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# Warren, Murray Want More Device Approval Answers
- URL: https://www.fdaweb.com/warren-murray-want-more-device-approval-answers/
- Published: 2019-11-05T12:00:00.000Z
- Updated: 2026-09-14T15:51:48.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5145426

Sens. **Elizabeth Warren** (D-MA) and **Patty Murray** (D-WA) say they were “disappointed” to learn that FDA no longer fully stands by a commitment made by former commissioner **Scott Gottlieb** to not use a conditional approval pathway for human medical products. In an 11/4 [letter](https://www.warren.senate.gov/imo/media/doc/2019.11.04%20Follow%20up%20letter%20to%20FDA%20re%20provisional%20approval%20of%20medical%20devices1.pdf?ref=fdaweb.com) to FDA acting commissioner **Brett Giroir** and CDRH director **Jeffrey Shuren**, the senators reference an agency 8/21 [response](https://www.warren.senate.gov/imo/media/doc/2019-2475%20RESPONSE%20WARREN.pdf?ref=fdaweb.com) to their 6/24 letter on an agency legislative proposal to create a “progressive approval” pathway for human medical devices.

“We recognize the challenges in developing medical and surgical devices for populations with unmet medical needs,” Warren and Murray write. “However, we continue to have questions regarding the eligibility criteria FDA envisions for this proposal, FDA’s ability to ensure the quality and completeness of postmarket data collection; and the agency’s ability to exercise its authority to remove medical products from the market after they have been provisionally approved.”

The senators ask for answers to seven questions on the operation of a progressive approval pathway.