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# Sponsors Must Self-Identify Combination Products: FDA
- URL: https://www.fdaweb.com/sponsors-must-self-identify-combination-products-fda/
- Published: 2018-03-28T12:00:00.000Z
- Updated: 2026-09-14T23:55:39.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5141083

CDRH reviewed in a 3/20 [Webinar](https://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/ucm594828.htm?ref=fdaweb.com) contents of two updated guidances that implement provisions of the 21st Century Cures Act — the acceptance and filing a review for PMA applications guidance and the refuse-to-accept policy for 510(k) guidance. CDRH Office of Device Evaluation policy analyst **James Bertram** said the Cures Act requires sponsors of combination products to appropriately self-identify their product as such. And, if the product is a device-led combination and includes a drug constituent that was previously approved by CDER, the sponsor must provide the appropriate patent certification and consider whether any NDA is protected by exclusivity.

Bertram said the agency has updated its refuse-to-accept checklist to take into account these new provisions, helping to ensure that the necessary information is present for the agency to make its decisions.

“In summary,” Bertram said, “to ensure compliance with the provisions set forth in Cures regarding combination product self-identification, we recommend that you include a statement in your cover letter and product description that basically states that you identify your product as a combination product.”