News | October 17, 2011

FDA, CMS Develop Parallel Review Process

October 17, 2011 — The U.S. Food and Drug Administration (FDA) and the Centers for Medicare and Medicaid Services (CMS) have established a pilot program for concurrent review of medical devices. Under the process, certain FDA premarket review submissions and CMS national coverage determinations will be simultaneously reviewed.

Reducing the interval between FDA marketing approval and medical reimbursement coverage will facilitate development and shorten the time it takes to bring products to patients.

During its pilot phase, the agencies said they will offer to perform parallel review for up to five innovative devices per year. Appropriate candidates are medical devices that meet one of the following criteria:

  1. New technologies for which the sponsor/requester has a pre-investigational device exemption (IDE) or an approved IDE application designation.
  2. New technologies that would require an original or supplemental application for premarket approval (PMA) or a petition for de novo review.
  3. New technologies that fall within the scope of a Part A or Part B Medicare benefit category and are not subject to a national coverage decision (NCD).


The pilot program is voluntary and will not change the existing separate and distinct review standards for FDA device approval and CMS coverage determination. It is only available for medical device technologies that meet the above criteria.

For more information: www.fda.gov, www.cms.gov

Related Content

A lung CT of a COVID-19 patient, showing ground-glass opacities in the lung from COVID pneumonia. Image courtesy of John Kim.

A lung CT of a COVID-19 patient, showing ground-glass opacities in the lung from COVID pneumonia. Image courtesy of John Kim.

News | Coronavirus (COVID-19) | July 09, 2020
July 9, 2020 — With increased lung CT exam paradigms being used in the current...
This data represents wave 2 of a QuickPoLL survey conducted in partnership with an imagePRO panel created by The MarkeTech Group (TMTG), regarding the effects of COVID-19 on their business

Getty Images

Feature | Coronavirus (COVID-19) | July 01, 2020 | By Melinda Taschetta-Millane
In new QuickPoLL survey on imaging during the pandemic, responses were tallied from around 170 radiology administrators and business managers, who are part of an imagePRO panel created by The MarkeTech Group (TMTG), regarding the effects of COVID-19 on their business. TMTG is a research firm specializing in the medical device, healthcare and pharmaceutical industries.
Feature | Coronavirus (COVID-19) | June 30, 2020 | By Melinda Taschetta-Millane
he FDA launched the first “FDA Insight” podcast, featuring FDA Commissioner Stephen Hahn, M.D., and FDA Deputy Commissioner for Medical and Scientific Affairs Anand Shah, M.D., discussing FDA's COVID-19 efforts, including the drug development process for a COVID-19 treatment.

Getty Images

News | Coronavirus (COVID-19) | June 25, 2020
June 25, 2020 — The FDA launched the first “...
Signs for "Heroes work here" outside healthcare facilities and even the homes of clinicians have popped up across the country. This photo shows healthcare workers at the Lenox Health emergency room entrance being greeted to cheers and thanks for their essential service during the COVID-19 pandemic in New York City at a public thank you event May 21, 2020.

Signs for "Heroes work here" outside healthcare facilities and even the homes of clinicians have popped up across the country. This photo shows healthcare workers at the Lenox Health emergency room entrance being greeted to cheers and thanks for their essential service during the COVID-19 pandemic in New York City at a public thank you event May 21, 2020.

News | Coronavirus (COVID-19) | June 24, 2020
June 24, 2020 — During the height of the COVID-19
Two leading organizations join forces to drive future telehealth strategies across hospital settings into the home propelled by COVID-19
News | Teleradiology | June 18, 2020
June 18, 2020 — Philips announced it has once again joined forces with the American Telemedicine Association (...