible
individuals (Contestants)—not just
vision research scientists—to describe
(a) an audacious goal in vision research
and blindness rehabilitation, (b) how to
achieve the goal within about 10 years,
and (c) the impact of reaching the goal.
Rules for Participating in the
Competition
1. Eligibility: To be eligible to win a
prize under this Challenge, a Contestant:
Æ Shall have registered to participate
in the competition under the rules
promulgated by the NEI and explained
in this Notice;
Æ Shall have complied with all the
requirements under this section;
Æ Shall be an individual at least 18
years of age and shall be a citizen or
permanent resident of the United States;
Æ May not be a Federal entity or
Federal employee acting within the
scope of their employment. Federal
employees seeking to participate in this
contest outside the scope of their
employment should consult their ethics
official prior to developing their
submission;
Æ May not be employees of the NIH
or any other company or individual
involved with the design, production,
execution, judging, or distribution of the
Challenge and their immediate family
(spouse, parents and step-parents,
siblings and step-siblings, and children
and step-children) and household
members (people who share the same
PO 00000
Frm 00040
Fmt 4703
Sfmt 4703
residence at least three (3) months out
of the year);
2. Federal grantees may not use
Federal funds to develop America
COMPETES Act Challenge applications
unless consistent with the purpose of
their grant award (Grantees should
consult with their cognizant Grants
Management Official to make this
determination); and
3. Federal contractors may not use
Federal funds from a contract to develop
a Challenge entry or to fund efforts in
support of a Challenge submission.
4. A Contestant shall not be deemed
ineligible because the individual used
Federal facilities or consulted with
Federal employees during a competition
if the facilities and employees are made
available to all individuals participating
in the competition on an equitable basis.
5. Liability: By participating in this
Challenge, Contestants agree to assume
any and all risks and waive claims
against the Federal Government and its
related entities, except in the case of
willful misconduct, for any injury,
death, damage, or loss of property,
revenue, or profits, whether direct,
indirect, or consequential, arising from
participation in this prize contest,
whether the injury, death, damage, or
loss arises through negligence or
otherwise.
6. Indemnification: By participating in
this Challenge, Contestants agree to
indemnify the Federal Government
against third party claims for damages
arising from or related to competition
activities.
7. Insurance: Based on the subject
matter of the contest, the type of work
that it will possibly require, as well as
an analysis of the likelihood of any
claims for death, bodily injury, or
property damage, or loss potentially
resulting from contest participation,
Contestants are not required to obtain
liability insurance or demonstrate
financial responsibility in order to
participate in this contest.
8. By participating in this Challenge,
each individual agrees to abide by all
rules set forth in this Notice and the
Challenge.gov Terms of Participation
(https://challenge.gov/terms).
9. Each Entry Must:
Æ Be limited to a maximum of 4,000
characters, including spaces (roughly a
single page). In addition to information
requested by https://www.nei.nih.gov/
challenge to identify the entry,
Contestants must complete three
statements about the proposed
audacious goal. The following
statements, which will be the subject of
the judging, are:
D It would be fantastic if * * *’’
(Explain why the goal is audacious and
E:\FR\FM\13AUN1.SGM
13AUN1
]]>Agencies
[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]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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
[[Page 48161]]
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: https://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 https://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 https://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 https://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 https://www.regulations.gov.
Transcripts: Please be advised that as soon as a transcript is
available, it will be accessible at https://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
https://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
[[Page 48162]]
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
