News & Events

FDA in Brief: FDA Takes Additional Steps to Encourage Innovative Medical Product Development

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  Lauren Smith Dyer
  301-348-1888

"The Agency is building on progress made towards modernizing the FDA’s review program for cross-cutting products, including combination products, by improving coordination and enhancing clarity, to ensure consistency and increase efficiency. These medical products require a thoughtful, innovative approach to regulation," said FDA Principal Deputy Commissioner Rachel Sherman.  "The FDA is working to ensure we find the right path for these products to ensure that the patients who need them gain access as quickly as possible."

Today the FDA announced a public hearing to discuss a potential approach for premarket review of medical devices intended for a new use with an approved, marketed drug when the sponsor for the approved drug does not wish to pursue or collaborate on the new use.  These devices are referred to as "devices referencing drugs," or DRDs.  DRDs have the potential to advance public health by offering new uses of approved, marketed drugs that might not otherwise be developed.  However, DRDs also raise unique public health, scientific, regulatory, and legal issues.  Although the FDA has previously held a meeting on this topic, the agency has now outlined a potential approach  for premarket review of proposed DRDs and invites public input on this potential approach during the November 16, 2017 hearing and through comments to the hearing docket.

The FDA also issued a final guidance, Classification of Products as Drugs and Devices & Additional Product Classification Issues, providing greater clarity concerning the agency’s approach to classifying products—including constituent parts of combination products—as drugs or devices.  The FDA regularly receives requests from medical product developers concerning whether their product should be classified as a drug, a device or a combination product.  The agency believes providing as much clarity and predictability as possible with respect to product classifications will enable better planning for product development. 

For more information:

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.
 

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Page Last Updated: 03/23/2018
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