Center for Devices and Radiological Health Participation in International Medical Device Regulators Forum, Regulated Product Submission, Table of Contents Pilot Program, 50293-50295 [2015-20430]
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Federal Register / Vol. 80, No. 160 / Wednesday, August 19, 2015 / Notices
Legislation, and Analysis, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 32, Rm. 3330,
Silver Spring, MD 20993–0002, 301–
796–9115.
SUPPLEMENTARY INFORMATION: In FR Doc.
2014–13290, appearing on page 32964,
in the Federal Register of Monday, June
9, 2014, the following correction is
made:
On page 32964, in the second column,
in the headings section of the document,
[Docket No. FDA–2014–N–0736]’’ is
corrected to read ‘‘FDA–2015–N–2781’’.
Please be aware that this new docket
is no longer open for comment.
Dated: August 12, 2015.
Jill Hartzler Warner,
Associate Commissioner for Special Medical
Programs.
[FR Doc. 2015–20397 Filed 8–18–15; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2015–N–2458]
Center for Devices and Radiological
Health Participation in International
Medical Device Regulators Forum,
Regulated Product Submission, Table
of Contents Pilot Program
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration’s (FDA) Center for
Devices and Radiological Health
(CDRH), Offices of Device Evaluation
(ODE) and In Vitro Diagnostics and
Radiation (OIR) are announcing their
participation in the International
Medical Device Regulators Forum’s
(IMDRF) Regulated Product Submission
Table of Contents Pilot Program.
Participation in the Pilot is voluntary
and open to applicants who submit
premarket approval (PMA) applications
or premarket notification (510(k)) to
either ODE or OIR. The Pilot project is
intended to provide industry, IMDRF,
and CDRH staff the opportunity to
evaluate the Table of Contents structure
and to receive input from industry
participants. Participants will be asked
to submit their submissions
electronically using IMDRF’s Table of
Contents (ToC) format.
DATES: The IMDRF is seeking interest
for participation in the voluntary
IMDRF Regulated Product Submission,
Table of Contents Pilot Program. See
section II.A. for instructions on how to
tkelley on DSK3SPTVN1PROD with NOTICES
SUMMARY:
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submit a request to participate. The
Pilot project will accept submissions
with the ToC structure starting
September 2015 through September
2016.
Jodi
Hope N. Anderson, Center for Devices
and Radiological Health, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 1520, Silver Spring,
MD 20993, 301–796–9299,
Jodi.Anderson@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
FOR FURTHER INFORMATION CONTACT:
I. Background
The IMDRF was conceived in
February 2011 as a forum to discuss
future directions in medical device
regulatory harmonization. It is a
voluntary group of medical device
regulators from around the world who
have come together to build on the
strong foundational work of the Global
Harmonization Task Force. The Forum
aims to accelerate international medical
device regulatory harmonization and
convergence.
The Regulated Product Submission
(RPS) proposal was endorsed as a new
work item by IMDRF at its 2012
inaugural meeting in Singapore. The
Work Group, consisting of regulatory
authorities from the United States,
European Union (EU), Australia, Brazil,
Japan, China, and Canada, created a
comprehensive Table of Contents for
Non-In Vitro Diagnostics (nIVD) and
also for IVD Marketing Authorizations,
which were formalized in August 2014.
The ToC provides a comprehensive
submission structure that can be used as
a harmonized international electronic
submission format while minimizing
regional divergences and indicating
where regional variation exists. This
document is intended to provide
guidance regarding the location of
submission elements. These documents
can be found on IMDRF’s Web site
(Refs. 1 and 2).
This document is intended to work
together with a regional classification
matrix, a separate document created for
each participating jurisdiction. The
classification matrix defines whether a
heading is required, not required,
optional, conditionally required, etc.,
for the given submission type. FDA’s
Classification Matrices can be found on
FDA’s Web site (Ref. 3).
The ToC Work Group has previously
conducted Pilots for both of the ToC
structures, using historical submissions.
These Pilots provided valuable feedback
regarding the ToC structure and
completeness; however, there were
limitations to using historical
submissions and also a limited number
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50293
of samples involving submission to
more than one jurisdiction.
Furthermore, there were no specific
guidelines regarding the means of
building a submission in a non-standard
implementation. Additional IMDRF
testing is considered necessary to both
evaluate the ToC structures using real
regulatory submissions and also
evaluate the ToC structure from an
industry perspective.
II. CDRH Participation in IMDRF
Regulated Product Submission Table of
Contents (ToC) Implementation Pilot
FDA’s participation in the IMDRF
RPS ToC Implementation Pilot will
provide both local and international
benefits for FDA, as it will provide FDA
feedback into decisions regarding the
ToC’s suitability.
CDRH is participating in the Pilot. In
doing so, CDRH will receive premarket
submissions from the medical device
regulated industry using the IMDRF ToC
and FDA Regional Classification
Matrices. Applications are to be real
regulatory submissions—either PMAs or
510(k) applications—that will result in
regulatory decisions by CDRH. PMAs
exclude combination products and
bundled submissions. The 510(k)s
exclude special, abbreviated, and thirdparty submissions, as well as
combination products, bundled
submissions, and amendments after a
final decision. Pilot participation
requires that an application submitted
to FDA also be submitted sequentially
or simultaneously to at least one
additional participating IMDRF region.
Currently the participating regulating
authorities are Australia (Therapeutic
Goods Administration), Brazil
(ANVISA), Canada (Health Canada),
China (China Food and Drug
Administration), and the European
Union (Notified Bodies).
The Pilot is described in greater detail
in the IMDRF/RPS WG/N26
Informational Document ‘‘IMDRF Table
of Contents (ToC) Pilot Plan’’ (Ref. 4).
The Regulators participating in this
Pilot intend to use submissions only for
the requested regulatory activity and
objectives of this Pilot. Any submissions
generated in relation to this testing will
not be distributed to other
manufacturers or other regulators.
Industry participants should share any
submission content directly with the
appropriate regulators through the
official regulatory processes in place—
i.e., submission content will be shared
across regulators directly by regulated
industry.
Feedback provided on the ToC
structure, experience developing
regulatory submissions, or suggestions
E:\FR\FM\19AUN1.SGM
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Federal Register / Vol. 80, No. 160 / Wednesday, August 19, 2015 / Notices
tkelley on DSK3SPTVN1PROD with NOTICES
for additional ToC headings may be
shared and made public, excluding any
confidential content. Basic applicant
and submission identifying information
(e.g., Applicant/Correspondent/
Manufacturer Name, Device Name,
Device Type, and Submission Type)
will be shared among IMDRF Regulators
for the purpose of conducting the Pilot.
The invitation to participants will
provide the specific details of the
information to be shared among the
Regulators as it is a condition for Pilot
participation. Any information provided
in the resulting Pilot findings should
only disclose information explicitly
stated as releasable.
This Pilot will be evaluated in
accordance with current FDA protocols
and performance standards. Feedback
from reviewers will be provided on the
reviewability of the submission, based
on the IMDRF ToC and FDA
classification matrix, and any
observations regarding issues in the
submission content elements of the ToC
Pilot. Feedback from industry will be
accepted throughout the submission
building process.
The Pilot project is intended to
provide industry, IMDRF, and CDRH
staff the opportunity to evaluate the ToC
structure, through the receipt of input
from industry participants and CDRH
staff. Comments received during the
Pilot project will be used to evaluate the
usability of the ToC format. FDA will be
reviewing the contents of each
submission as part of this Pilot;
however, Pilot participation for the
manufacturer will end after successfully
passing the refuse to accept criteria.
Subsequently, a complete scientific
review, outside of the scope of the Pilot,
will commence.
A. Participation
Volunteers interested in participating
in the Pilot project should provide
expressions of interest to the IMDRF
ToC working group at the IMDRF ToC
email account imdrftoc@gmail.com.
Confirmation of your interest in
participation in the IMDRF ToC Pilot
plan is requested. If notification is
received by August 21, 2015, then the
manufacturer will be invited to
participate in a ‘‘participation
teleconference’’ to answer remaining
questions. After August 21, 2015,
contact FDA Pilot staff by email at
Jodi.Anderson@fda.hhs.gov with any
questions. The following information
should be included in the request:
Applicant, trade name, primary product
code, submission type, contact name,
and contact email. FDA will contact
interested applicants to discuss the Pilot
project. FDA is seeking a limited
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number of participants (no more than
nine) to participate in this Pilot project.
Participants must adhere to FDA’s
submission requirements (i.e., eCopy)
and Refuse to Accept (RTA)
requirements (Refs. 5 and 6).
B. Procedures
After reading the ToC Pilot Plan
document, applicants use either the
nIVD or IVD ToC documents, as well as
the respective Classification Matrix to
construct their submission. The
submission, placed into a single .zip file
with the name ‘‘MISC FILES.zip’’ is
then loaded onto media via eCopy (e.g.,
CD, DVD, SD card, USB drive). No paper
copy of the submission is needed. All
submissions are still expected to comply
with the respective PMA or 510(k) RTA
guidance documents. All submissions
are still expected to comply with the
FDA’s eCopy Program for Medical
Device Submissions Final Guidance
(Ref. 5), except for the following: (1)
With the exception of the cover letter,
all sections discussing paper copy
requirements may be disregarded; (2)
sections outside the scope of the Pilot
(e.g., sections pertaining to Bundled
Submissions) may be disregarded; and
(3) Attachment A, Part B of the eCopy
Guidance is superseded by the ToC
document. Applicants are required to
provide a paper cover letter, meeting the
technical guidance provided in the
eCopy Guidance Document, Attachment
1, Part A. In addition, the following
statement must be included in bold:
This submission is part of the IMDRF
ToC Pilot, and is organized according to
the IMDRF ToC. Accordingly, special
eCopy processing applies. As per the
agreement for this ToC Pilot, no full
paper copies are required, and the
specially-formatted submission is
zipped and placed within a MISC FILES
folder in the eCopy.
The cover letter and media should be
sent via mail to the Document Control
Center (DCC) to: Food and Drug
Administration, Center for Devices and
Radiological Health, Document Control
Center, Bldg. 66, Rm. G609, 10903 New
Hampshire Ave., Silver Spring, MD
20993–0002 ATTN: IMDRF ToC Pilot
Submission.
During the Pilot, CDRH staff will be
available to answer any questions or
concerns that may arise. Pilot project
participants will be asked to comment
on and discuss their experiences with
the Pilot submissions process. Their
input and discussions will assist both
IMDRF and CDRH in their use of the
ToC in future electronic submission
formats.
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III. Duration of the IMDRF Regulated
Product Submission ToC
Implementation Pilot
FDA intends to accept requests for
participation in the IMDRF’s Regulated
Product Submission, ToC
Implementation Pilot for 12 months,
from September 2015 through
September 2016. This Pilot program
may be extended as resources and needs
allow.
IV. Paperwork Reduction Act of 1995
This notice refers to previously
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.FDAC.
3501–3520). The collections of
information in 21 CFR part 807, subpart
E have been approved under OMB
control number 0910–0120 and the
collections of information in 21 CFR
part 814, subparts A through E have
been approved under OMB control
number 0910–0231.
V. References
The following references have been
placed on display in the Division of
Dockets Management (HFA–305), Food
and Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852,
and may be seen by interested persons
between 9 a.m. and 4 p.m., Monday
through Friday, and are available
electronically at https://
www.regulations.gov. (FDA has verified
all the Web site addresses in this
reference section, but we are not
responsible for any subsequent changes
to the Web sites after this document
publishes in the Federal Register.)
1. IMDRF Non-In Vitro Diagnostic Device
Market Authorization Table of Contents
(nIVD MA ToC) Final Document,
https://www.imdrf.org/docs/imdrf/final/
technical/imdrf-tech-140630-rps-nivdtoc.pdf.
2. IMDRF In Vitro Diagnostic Device Market
Authorization Table of Contents (IVD
MA ToC) Final Document, https://
www.imdrf.org/docs/imdrf/final/
technical/imdrf-tech-140630-rps-ivd-toc.
pdf.
3. FDA/IMDRF Documents, Regulated
Product Submission (RPS) Work Item,
https://www.fda.gov/MedicalDevices/
InternationalPrograms/IMDRF/
ucm417027.htm.
4. IMDRF Table of Contents (ToC) Pilot Plan,
https://www.imdrf.org/docs/imdrf/final/
procedural/imdrf-proc-150708-toc-pilotplan.pdf.
5. FDA’s eCopy Program for Medical Device
Submissions Final Guidance, October 10,
2013, https://www.fda.gov/downloads/
MedicalDevices/DeviceRegulationand
Guidance/GuidanceDocuments/
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Federal Register / Vol. 80, No. 160 / Wednesday, August 19, 2015 / Notices
UCM313794.pdf.
6. FDA’s Refuse to Accept Policy for 510(k)s
Final Guidance, December 31, 2012,
https://www.fda.gov/downloads/
MedicalDevices/DeviceRegulationand
Guidance/GuidanceDocuments/
UCM315014.pdf.
Dated: August 13, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015–20430 Filed 8–18–15; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2015–N–0001]
Arthritis Advisory Committee; Notice
of Meeting
AGENCY:
Food and Drug Administration,
HHS.
tkelley on DSK3SPTVN1PROD with NOTICES
ACTION:
Notice.
This notice announces a forthcoming
meeting of a public advisory committee
of the Food and Drug Administration
(FDA). The meeting will be open to the
public.
Name of Committee: Arthritis
Advisory Committee.
General Function of the Committee:
To provide advice and
recommendations to the Agency on
FDA’s regulatory issues.
Date and Time: The meeting will be
held on October 23, 2015, from 8 a.m.
to 5 p.m.
Location: FDA White Oak Campus,
10903 New Hampshire Ave., Bldg. 31
Conference Center, the Great Room (Rm.
1503), Silver Spring, MD 20993–0002.
Answers to commonly asked questions
including information regarding special
accommodations due to a disability,
visitor parking, and transportation may
be accessed at: https://www.fda.gov/
AdvisoryCommittees/
AboutAdvisoryCommittees/
ucm408555.htm.
Contact Person: Philip Bautista,
Center for Drug Evaluation and
Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 31, Rm. 2417, Silver Spring,
MD 20993–0002, 301–796–9001, FAX:
301–847–8533, email: AAC@
fda.hhs.gov, or FDA Advisory
Committee Information Line, 1–800–
741–8138 (301–443–0572 in the
Washington, DC area). A notice in the
Federal Register about last minute
modifications that impact a previously
announced advisory committee meeting
cannot always be published quickly
enough to provide timely notice.
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Therefore, you should always check the
Agency’s Web site at https://
www.fda.gov/AdvisoryCommittees/
default.htm and scroll down to the
appropriate advisory committee meeting
link, or call the advisory committee
information line to learn about possible
modifications before coming to the
meeting.
Agenda: The committee will discuss
new drug application (NDA) 207988,
lesinurad oral tablets, submitted by
Ardea Biosciences, Inc., for the
treatment of hyperuricemia associated
with gout, in combination with a
xanthine oxidase inhibitor.
FDA intends to make background
material available to the public no later
than 2 business days before the meeting.
If FDA is unable to post the background
material on its Web site prior to the
meeting, the background material will
be made publicly available at the
location of the advisory committee
meeting, and the background material
will be posted on FDA’s Web site after
the meeting. Background material is
available at https://www.fda.gov/
AdvisoryCommittees/Calendar/
default.htm. Scroll down to the
appropriate advisory committee meeting
link.
Procedure: Interested persons may
present data, information, or views,
orally or in writing, on issues pending
before the committee. Written
submissions may be made to the contact
person on or before October 8, 2015.
Oral presentations from the public will
be scheduled between approximately 1
p.m. and 2 p.m. Those individuals
interested in making formal oral
presentations should notify the contact
person and submit a brief statement of
the general nature of the evidence or
arguments they wish to present, the
names and addresses of proposed
participants, and an indication of the
approximate time requested to make
their presentation on or before
September 30, 2015. Time allotted for
each presentation may be limited. If the
number of registrants requesting to
speak is greater than can be reasonably
accommodated during the scheduled
open public hearing session, FDA may
conduct a lottery to determine the
speakers for the scheduled open public
hearing session. The contact person will
notify interested persons regarding their
request to speak by October 1, 2015.
Persons attending FDA’s advisory
committee meetings are advised that the
Agency is not responsible for providing
access to electrical outlets.
FDA welcomes the attendance of the
public at its advisory committee
meetings and will make every effort to
accommodate persons with physical
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50295
disabilities or special needs. If you
require special accommodations due to
a disability, please contact Philip
Bautista at least 7 days in advance of the
meeting.
FDA is committed to the orderly
conduct of its advisory committee
meetings. Please visit our Web site at
https://www.fda.gov/
AdvisoryCommittees/
AboutAdvisoryCommittees/
ucm111462.htm for procedures on
public conduct during advisory
committee meetings.
Notice of this meeting is given under
the Federal Advisory Committee Act (5
U.S.C. app. 2).
Dated: August 12, 2015.
Jill Hartzler Warner,
Associate Commissioner for Special Medical
Programs.
[FR Doc. 2015–20398 Filed 8–18–15; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2015–N–2817]
Medical Devices; Export Certificates;
Food and Drug Administration Export
Reform and Enhancement Act of 1996;
Certification Fees
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing the
revised fees the Agency will assess for
issuing export certificates for devices.
The FDA Export Reform and
Enhancement Act of 1996 (EREA)
provides that any person who exports a
device may request FDA certify in
writing that the exported device meets
certain specified requirements. It further
provides that FDA shall issue such a
certification within 20 days of the
receipt of a request for such certification
and that FDA may charge up to $175 for
each certification that is issued within
the 20 days. Since February 2003, FDA’s
costs to process the device certificates
have increased; however, the export
certificate fee for subsequent certificates
has not changed. Because of the
increase, FDA is raising the fees for
subsequent certificates, from the current
fee of $15 to $85, and revising the
formula used to calculate the number of
original and subsequent device export
certificates issued. These changes are
necessary to ensure that the program
remains self-sustaining and to cover
FDA’s increased costs, which are
SUMMARY:
E:\FR\FM\19AUN1.SGM
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]]>Agencies
[Federal Register Volume 80, Number 160 (Wednesday, August 19, 2015)]
[Notices]
[Pages 50293-50295]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-20430]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2015-N-2458]
Center for Devices and Radiological Health Participation in
International Medical Device Regulators Forum, Regulated Product
Submission, Table of Contents Pilot Program
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration's (FDA) Center for Devices
and Radiological Health (CDRH), Offices of Device Evaluation (ODE) and
In Vitro Diagnostics and Radiation (OIR) are announcing their
participation in the International Medical Device Regulators Forum's
(IMDRF) Regulated Product Submission Table of Contents Pilot Program.
Participation in the Pilot is voluntary and open to applicants who
submit premarket approval (PMA) applications or premarket notification
(510(k)) to either ODE or OIR. The Pilot project is intended to provide
industry, IMDRF, and CDRH staff the opportunity to evaluate the Table
of Contents structure and to receive input from industry participants.
Participants will be asked to submit their submissions electronically
using IMDRF's Table of Contents (ToC) format.
DATES: The IMDRF is seeking interest for participation in the voluntary
IMDRF Regulated Product Submission, Table of Contents Pilot Program.
See section II.A. for instructions on how to submit a request to
participate. The Pilot project will accept submissions with the ToC
structure starting September 2015 through September 2016.
FOR FURTHER INFORMATION CONTACT: Jodi Hope N. Anderson, Center for
Devices and Radiological Health, Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 66, Rm. 1520, Silver Spring, MD 20993, 301-
796-9299, Jodi.Anderson@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
The IMDRF was conceived in February 2011 as a forum to discuss
future directions in medical device regulatory harmonization. It is a
voluntary group of medical device regulators from around the world who
have come together to build on the strong foundational work of the
Global Harmonization Task Force. The Forum aims to accelerate
international medical device regulatory harmonization and convergence.
The Regulated Product Submission (RPS) proposal was endorsed as a
new work item by IMDRF at its 2012 inaugural meeting in Singapore. The
Work Group, consisting of regulatory authorities from the United
States, European Union (EU), Australia, Brazil, Japan, China, and
Canada, created a comprehensive Table of Contents for Non-In Vitro
Diagnostics (nIVD) and also for IVD Marketing Authorizations, which
were formalized in August 2014.
The ToC provides a comprehensive submission structure that can be
used as a harmonized international electronic submission format while
minimizing regional divergences and indicating where regional variation
exists. This document is intended to provide guidance regarding the
location of submission elements. These documents can be found on
IMDRF's Web site (Refs. 1 and 2).
This document is intended to work together with a regional
classification matrix, a separate document created for each
participating jurisdiction. The classification matrix defines whether a
heading is required, not required, optional, conditionally required,
etc., for the given submission type. FDA's Classification Matrices can
be found on FDA's Web site (Ref. 3).
The ToC Work Group has previously conducted Pilots for both of the
ToC structures, using historical submissions. These Pilots provided
valuable feedback regarding the ToC structure and completeness;
however, there were limitations to using historical submissions and
also a limited number of samples involving submission to more than one
jurisdiction. Furthermore, there were no specific guidelines regarding
the means of building a submission in a non-standard implementation.
Additional IMDRF testing is considered necessary to both evaluate the
ToC structures using real regulatory submissions and also evaluate the
ToC structure from an industry perspective.
II. CDRH Participation in IMDRF Regulated Product Submission Table of
Contents (ToC) Implementation Pilot
FDA's participation in the IMDRF RPS ToC Implementation Pilot will
provide both local and international benefits for FDA, as it will
provide FDA feedback into decisions regarding the ToC's suitability.
CDRH is participating in the Pilot. In doing so, CDRH will receive
premarket submissions from the medical device regulated industry using
the IMDRF ToC and FDA Regional Classification Matrices. Applications
are to be real regulatory submissions--either PMAs or 510(k)
applications--that will result in regulatory decisions by CDRH. PMAs
exclude combination products and bundled submissions. The 510(k)s
exclude special, abbreviated, and third-party submissions, as well as
combination products, bundled submissions, and amendments after a final
decision. Pilot participation requires that an application submitted to
FDA also be submitted sequentially or simultaneously to at least one
additional participating IMDRF region. Currently the participating
regulating authorities are Australia (Therapeutic Goods
Administration), Brazil (ANVISA), Canada (Health Canada), China (China
Food and Drug Administration), and the European Union (Notified
Bodies).
The Pilot is described in greater detail in the IMDRF/RPS WG/N26
Informational Document ``IMDRF Table of Contents (ToC) Pilot Plan''
(Ref. 4).
The Regulators participating in this Pilot intend to use
submissions only for the requested regulatory activity and objectives
of this Pilot. Any submissions generated in relation to this testing
will not be distributed to other manufacturers or other regulators.
Industry participants should share any submission content directly with
the appropriate regulators through the official regulatory processes in
place--i.e., submission content will be shared across regulators
directly by regulated industry.
Feedback provided on the ToC structure, experience developing
regulatory submissions, or suggestions
[[Page 50294]]
for additional ToC headings may be shared and made public, excluding
any confidential content. Basic applicant and submission identifying
information (e.g., Applicant/Correspondent/Manufacturer Name, Device
Name, Device Type, and Submission Type) will be shared among IMDRF
Regulators for the purpose of conducting the Pilot. The invitation to
participants will provide the specific details of the information to be
shared among the Regulators as it is a condition for Pilot
participation. Any information provided in the resulting Pilot findings
should only disclose information explicitly stated as releasable.
This Pilot will be evaluated in accordance with current FDA
protocols and performance standards. Feedback from reviewers will be
provided on the reviewability of the submission, based on the IMDRF ToC
and FDA classification matrix, and any observations regarding issues in
the submission content elements of the ToC Pilot. Feedback from
industry will be accepted throughout the submission building process.
The Pilot project is intended to provide industry, IMDRF, and CDRH
staff the opportunity to evaluate the ToC structure, through the
receipt of input from industry participants and CDRH staff. Comments
received during the Pilot project will be used to evaluate the
usability of the ToC format. FDA will be reviewing the contents of each
submission as part of this Pilot; however, Pilot participation for the
manufacturer will end after successfully passing the refuse to accept
criteria. Subsequently, a complete scientific review, outside of the
scope of the Pilot, will commence.
A. Participation
Volunteers interested in participating in the Pilot project should
provide expressions of interest to the IMDRF ToC working group at the
IMDRF ToC email account imdrftoc@gmail.com. Confirmation of your
interest in participation in the IMDRF ToC Pilot plan is requested. If
notification is received by August 21, 2015, then the manufacturer will
be invited to participate in a ``participation teleconference'' to
answer remaining questions. After August 21, 2015, contact FDA Pilot
staff by email at Jodi.Anderson@fda.hhs.gov with any questions. The
following information should be included in the request: Applicant,
trade name, primary product code, submission type, contact name, and
contact email. FDA will contact interested applicants to discuss the
Pilot project. FDA is seeking a limited number of participants (no more
than nine) to participate in this Pilot project. Participants must
adhere to FDA's submission requirements (i.e., eCopy) and Refuse to
Accept (RTA) requirements (Refs. 5 and 6).
B. Procedures
After reading the ToC Pilot Plan document, applicants use either
the nIVD or IVD ToC documents, as well as the respective Classification
Matrix to construct their submission. The submission, placed into a
single .zip file with the name ``MISC FILES.zip'' is then loaded onto
media via eCopy (e.g., CD, DVD, SD card, USB drive). No paper copy of
the submission is needed. All submissions are still expected to comply
with the respective PMA or 510(k) RTA guidance documents. All
submissions are still expected to comply with the FDA's eCopy Program
for Medical Device Submissions Final Guidance (Ref. 5), except for the
following: (1) With the exception of the cover letter, all sections
discussing paper copy requirements may be disregarded; (2) sections
outside the scope of the Pilot (e.g., sections pertaining to Bundled
Submissions) may be disregarded; and (3) Attachment A, Part B of the
eCopy Guidance is superseded by the ToC document. Applicants are
required to provide a paper cover letter, meeting the technical
guidance provided in the eCopy Guidance Document, Attachment 1, Part A.
In addition, the following statement must be included in bold:
This submission is part of the IMDRF ToC Pilot, and is organized
according to the IMDRF ToC. Accordingly, special eCopy processing
applies. As per the agreement for this ToC Pilot, no full paper copies
are required, and the specially-formatted submission is zipped and
placed within a MISC FILES folder in the eCopy.
The cover letter and media should be sent via mail to the Document
Control Center (DCC) to: Food and Drug Administration, Center for
Devices and Radiological Health, Document Control Center, Bldg. 66, Rm.
G609, 10903 New Hampshire Ave., Silver Spring, MD 20993-0002 ATTN:
IMDRF ToC Pilot Submission.
During the Pilot, CDRH staff will be available to answer any
questions or concerns that may arise. Pilot project participants will
be asked to comment on and discuss their experiences with the Pilot
submissions process. Their input and discussions will assist both IMDRF
and CDRH in their use of the ToC in future electronic submission
formats.
III. Duration of the IMDRF Regulated Product Submission ToC
Implementation Pilot
FDA intends to accept requests for participation in the IMDRF's
Regulated Product Submission, ToC Implementation Pilot for 12 months,
from September 2015 through September 2016. This Pilot program may be
extended as resources and needs allow.
IV. Paperwork Reduction Act of 1995
This notice refers to previously 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.FDAC. 3501-3520). The
collections of information in 21 CFR part 807, subpart E have been
approved under OMB control number 0910-0120 and the collections of
information in 21 CFR part 814, subparts A through E have been approved
under OMB control number 0910-0231.
V. References
The following references have been placed on display in the
Division of Dockets Management (HFA-305), Food and Drug Administration,
5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, and may be seen by
interested persons between 9 a.m. and 4 p.m., Monday through Friday,
and are available electronically at https://www.regulations.gov. (FDA
has verified all the Web site addresses in this reference section, but
we are not responsible for any subsequent changes to the Web sites
after this document publishes in the Federal Register.)
1. IMDRF Non-In Vitro Diagnostic Device Market Authorization Table
of Contents (nIVD MA ToC) Final Document, https://www.imdrf.org/docs/imdrf/final/technical/imdrf-tech-140630-rps-nivd-toc.pdf.
2. IMDRF In Vitro Diagnostic Device Market Authorization Table of
Contents (IVD MA ToC) Final Document, https://www.imdrf.org/docs/imdrf/final/technical/imdrf-tech-140630-rps-ivd-toc.pdf.
3. FDA/IMDRF Documents, Regulated Product Submission (RPS) Work
Item, https://www.fda.gov/MedicalDevices/InternationalPrograms/IMDRF/ucm417027.htm.
4. IMDRF Table of Contents (ToC) Pilot Plan, https://www.imdrf.org/docs/imdrf/final/procedural/imdrf-proc-150708-toc-pilot-plan.pdf.
5. FDA's eCopy Program for Medical Device Submissions Final
Guidance, October 10, 2013, https://www.fda.gov/downloads/
MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/
[[Page 50295]]
UCM313794.pdf.
6. FDA's Refuse to Accept Policy for 510(k)s Final Guidance,
December 31, 2012, https://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM315014.pdf.
Dated: August 13, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-20430 Filed 8-18-15; 8:45 am]
BILLING CODE 4164-01-P
