Senate Democrats question if FDA's digital health pre-certification will 'compromise public safety'

Three Democratic senators are requesting additional information about the FDA's Pre-Cert for Software Pilot Program, a streamlined regulatory pathway for digital health technologies that the agency unveiled in July 2017.

Elizabeth Warren (Mass.), Patty Murray (Wash.) and Tina Smith (Minn.) penned an Oct. 10 letter in response to the FDA's recent decision to clear an electrocardiogram sensor that Apple had developed for its latest smartwatch. The senators questioned how the FDA plans to clear future digital health tools, and whether the Pre-Cert for Software Pilot Program — which included Apple, along with eight other companies — was in compliance with existing regulatory requirements.

The FDA launched the pre-cert program in 2017 as part of part of its Digital Health Innovation Action Plan. The pilot aimed to streamline approval for "Software-as-a-Medical-Device," or SaMD, technologies by reviewing developers, rather than individual products. These pre-certified developers would be able to launch products without FDA review, so long as the developers collect post-market data to confirm product safety.

"FDA has outlined an ambitious set of goals for establishing a pre-certification program for SaMDs," the senators wrote in the letter, addressed to FDA Commissioner Scott Gottlieb, MD, and FDA Center for Devices and Radiological Health Director Jeffrey Shuren, MD. "We appreciate that FDA continues to gather stakeholder input on the design of this program; however, we have a number of concerns with the vision of the program laid out over the past year."

Here are five of the questions the senators asked Dr. Gottlieb and Dr. Shuren in the letter:

1. "Pre-certified entities will qualify for streamlined or no pre-market review for an SaMD, even for an SaMD that is moderate or high-risk … What is the public health justification for FDA to abandon its authority to conduct a full review for a high-risk product?"

2. "What is the public health justification for not allowing an entity's pre-certification to expire and establishing a recertification or maintenance process?"

3. "FDA anticipates pre-certifying at a business unit or center of excellence level, rather than a corporate level … How does FDA plan to oversee and enforce these boundaries?"

4. "FDA proposes utilizing third parties to conduct pre-certification assessments, meaning that FDA will not be reviewing all SaMD products, nor reviewing the entities themselves … What existing third party entities does FDA believe have the capacity and expertise to conduct such assessments?"

5. "It is clear that [the FDA's Center for Devices and Radiological Health] is making major efforts to address the rapidly evolving digital health sector efforts. However, cross-center efforts are less clear … Who is coordinating digital health regulatory policy across FDA?"

"We support FDA's efforts to update the medical device review regime to better accommodate digital health devices," the senators wrote. "However, it is essential that changes to FDA's regulatory framework are done in compliance with the current statutory framework and do not compromise public safety."

The senators requested the FDA address their questions by Nov. 9.

To download the senators' letter, click here.

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