[Federal Register Volume 76, Number 196 (Tuesday, October 11, 2011)]
[Notices]
[Pages 62808-62810]
From the Federal Register Online via the Government Printing 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: markham.luke@fda.hhs.gov.

    For General questions about parallel review:

Peter Beckerman, Office of Policy, Food and Drug Administration, 301-
796-4830, e-mail: peter.beckerman@fda.hhs.gov or
Tamara Syrek Jensen, Centers for Medicare and Medicaid Services, 410-
786-3529, e-mail: Tamara.Syrekjensen@cms.hhs.gov.

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: parallel-review@fda.gov, 
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

[[Page 62810]]

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]
BILLING CODE 4160-01-P