Food and Drug Administration Decisions for Investigational Device Exemption Clinical Investigations; Draft Guidance for Industry and Food and Drug Administration Staff; Availability, 35937-35939 [2013-14137]
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Federal Register / Vol. 78, No. 115 / Friday, June 14, 2013 / Notices
recommendations must be submitted in
any one of the following ways:
1. Electronically. You may send your
comments electronically to https://
www.regulations.gov. Follow the
instructions for ‘‘Comment or
Submission’’ or ‘‘More Search Options’’
to find the information collection
document(s) that are accepting
comments.
2. By regular mail. You may mail
written comments to the following
address: CMS, Office of Strategic
Operations and Regulatory Affairs,
Division of Regulations Development,
Attention: Document Identifier/OMB
Control Numberlll, Room C4–26–
05, 7500 Security Boulevard, Baltimore,
Maryland 21244–1850.
To obtain copies of a supporting
statement and any related forms for the
proposed collection(s) summarized in
this notice, you may make your request
using one of following:
1. Access CMS’ Web site address at
https://www.cms.hhs.gov/
PaperworkReductionActof1995.
2. Email your request, including your
address, phone number, OMB number,
and CMS document identifier, to
Paperwork@cms.hhs.gov.
3. Call the Reports Clearance Office at
(410) 786–1326.
FOR FURTHER INFORMATION CONTACT: Call
the Reports Clearance Office at (410)
786–1326.
SUPPLEMENTARY INFORMATION:
This notice sets out a summary of the
use and burden associated with the
following information collections. More
detailed information can be found in
each collection’s supporting statement
and associated materials (see
ADDRESSES).
mstockstill on DSK4VPTVN1PROD with NOTICES
CMS–10482 Evaluation of the
Physician Quality Reporting System
(PQRS) and Electronic Prescribing
(eRx) Incentive Program
Under the Paperwork Reduction Act
of 1995 (PRA) (44 U.S.C. 3501–3520),
federal agencies must obtain approval
from the Office of Management and
Budget (OMB) for each collection of
information they conduct or sponsor.
The term ‘‘collection of information’’ is
defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes agency requests
or requirements that members of the
public submit reports, keep records, or
provide information to a third party.
Section 3506(c)(2)(A) of the PRA
requires federal agencies to publish a
60-day notice in the Federal Register
concerning each proposed collection of
information, including each proposed
extension or reinstatement of an existing
collection of information, before
VerDate Mar<15>2010
17:03 Jun 13, 2013
Jkt 229001
submitting the collection to OMB for
approval. To comply with this
requirement, CMS is publishing this
notice.
Information Collection
1. Type of Information Collection
Request: New Collection (Request for a
new OMB control number); Title of
Information Collection: Evaluation of
the Physician Quality Reporting System
(PQRS) and Electronic Prescribing (eRx)
Incentive Program; Use: The Physician
Quality Reporting System (PQRS) was
first implemented in 2007 as an
incentive for voluntary reporting of
quality measures in accordance with a
section of the Tax Relief and Health
Care Act of 2006. The PQRS was further
extended and enhanced by legislation
such as the Medicare, Medicaid, and
State Children’s Health Insurance
Program (SCHIP) Extension Act of 2007
(MMSEA) and the Medicare
Improvements for Patients and
Providers Act of 2008 (MIPPA). A
number of changes have been made to
the PQRS, including group measures,
the group reporting option, and
additional measures. The PQRS was
extended further with the enactment of
MMSEA. The MMSEA provided
professionals greater flexibility for
participating in the PQRS for 2008 and
2009 by authorizing us to establish
alternative reporting criteria and
alternative reporting periods for the
reporting measures groups and for the
submission of data on the PQRS quality
measures through clinical data
registries. The MIPPA, enacted in July
2008, made the PQRS program
permanent, further enhanced the PQRS,
and established a new standalone
incentive program for successful
electronic prescribers.
The eRx Incentive Program, the other
program being evaluated in this project,
was first implemented in 2009. The eRx
is another incentive reporting program
that uses a combination of incentive
payments and payment adjustments to
encourage eRx by eligible professionals.
The program provides an incentive
payment to practices with eligible
professionals who successfully eprescribe for covered Physician Fee
Schedule services furnished to Medicare
Part B Fee-For-Service (FFS)
beneficiaries. Eligible professionals do
not need to participate in PQRS to
participate in the eRx Incentive
Program.
In support of an evaluation the PQRS
and the eRx Incentive Program, we will
conduct three surveys. The surveys will
include: Medicare beneficiaries, eligible
professionals, and administrators. This
evaluation is designed to determine how
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35937
well the PQRS and the eRx Incentive
Program are contributing to better and
affordable health care for Medicare
beneficiaries. The PQRS is a voluntary
reporting program that provides an
incentive payment to eligible
professionals who satisfactorily report
data on quality measures. We use
quality measures to promote
improvements in care delivery and
payment and to increase transparency.
The PQRS program rewards eligible
professionals based on a percentage of
the estimated Medicare Physician Fee
Schedule of their allowed Part B charges
if they meet the defined reporting
requirements. The PQRS was initially
referred to as the Physician Quality
Reporting Initiative (PQRI). Form
Number: CMS–10482 (OCN: 0938–
NEW); Frequency: Yearly; Affected
Public: Individuals and households,
Business or other for-profit, Not-forprofit institutions; Number of
Respondents: 6,350; Total Annual
Responses: 6,350; Total Annual Hours:
2,545. (For policy questions regarding
this collection contact Lauren Fuentes at
410–786–2290. For all other issues call
410–786–1326.)
Dated: June 11, 2013.
Martique Jones,
Deputy Director, Regulations Development
Group, Office of Strategic Operations and
Regulatory Affairs.
[FR Doc. 2013–14174 Filed 6–13–13; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2011–D–0790]
Food and Drug Administration
Decisions for Investigational Device
Exemption Clinical Investigations;
Draft Guidance for Industry and Food
and Drug Administration Staff;
Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing the
availability of the draft guidance
entitled ‘‘FDA Decisions for
Investigational Device Exemption (IDE)
Clinical Investigations.’’ This guidance
document was initially issued in draft
on November 10, 2011, and was
developed to promote the initiation of
clinical investigations to evaluate
medical devices under FDA’s IDE
regulations. The guidance was also
intended to provide clarification
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35938
Federal Register / Vol. 78, No. 115 / Friday, June 14, 2013 / Notices
regarding the regulatory implications of
the decisions that FDA may render
based on review of an IDE and to
provide a general explanation of the
reasons for those decisions. This
guidance has been revised and is being
reissued for comment because the Food
and Drug Administration Safety and
Innovation Act (FDASIA), which
became law on July 9, 2012, amended
the Federal Food, Drug, and Cosmetic
Act (the FD&C Act) to specify certain
situations in which FDA cannot
disapprove an IDE. This draft guidance
is not final nor is it in effect at this time.
DATES: Although you can comment on
any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the Agency
considers your comment on this draft
guidance before it begins work on the
final version of the guidance, submit
either electronic or written comments
on the draft guidance by September 12,
2013.
ADDRESSES: Submit written requests for
single copies of the draft guidance
document entitled ‘‘FDA Decisions for
Investigational Device Exemption (IDE)
Clinical Investigations’’ to the Division
of Small Manufacturers, International,
and Consumer Assistance, Center for
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
(CBER), Food and Drug Administration,
1401 Rockville Pike, suite 200N,
Rockville, MD 20852–1448. Send one
self-addressed 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:
Owen Faris, Center for Devices and
Radiological Health, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 1108, Silver Spring,
MD 20993–0002, 301–796–6356; or
Stephen Ripley, Center for Biologics
Evaluation and Research, Food and
Drug Administration, 1401 Rockville
Pike, suite 200N, Rockville, MD 20852,
301–827–6210.
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17:03 Jun 13, 2013
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SUPPLEMENTARY INFORMATION:
I. Background
FDA approval of an IDE submission
allows the initiation of a clinical
investigation of a significant risk device.
This guidance is intended to provide
clarification regarding the regulatory
implications of the decisions that FDA
may render based on review of an IDE
and to provide a general explanation of
the reasons for those decisions. In an
effort to promote timely initiation of
enrollment in clinical investigations in
a manner that protects study subjects,
FDA has developed methods to allow a
clinical investigation of a device to
begin under certain circumstances, even
when there are outstanding issues
regarding the IDE submission. These
mechanisms, including approval with
conditions, staged approval, and
communication of outstanding issues
related to the IDE through study design
considerations and future
considerations, are described in this
guidance.
FDA has traditionally referred to IDE
approvals that have conditions as
‘‘conditional approvals.’’ FDA believes
that the term ‘‘approval with
conditions’’ is more appropriate because
the term conveys that the IDE has been
approved and the study may begin
without awaiting further FDA review.
An IDE may be approved with
conditions if FDA has determined that,
despite outstanding issues, the
information provided is sufficient to
justify human clinical evaluation of the
device and the proposed study design is
acceptable with regard to protection of
study subjects.
FDA may now also communicate
‘‘future considerations’’, which are
issues and recommendations that FDA
believes the sponsor should consider in
preparation for a marketing application
or a future clinical investigation. Future
considerations are intended to provide
helpful, non-binding advice to sponsors
regarding important elements of the
future application that the IDE may not
specifically address. FDA is considering
whether future considerations should be
communicated in our IDE decision
letters or whether they should be sent to
the sponsor in a separate
communication. The Agency is
specifically seeking comment on this
issue.
Consistent with the November 2011
draft guidance, this guidance also
proposes two other mechanisms for
approving studies or approving studies
with conditions: ‘‘Staged approval’’ and
‘‘staged approval with conditions,’’ by
which FDA may grant IDE approval or
approval with conditions, while certain
PO 00000
Frm 00091
Fmt 4703
Sfmt 4703
outstanding questions are answered
concurrent with enrollment of a limited
number of subjects in the clinical
investigation. Staged approval and
staged approval with conditions permit
the clinical investigation to begin in a
timely manner while maintaining
appropriate subject protections. Staged
approval or staged approval with
conditions is most common for pivotal
studies in which many subjects will be
enrolled over an extended period of
time, but may be applicable to other
clinical investigations as well.
Section 601 of FDASIA amended
section 520(g) of the FD&C Act (21
U.S.C. 360j(g)) to specify certain
situations in which FDA cannot
disapprove an IDE. Section 520(g)(4)(C)
of the FD&C Act states that, consistent
with section 520(g)(1), FDA shall not
disapprove an IDE because: (1) The
investigation may not support a
substantial equivalence or de novo
classification determination or approval
of the device; (2) the investigation may
not meet a requirement, including a data
requirement, relating to the approval or
clearance of a device; or (3) an
additional or different investigation may
be necessary to support clearance or
approval of the device. The draft
guidance has been revised in light of
this new provision and to introduce the
communication to the sponsor of study
design-related issues. If FDA believes
that additional modifications to the
study design are needed, which are
unrelated to subject safety, for the study
design to be adequate and ultimately
support a marketing application, if that
is the intent of the sponsor, these
suggested modifications will be noted in
the ‘‘study design considerations’’
section of FDA’s letter. Sponsors are not
required to modify the investigational
plan to address study design
considerations. However, if these
considerations are not addressed, the
study design may not support the study
goals (e.g., a future marketing
application). FDA is considering
whether study design considerations
should be communicated in our IDE
decision letters or whether they should
be sent to the sponsor in a separate
communication. The Agency is
specifically seeking comment on this
issue.
Section 601 of FDASIA specifies
certain situations in which FDA cannot
disapprove an IDE. However, the
Agency recognizes that some IDE
sponsors may wish to determine
whether the pivotal study design may
support a marketing application if it is
successfully executed and meets its
stated endpoints without raising
unforeseen safety concerns. To meet this
E:\FR\FM\14JNN1.SGM
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Federal Register / Vol. 78, No. 115 / Friday, June 14, 2013 / Notices
interest, FDA is proposing a new,
voluntary program intended to
encourage device manufacturers to
engage with the Agency in the
development of trial designs that may
support a marketing approval or
clearance. The Agency recognizes that
this type of voluntary program will not
likely be suitable for all IDE sponsors
and does not intend that this program
become a routine step prior to
submission of an IDE. This program is
not intended to replace or be a
substitute for the Pre-Submission
process (Refer to the draft guidance
entitled ‘‘Medical Devices: The PreSubmission Program and Meetings with
FDA Staff’’ (https://www.fda.gov/
MedicalDevices/
DeviceRegulationandGuidance/
GuidanceDocuments/ucm310375.htm,
which, when finalized, will represent
FDA’s current thinking on this topic).
This program, referred to as the ‘‘PreDecisional IDE Process,’’ is a voluntary
approach to enable sponsors to obtain
timely feedback from review staff on a
near-final IDE application, with the
opportunity for a midcycle interaction
with the review team to promote clearer
understanding and quicker resolution of
major issues with device or subject
safety as well as study design. The PreDecisional IDE process is different from
the Pre-Submission process, which is
appropriate for focused discussions
with FDA early in device development
or when nonclinical testing is
underway. Pre-Submission discussions
are generally limited in nature, as they
focus on the proposed protocol and the
specific questions for which the sponsor
is requesting FDA feedback.
Additionally, FDA does not typically
review data from nonclinical bench,
animal, or other studies when providing
feedback on a clinical study protocol as
part of a Pre-Submission. In contrast,
Pre-Decisional IDEs will include data
and full study protocols and reports
where appropriate, and will be reviewed
in a similar manner as an IDE, allowing
for more complete and meaningful
feedback from review staff. FDA intends
to adhere to the feedback and decisions
reached during the Pre-Decisional IDE
review. FDA intends that modifications
to our feedback will be limited to
situations in which FDA concludes that
the feedback given previously does not
adequately address important issues
materially relevant to a determination of
safety or effectiveness that have been
identified since the time of the PreDecisional IDE. In such cases, FDA
should acknowledge a change in our
advice, document the rationale for the
change, and support the determination
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with appropriate management
concurrence.
Although this process, as proposed,
would occur over a 65-day timeframe
(from submission of the Pre-Decisional
IDE to complete FDA feedback,
inclusive of the midcycle interaction),
FDA believes that this process could
result in faster approval without
conditions of IDE submissions with
study designs that are sufficiently robust
to support market approval or clearance.
Currently, many IDE submissions are
approved with conditions only after an
initial disapproval and submission of
one or more responses, and may remain
approved with conditions over many
months while the outstanding issues are
addressed. The Pre-Decisional IDE
process is intended to reach an
unconditional approval more quickly,
and will help to address several
commonly reported challenges in the
initiation of clinical trials, such as
delays in institutional review board
approvals and reimbursement from
third-party payers. In addition to
seeking comments on the revised draft
guidance as a whole, the Agency is
specifically seeking comment on this
new proposed program, as outlined in
section 10 of the guidance.
As a result of this draft guidance,
FDA, where appropriate, seeks to offer
flexibility in how outstanding issues can
be addressed to allow clinical
investigations to commence without
unnecessary delay, while ensuring that
human subjects are adequately
protected.
FDA issued this guidance document
as draft on November 10, 2011. The
Agency has considered the comments
received during the comment period
and incorporated modifications, as
appropriate. This guidance has also
been revised to reflect the changes to the
FD&C Act described in this document
and is being reissued in draft in order
to solicit comment on these significant
revisions.
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 FDA decisions for IDE clinical
investigations. 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.
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Frm 00092
Fmt 4703
Sfmt 9990
35939
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
Center for Devices and Radiological
Health guidance documents is available
at https://www.fda.gov/MedicalDevices/
DeviceRegulationandGuidance/
GuidanceDocuments/default.htm.
Guidance documents are also available
at https://www.regulations.gov. To
receive ‘‘FDA Decisions for
Investigational Device Exemption (IDE)
Clinical Investigations,’’ 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 1783 to identify the guidance
you are requesting.
IV. Paperwork Reduction Act of 1995
This draft guidance 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.C. 3501–3520). The collections
of information in 21 CFR part 812 have
been approved under OMB control
number 0910–0078.
V. Comments
Interested persons may submit either
electronic comments regarding this
document to https://www.regulations.gov
or written comments to the Division of
Dockets Management (see ADDRESSES). 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, and
will be posted to the docket at https://
www.regulations.gov.
Dated: June 10, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013–14137 Filed 6–13–13; 8:45 am]
BILLING CODE 4160–01–P
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]]>Agencies
[Federal Register Volume 78, Number 115 (Friday, June 14, 2013)]
[Notices]
[Pages 35937-35939]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-14137]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2011-D-0790]
Food and Drug Administration Decisions for Investigational Device
Exemption Clinical Investigations; Draft Guidance for Industry and Food
and Drug Administration Staff; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of the draft guidance entitled ``FDA Decisions for
Investigational Device Exemption (IDE) Clinical Investigations.'' This
guidance document was initially issued in draft on November 10, 2011,
and was developed to promote the initiation of clinical investigations
to evaluate medical devices under FDA's IDE regulations. The guidance
was also intended to provide clarification
[[Page 35938]]
regarding the regulatory implications of the decisions that FDA may
render based on review of an IDE and to provide a general explanation
of the reasons for those decisions. This guidance has been revised and
is being reissued for comment because the Food and Drug Administration
Safety and Innovation Act (FDASIA), which became law on July 9, 2012,
amended the Federal Food, Drug, and Cosmetic Act (the FD&C Act) to
specify certain situations in which FDA cannot disapprove an IDE. This
draft guidance is not final nor is it in effect at this time.
DATES: Although you can comment on any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the Agency considers your comment on this
draft guidance before it begins work on the final version of the
guidance, submit either electronic or written comments on the draft
guidance by September 12, 2013.
ADDRESSES: Submit written requests for single copies of the draft
guidance document entitled ``FDA Decisions for Investigational Device
Exemption (IDE) Clinical Investigations'' to the Division of Small
Manufacturers, International, and Consumer Assistance, Center for
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 (CBER), Food and Drug Administration,
1401 Rockville Pike, suite 200N, Rockville, MD 20852-1448. Send one
self-addressed 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: Owen Faris, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 1108, Silver Spring, MD 20993-0002, 301-796-6356;
or Stephen Ripley, Center for Biologics Evaluation and Research, Food
and Drug Administration, 1401 Rockville Pike, suite 200N, Rockville, MD
20852, 301-827-6210.
SUPPLEMENTARY INFORMATION:
I. Background
FDA approval of an IDE submission allows the initiation of a
clinical investigation of a significant risk device. This guidance is
intended to provide clarification regarding the regulatory implications
of the decisions that FDA may render based on review of an IDE and to
provide a general explanation of the reasons for those decisions. In an
effort to promote timely initiation of enrollment in clinical
investigations in a manner that protects study subjects, FDA has
developed methods to allow a clinical investigation of a device to
begin under certain circumstances, even when there are outstanding
issues regarding the IDE submission. These mechanisms, including
approval with conditions, staged approval, and communication of
outstanding issues related to the IDE through study design
considerations and future considerations, are described in this
guidance.
FDA has traditionally referred to IDE approvals that have
conditions as ``conditional approvals.'' FDA believes that the term
``approval with conditions'' is more appropriate because the term
conveys that the IDE has been approved and the study may begin without
awaiting further FDA review. An IDE may be approved with conditions if
FDA has determined that, despite outstanding issues, the information
provided is sufficient to justify human clinical evaluation of the
device and the proposed study design is acceptable with regard to
protection of study subjects.
FDA may now also communicate ``future considerations'', which are
issues and recommendations that FDA believes the sponsor should
consider in preparation for a marketing application or a future
clinical investigation. Future considerations are intended to provide
helpful, non-binding advice to sponsors regarding important elements of
the future application that the IDE may not specifically address. FDA
is considering whether future considerations should be communicated in
our IDE decision letters or whether they should be sent to the sponsor
in a separate communication. The Agency is specifically seeking comment
on this issue.
Consistent with the November 2011 draft guidance, this guidance
also proposes two other mechanisms for approving studies or approving
studies with conditions: ``Staged approval'' and ``staged approval with
conditions,'' by which FDA may grant IDE approval or approval with
conditions, while certain outstanding questions are answered concurrent
with enrollment of a limited number of subjects in the clinical
investigation. Staged approval and staged approval with conditions
permit the clinical investigation to begin in a timely manner while
maintaining appropriate subject protections. Staged approval or staged
approval with conditions is most common for pivotal studies in which
many subjects will be enrolled over an extended period of time, but may
be applicable to other clinical investigations as well.
Section 601 of FDASIA amended section 520(g) of the FD&C Act (21
U.S.C. 360j(g)) to specify certain situations in which FDA cannot
disapprove an IDE. Section 520(g)(4)(C) of the FD&C Act states that,
consistent with section 520(g)(1), FDA shall not disapprove an IDE
because: (1) The investigation may not support a substantial
equivalence or de novo classification determination or approval of the
device; (2) the investigation may not meet a requirement, including a
data requirement, relating to the approval or clearance of a device; or
(3) an additional or different investigation may be necessary to
support clearance or approval of the device. The draft guidance has
been revised in light of this new provision and to introduce the
communication to the sponsor of study design-related issues. If FDA
believes that additional modifications to the study design are needed,
which are unrelated to subject safety, for the study design to be
adequate and ultimately support a marketing application, if that is the
intent of the sponsor, these suggested modifications will be noted in
the ``study design considerations'' section of FDA's letter. Sponsors
are not required to modify the investigational plan to address study
design considerations. However, if these considerations are not
addressed, the study design may not support the study goals (e.g., a
future marketing application). FDA is considering whether study design
considerations should be communicated in our IDE decision letters or
whether they should be sent to the sponsor in a separate communication.
The Agency is specifically seeking comment on this issue.
Section 601 of FDASIA specifies certain situations in which FDA
cannot disapprove an IDE. However, the Agency recognizes that some IDE
sponsors may wish to determine whether the pivotal study design may
support a marketing application if it is successfully executed and
meets its stated endpoints without raising unforeseen safety concerns.
To meet this
[[Page 35939]]
interest, FDA is proposing a new, voluntary program intended to
encourage device manufacturers to engage with the Agency in the
development of trial designs that may support a marketing approval or
clearance. The Agency recognizes that this type of voluntary program
will not likely be suitable for all IDE sponsors and does not intend
that this program become a routine step prior to submission of an IDE.
This program is not intended to replace or be a substitute for the Pre-
Submission process (Refer to the draft guidance entitled ``Medical
Devices: The Pre-Submission Program and Meetings with FDA Staff''
(https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm310375.htm, which, when finalized, will represent
FDA's current thinking on this topic).
This program, referred to as the ``Pre-Decisional IDE Process,'' is
a voluntary approach to enable sponsors to obtain timely feedback from
review staff on a near-final IDE application, with the opportunity for
a midcycle interaction with the review team to promote clearer
understanding and quicker resolution of major issues with device or
subject safety as well as study design. The Pre-Decisional IDE process
is different from the Pre-Submission process, which is appropriate for
focused discussions with FDA early in device development or when
nonclinical testing is underway. Pre-Submission discussions are
generally limited in nature, as they focus on the proposed protocol and
the specific questions for which the sponsor is requesting FDA
feedback. Additionally, FDA does not typically review data from
nonclinical bench, animal, or other studies when providing feedback on
a clinical study protocol as part of a Pre-Submission. In contrast,
Pre-Decisional IDEs will include data and full study protocols and
reports where appropriate, and will be reviewed in a similar manner as
an IDE, allowing for more complete and meaningful feedback from review
staff. FDA intends to adhere to the feedback and decisions reached
during the Pre-Decisional IDE review. FDA intends that modifications to
our feedback will be limited to situations in which FDA concludes that
the feedback given previously does not adequately address important
issues materially relevant to a determination of safety or
effectiveness that have been identified since the time of the Pre-
Decisional IDE. In such cases, FDA should acknowledge a change in our
advice, document the rationale for the change, and support the
determination with appropriate management concurrence.
Although this process, as proposed, would occur over a 65-day
timeframe (from submission of the Pre-Decisional IDE to complete FDA
feedback, inclusive of the midcycle interaction), FDA believes that
this process could result in faster approval without conditions of IDE
submissions with study designs that are sufficiently robust to support
market approval or clearance. Currently, many IDE submissions are
approved with conditions only after an initial disapproval and
submission of one or more responses, and may remain approved with
conditions over many months while the outstanding issues are addressed.
The Pre-Decisional IDE process is intended to reach an unconditional
approval more quickly, and will help to address several commonly
reported challenges in the initiation of clinical trials, such as
delays in institutional review board approvals and reimbursement from
third-party payers. In addition to seeking comments on the revised
draft guidance as a whole, the Agency is specifically seeking comment
on this new proposed program, as outlined in section 10 of the
guidance.
As a result of this draft guidance, FDA, where appropriate, seeks
to offer flexibility in how outstanding issues can be addressed to
allow clinical investigations to commence without unnecessary delay,
while ensuring that human subjects are adequately protected.
FDA issued this guidance document as draft on November 10, 2011.
The Agency has considered the comments received during the comment
period and incorporated modifications, as appropriate. This guidance
has also been revised to reflect the changes to the FD&C Act described
in this document and is being reissued in draft in order to solicit
comment on these significant revisions.
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 FDA
decisions for IDE clinical investigations. 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 Center for
Devices and Radiological Health guidance documents is available at
https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm. Guidance documents are also available at
https://www.regulations.gov. To receive ``FDA Decisions for
Investigational Device Exemption (IDE) Clinical Investigations,'' 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 1783 to identify
the guidance you are requesting.
IV. Paperwork Reduction Act of 1995
This draft guidance 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.C. 3501-3520). The
collections of information in 21 CFR part 812 have been approved under
OMB control number 0910-0078.
V. Comments
Interested persons may submit either electronic comments regarding
this document to https://www.regulations.gov or written comments to the
Division of Dockets Management (see ADDRESSES). 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, and will be posted to the docket at https://www.regulations.gov.
Dated: June 10, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-14137 Filed 6-13-13; 8:45 am]
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