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# Warren, Murray Question CDRH Progressive Approval
- URL: https://www.fdaweb.com/warren-murray-question-cdrh-progressive-approval/
- Published: 2019-07-08T12:00:00.000Z
- Updated: 2026-09-15T01:36:02.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5144466

Sens. **Elizabeth Warren** (D-MA) and **Patty Murray** (D-WA) have written to FDA acting commissioner **Ned Sharpless** expressing their opposition to the CDRH “progressive approval for devices” program in the FDA FY 2020 budget that appears to expand the agency’s “conditional approval” pathway for animal drugs to human medical products. Their 6/24 [letter](https://www.warren.senate.gov/imo/media/doc/2019.06.24%20Letter%20to%20FDA%20re%20Progressive%20Approval%20for%20Medical%20Devices.pdf?ref=fdaweb.com) says they had been assured by former commissioner **Scott Gottlieb** that such a program expansion would not take place.

“We strongly oppose the expansion of the conditional approval pathway to human drugs and devices,” the two write, “and we are seeking clarification on whether FDA is pursuing this policy despite then-commissioner Gottlieb’s commitments to the contrary.”

The letter asks Sharpless for answers to these questions: 

- whether FDA stands by Gottlieb’s statements about the conditional approval pathway;
- how progressive approval differs from conditional approval;
- how an approach to sunsetting approval of a medical device included in the FY 2020 budget proposal complies with procedural due process requirements;
- how the decision to include the progressive approval for medical devices in the budget proposal was made;
- an update on FDA efforts to implement its progressive approval for medical devices program; and
- an update on new CDRH policies and internal procedures shown in its strategic priorities to transition from a risk-based framework for medical device regulation to a benefit-risk framework that makes explicit the societal tradeoffs of Center decisions and gives regulatory options depending on the tradeoffs.