[Federal Register Volume 81, Number 205 (Monday, October 24, 2016)]
[Pages 73113-73115]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-25659]



Centers for Medicare & Medicaid Services


Food and Drug Administration

[Docket No. FDA-2010-N-0308]

Program for Parallel Review of Medical Devices

AGENCY: Food and Drug Administration; Centers for Medicare & Medicaid 
Services, HHS.

ACTION: Notice.


SUMMARY: The Food and Drug Administration (FDA) and the Centers for 
Medicare & Medicaid Services (CMS) (the Agencies) are informing the 
public that the Parallel Review of medical devices pilot program will 
be fully implemented and extended indefinitely. The Agencies are 
soliciting nominations from manufacturers of innovative medical devices 
to participate in the ``Program for Parallel Review of Medical 
Devices.'' The Parallel Review program is a collaborative effort that 
is intended to reduce the time between FDA marketing approval or FDA's 
granting of a de novo request and Medicare coverage decisions through 
CMS's National Coverage Determination (NCD)

[[Page 73114]]

process. This program is intended to ensure prompt and efficient 
patient access to safe and effective and appropriate medical devices 
for the Medicare population.

DATES: The program described in this document for parallel review for 
medical devices is effective October 24, 2016. The program will be 
fully implemented as of the date of the publication of this document in 
the Federal Register.

FOR FURTHER INFORMATION CONTACT: For device manufacturers interested in 
Parallel Review and for general questions: Murray Sheldon, Center for 
Devices and Radiological Health, Food and Drug Administration, 301-796-
5443, [email protected]. For questions related to devices 
reviewed by Center for Biologics Evaluation and Research: Stephen 
Ripley, Center for Biologics Evaluation and Research, Food and Drug 
Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301, Silver 
Spring, MD 20993, 240-402-7911. For general questions about the NCD 
process: Tamara Syrek Jensen, Centers for Medicare and Medicaid 
Services, 410-786-3529, [email protected].


I. Background

A. Parallel Review Pilot Program's History

    As discussed in the September 17, 2010, Federal Register notice (75 
FR 57045), the Agencies announced their intention to initiate a 
Parallel Review pilot program that would establish a process for 
overlapping evaluation of clinical evidence for premarket, FDA-
regulated medical devices in order to reduce the time between FDA 
marketing approval or FDA's granting of a de novo request and a 
Medicare NCD. The Agencies piloted the program in an effort to increase 
quality of patient health care by facilitating earlier access to 
innovative medical technologies for Medicare beneficiaries.
    In the October 11, 2011, Federal Register notice (76 FR 62808), the 
Agencies provided notice of the procedures for voluntary participation 
in the pilot program as well as the guiding principles they intended to 
follow during the program. In the December 18, 2013, Federal Register 
notice (78 FR 76628), the Agencies extended the duration of the pilot 
program for an additional 2 years.
    Currently, the Agencies appreciate the full potential of the 
parallel review program and realize the positive impact of the pilot, 
and have now decided to transition into a permanent program.

B. Purpose of Parallel Review

    Parallel Review allows both Agencies to review information about a 
medical device concurrently, rather than sequentially, while continuing 
to make their premarket review and coverage decisions consistent with 
their respective statutory authority. FDA works to ensure that only 
safe and effective medical devices are marketed in the United States. 
CMS makes coverage decisions for medical technologies, which are 
reasonable and necessary for the Medicare population. Neither FDA's 
premarket review criteria nor CMS's coverage processes criteria change 
when a medical device is accepted into the parallel review program.

C. Lessons Learned From the Parallel Review Pilot Program

    The Agencies learned two primary lessons from the Parallel Review 
pilot program. First, they found that manufacturers benefit from 
engaging both Agencies at the pivotal clinical trial design phase. The 
feedback that manufacturers receive from both Agencies at the pivotal 
clinical trial design stage can assist manufacturers in designing 
pivotal trials that can answer both Agencies' evidentiary questions. 
Thus, it is more likely that manufacturers will only need to conduct a 
single pivotal clinical study rather than several pivotal clinical 
studies to satisfy both Agencies.
    Second, concurrent review by the Agencies of clinical evidence can 
reduce the time from FDA premarket approval or the granting of a de 
novo request to an NCD. For example, on August 11, 2014, FDA approved a 
medical device that was part of the Parallel Review Pilot Program. On 
the same day, CMS initiated its national coverage analysis (NCA). CMS 
published a favorable final NCD on October 9, 2014, less than 2 months 
after the medical device received its premarket approval and 7 months 
before the NCD statutory due date.

II. Parallel Review Program

    Based on the positive experience from the Parallel Review Pilot 
Program, both Agencies have decided to extend the Parallel Review 
program indefinitely.

A. Parallel Review Process

    The program has two stages: (1) The pivotal clinical trial design 
development stage, and (2) the concurrent evidentiary review stage. The 
manufacturer should submit a request for parallel review prior to the 
start of the first stage by sending an email to [email protected], which indicates their interest in the program and 
includes the following information:
    1. Nomination of manufacturer:
     Name of the manufacturer and relevant contact information;
     name of the product;
     succinct description of the technology and disease or 
condition the device is intended to diagnose or treat; and
     state of development of the technology (that is, in pre-
clinical testing, in clinical trials, currently undergoing premarket 
review by FDA)
    2. A statement that the manufacturer intends to meet jointly with 
FDA and CMS using FDA's Pre-Submission program (Ref. 1), or other 
mechanisms that allow for meetings of the three parties to gather and 
incorporate feedback from both Agencies about the design and analysis 
of their pivotal clinical trial, to support a marketing application and 
a National Coverage Determination.
    3. A statement that the medical device will require an original or 
supplemental application for premarket approval (PMA) or the granting 
of an FDA de novo request;
    4. The medical device is not excluded by statute from Part A and/or 
Part B Medicare coverage (and the request for parallel review includes 
a list of Part A and/or Part B Medicare benefit categories, as 
applicable, into which the manufacturer believes the medical device 
falls); and
    5. A statement that the medical device addresses the public health 
needs of the Medicare population (and the request for parallel review 
includes an explanation of how).
    Upon completion of the pivotal trial and submission of an original 
or supplemental PMA, or a de novo request, the Agencies intend to 
review the pivotal clinical trial evidence concurrently (``in 
parallel''). Both Agencies will independently review the data to 
determine whether it meets their respective Agency's standards and 
communicate with the manufacturer during their respective reviews.
    Manufacturers and each Agency have the option to withdraw from the 
Parallel Review Program until CMS opens the NCD by posting a tracking 
sheet. For example, if the manufacturer would like to withdraw from the 
program after the pivotal trial, but before the NCA tracking sheet is 
posted, that would be acceptable. More information on the NCD process 
is set forth in the August 7, 2013 Federal Register notice (78 FR 
48164). Once a tracking sheet is posted, CMS must complete the 
statutorily defined NCD process.

[[Page 73115]]

B. Candidate Prioritization

    The Agencies intend to review Parallel Review requests and respond 
within 30 days after receipt of the email. The Agencies intend to 
prioritize innovative medical devices that will benefit from the 
efficiencies of the Parallel Review. Priority will also be given to 
medical devices expected to have the most impact on the Medicare 
population. An FDA marketing approval does not guarantee a favorable 
coverage decision.

III. Paperwork Reduction Act of 1995

    As stated in previous Federal Register notices related to the 
Parallel Review pilot, due to FDA and CMS resource issues, the 
permanent program will follow the same capacity limit by accepting no 
more than five candidates per year. As such, like the pilot program, 
this collection of information does not meet the definition of an 
information collection, as defined under 44 U.S.C. 3501-3520.

IV. References

    The following references are on display in the Division of Dockets 
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852, and are available for viewing by 
interested persons between 9 a.m. and 4 p.m., Monday through Friday; 
they are also available electronically at http://www.regulations.gov. 
FDA has verified the Web site addresses, as of the date this document 
publishes in the Federal Register, but Web sites are subject to change 
over time.

    1. FDA Guidance, ``Requests for Feedback on Medical Device 
Submissions: The Pre-Submission Program and Meetings with Food and 
Drug Administration Staff.'' Available at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM311176.pdf.

    Dated: October 18, 2016.
Leslie Kux,
Associate Commissioner for Policy, Food and Drug Administration.
    Dated: October 5, 2016.
Andy Slavitt,
Acting Administrator, Centers for Medicare & Medicaid Services.
[FR Doc. 2016-25659 Filed 10-21-16; 8:45 am]