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Regulatory Focus™ > News Articles > 2019 > 11 > Senators ‘Disappointed’ by FDA’s Pivot on Progressive Approvals for Devices

Senators ‘Disappointed’ by FDA’s Pivot on Progressive Approvals for Devices

Posted 05 November 2019 | By Michael Mezher 

Senators ‘Disappointed’ by FDA’s Pivot on Progressive Approvals for Devices

In a letter to top US Food and Drug Administration (FDA) officials on Monday, Sens. Elizabeth Warren (D-MA) and Patty Murray (D-WA) say they are concerned about the agency’s renewed interest in a progressive approval system for certain medical devices.
The letter, addressed to Acting FDA Commissioner Brett Giroir and Center for Devices and Radiological Health (CDRH) Director Jeffrey Shuren, questions the agency’s about-face on progressive approvals for devices after former FDA Commissioner Scott Gottlieb told senators in 2018 that a conditional approval pathway would not be suitable for human medical products.
While progressive approvals for devices have been discussed for years, FDA first officially proposed the pathway in its FY2020 budget justification. Under the proposal, certain devices could be marketed under a provisional approval based on a demonstration of safety and performance in addition to other risk mitigations for a three-year period. Afterward, the sponsor would be required to demonstrate a reasonable assurance of safety and effectiveness based on postmarket data to continue marketing the device.
In response to the proposal, Warren and Murray sent a letter to Shuren and then-Acting FDA Commissioner Ned Sharpless in June calling the proposal “alarming” and noting that “as written, this ‘provisional approval’ seems hardly distinguishable from the ‘conditional approval’ that former-Commissioner Gottlieb had assured Congress and the public that the FDA would not pursue.”
FDA Associate Commissioner for Legislative Affairs Karas Gross responded to the senators in August, explaining that, “The agency’s views with respect to medical devices have continued to evolve.”
“This pathway is intended to help enable access to medical devices which treat or diagnose life-threatening or irreversibly debilitating diseases and conditions and address unmet medical needs, particularly for children and other small and rare populations that remain perpetually underserved,” Gross wrote.
In response, Warren and Murray say they are “disappointed by FDA’s clarification” and continue to have concerns about the agency’s envisioned eligibility criteria for progressive approval and the “quality and completeness” of the postmarket data that would be used to fully approve devices under the pathway.
The senators also question how well the agency would be able to remove provisionally approved devices from the market if they are unable to demonstrate a reasonable assurance of safety and effectiveness after the provisional approval period expires.
Statement, Letter


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