[Federal Register Volume 76, Number 196 (Tuesday, October 11, 2011)]
[Notices]
[Pages 62808-62810]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-25907]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare and Medicaid Services
[CMS-3180-N2]
Food and Drug Administration
[Docket No. FDA-2010-N-0308]
Pilot Program for Parallel Review of Medical Products
AGENCY: Food and Drug Administration, Centers for Medicare and Medicaid
Services, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) and the Centers for
Medicare and Medicaid Services (CMS) (the Agencies) are soliciting
nominations from sponsors of innovative device technologies to
participate in a pilot program for concurrent review of certain FDA
premarket review submissions and CMS national coverage determinations.
The Agencies announced the intention to initiate a pilot program in the
Federal Register of September 17, 2010. The Agencies are now providing
notice of the procedures for voluntary participation in the pilot
program, as well as the guiding principles the Agencies intend to
follow.
DATES: Effective Date: November 10, 2011.
FOR FURTHER INFORMATION CONTACT:
For device sponsors interested in requesting voluntary parallel
review:
Markham C. Luke, Center for Devices and Radiological Health, Food and
Drug Administration, 301-796-5550, e-mail: [email protected].
For General questions about parallel review:
Peter Beckerman, Office of Policy, Food and Drug Administration, 301-
796-4830, e-mail: [email protected] or
Tamara Syrek Jensen, Centers for Medicare and Medicaid Services, 410-
786-3529, e-mail: [email protected].
SUPPLEMENTARY INFORMATION:
I. Background
A. Parallel Review Proposal
As discussed in the September 17, 2010, Federal Register notice (75
FR 57045), parallel review is intended to reduce the time between FDA
marketing approval and CMS national coverage determinations, thereby
improving the quality of patient health care by facilitating earlier
access to innovative medical products for Medicare beneficiaries. In
the notice of September 17, 2010, we solicited comments on parallel
review of submissions to FDA and CMS for regulated medical products. We
also stated our intention to initiate a pilot program for parallel
review of devices. The Agencies received 36 comments before the comment
period closed on December 16, 2010. The public comments can be found
at: http://www.regulations.gov, identified by docket number FDA-2010-N-
0308. Major themes of the comments included, among others: Parallel
review should be sponsor/requester initiated, voluntary, and include an
option to opt out of a national coverage determination (NCD); agencies
should clarify the confidentiality standards for data sharing between
the Agencies; and agencies should establish clear and concise
guidelines on the procedures and a timeline for parallel review. These
comments have informed the parallel review pilot program for medical
devices we are announcing in this notice. We also intend to seek input
and feedback from candidate sponsor/requesters who participate in the
pilot. Current information describing the FDA-CMS Parallel Review Pilot
Program for Medical Devices can be found at the following Web site:
http://www.parallel-review.fda.gov.
B. Expected Benefits of Parallel Review
The expected benefits of an FDA-CMS parallel review program were
discussed in the September 17, 2010, notice. The anticipated benefits
include facilitating development of innovative new products and
increased efficiency in the Agencies' review processes.
It has come to our attention that innovators have generally focused
solely on obtaining FDA approval, only to later realize that Medicare
payment may not automatically be forthcoming.
As stated in the notice of September 17, 2010, parallel review will
serve the
[[Page 62809]]
public interest by providing the possibility of reducing the time
between FDA marketing approval or clearance decisions and Medicare
NCDs. The efficiencies gained by parallel review are expected to
benefit all interested parties. Patients are expected to gain quicker
access to innovative medical technologies if they are covered. The
sponsor/requester gains timely insight to the information needs of CMS
with respect to pursuing a positive NCD as well as a potentially
shortened time to payment due to a streamlined multi-review process.
The Agencies gain enhanced channels of communication. Specifically with
regard to CMS, its early involvement will streamline the decision
making process. It will also focus attention on health outcomes of
importance to Medicare, and provide early awareness of any remaining
evidence gaps. If there are evidence gaps, CMS may address them by
implementing coverage with evidence development (CED) or other policy
vehicles. For example, if FDA approval or clearance is conditioned on a
post-approval study, CMS could decide to cover the device within the
parameters of the post-approval study under CED.
II. Parallel Review Pilot Program for Medical Devices
The Agencies have developed a pilot program that reflects our
review of the comments received on the September 17, 2010, notice and
our interest in creating a streamlined process with minimal additional
burden to interested sponsor/requesters. This document outlines the:
(1) Guiding principles underlying the pilot program; (2) appropriate
candidates for the pilot program; (3) procedures FDA and CMS intend to
follow in conducting parallel product reviews; and (4) general roles
and responsibilities of the sponsor/requester, FDA, and CMS.
A. Guiding Principles
In response to comments received, the Agencies have identified
basic principles underlying the parallel review pilot program described
in this document. The following principles are intended to create a
common understanding among the sponsor/requester, FDA, and CMS about
the goals and parameters of the parallel review pilot program:
1. Participation in parallel review will not affect the review
standard for device approval by FDA or for a coverage determination by
CMS.
2. The Agencies will adhere to all statutory and regulatory
requirements as stipulated in the memorandum of understanding between
FDA and CMS, available at http://www.fda.gov/aboutfda/partnershipscollaborations/memorandaofunderstandingmous/domesticmous/ucm217585.htm.
3. A sponsor/requester may withdraw from, and FDA and CMS may
terminate, parallel review up until the time of CMS's public posting of
an NCD tracking sheet.
4. The Agencies will not publicly disclose participation of a
sponsor/requester in parallel review prior to CMS's posting of an NCD
tracking sheet, unless the sponsor/requester consents or has already
made this information public or disclosure is required by law. If a
sponsor/requester does not wish the information that would be revealed
by the posting of the NCD tracking sheet to become public, it must
withdraw from parallel review prior to this point.
5. Due to Agency resource issues the pilot program expects to
accept no more than three to five candidates per year.
B. Appropriate Candidates
During its pilot phase, the Agencies believe parallel review should
focus on truly innovative technologies that are most likely to benefit
from the efficiencies of parallel review. Accordingly, appropriate
candidates for the parallel review pilot are medical devices which each
use the following:
1. New technologies for which the sponsor/requester has had
sufficient pre-investigational device exemption (IDE) interaction with
FDA or approved IDE application.
2. New technologies for which an original or supplemental
application for premarket approval (PMA) or petition for de novo review
would be required.
3. New technologies that fall within the scope of a Part A or Part
B Medicare benefit category and are not subject to an NCD.
The agencies encourage any interested sponsors who believe their
devices are appropriate candidates and would like to explore the use of
the pilot program to contact FDA by e-mail at: [email protected],
before initiating the procedures referenced under section II.C of this
document entitled ``C. Procedures.''
C. Procedures
For sponsor/requesters of devices that have already had contact
with FDA through the pre-IDE or IDE process, much of the information
necessary to assess the suitability of a candidate technology should
already be in FDA's possession. The Agencies have developed the
following procedures to ensure adequate information to assess a
candidate's suitability for parallel review without creating a
burdensome new application process:
1. Nomination. The sponsor/requester of an innovative therapeutic
or diagnostic device may nominate its device for participation in
parallel review by following the instructions posted on the http://www.parallel-review.fda.gov web page. FDA intends to acknowledge
receipt of nominations by e-mail. The following information will assist
FDA in processing and responding to nominations:
Name of the sponsor/requester and relevant contact
information;
Pre-IDE/IDE/PMA/De Novo reference number;
Name of the product;
Succinct description of the technology and disease or
condition the device is intended to diagnose or treat;
Stage of development of the technology (that is, in
preclinical testing, in clinical trials, currently undergoing premarket
review by FDA);
Brief statement explaining why the device is an
appropriate candidate for the pilot program as described under the
section II.B of this document entitled: ``B. Appropriate Candidates.''
2. FDA/CMS Consideration. The Agencies intend to meet to consider a
nomination within 30 days of receiving a complete nomination containing
the information described previously. The Agencies may contact the
sponsor/requester to request supplemental information.
3. Sponsor/requester Notification. Upon completion of the
consideration meeting, the Agencies will notify the sponsor/requester
whether the product is an appropriate candidate for the parallel review
pilot program.
4. Acceptance Meeting. If deemed an appropriate candidate, the
Agencies will meet with the product sponsor/requester, either in person
or by phone.
5. FDA Review. Parallel review candidates will be reviewed
according the normal FDA review process. Participation in parallel
review will not affect user fees, review timeframes or procedures, or
the FDA standard of approval, which is reasonable assurance of safety
and effectiveness.
6. CMS NCD Review and Timing. CMS will begin its informal review
process sometime after submission of the PMA or de novo petition. For
PMAs, this will typically begin after the PMA-specific Panel meeting of
the FDA Medical Devices Advisory Committee.
D. Roles and Responsibilities
The Agencies have outlined the general roles and responsibilities
of each participant in the parallel review process to ensure clarity
and shared
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understandings. These roles and responsibilities are as follows:
1. Sponsor/requester. The sponsor/requester initiates consideration
for parallel review by submitting a complete nomination as outlined
previously under ``1. Nomination,'' of section II.C of this document
entitled ``Procedures.''. Once a nomination has been submitted, the
sponsor/requester should comply with all requirements necessary for FDA
review of a PMA or de novo petition and CMS issuance of an NCD
including the submission of a formal request for an NCD. The Agencies
request that a sponsor/requester who wishes to withdraw from the
parallel review process notify the FDA and CMS in writing before CMS'
formal opening of an NCD by the posting of the NCD tracking sheet.
2. The FDA. FDA will provide a secure and confidential nomination
and review process as outlined previously in section II.C of this
document. FDA will initiate review of nominations for parallel review
by retrieving applications from the secure mailbox, and coordinating
with CMS, on the planning and implementation of the parallel review
process. FDA will review PMAs and de novo petitions for products that
have been selected by the Agencies for parallel review according to the
usual timeframes, procedures, and review standards for PMA approval and
de novo classification.
3. The CMS. In addition to the coverage review, CMS's parallel
review roles include participating in the nomination process as well as
coordinating with FDA regarding the planning and implementation of the
parallel review process. During the parallel review, CMS is responsible
for maintaining open communication channels with FDA and the sponsor/
requester and for fulfilling its statutory obligations concerning the
NCD process.
E. Duration of the Pilot
The Agencies intend to accept requests for participation in the
pilot program for parallel review for 2 years. The Agencies may
terminate the pilot program before the close of the 2-year period, or
may extend the pilot program beyond 2 years. The decisions will be
announced in the Federal Register.
F. Evaluation
The Agencies intend to use their experience with the pilot program
to develop a parallel review program not only for devices but also for
drugs and biological products. The Agencies anticipate their experience
with the parallel review program for devices and feedback from
participants in the program will inform guidance for a broader program
applicable to all medical products. The Agencies may also determine
that they should extend or modify the parallel review pilot program to
continue their evaluation.
(Catalog of Federal Domestic Assistance Program No. 93.778, Medical
Assistance Program) (Catalog of Federal Domestic Assistance Program
No. 93.773, Medicare--Hospital Insurance; and Program No. 93.774,
Medicare--Supplementary Medical Insurance Program)
Dated: September 21, 2011.
Donald M. Berwick,
Administrator, Centers for Medicare & Medicaid Services.
Dated: September 21, 2011.
Margaret A. Hamburg,
Commissioner of Food and Drugs.
[FR Doc. 2011-25907 Filed 10-6-11; 8:45 am]
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