FDA makes case for new regulatory paradigm amid hurdles in software-oversight program

The FDA proposed the precertification program to adapt regulatory processes originally intended for hardware to the faster development and update cycles of software as a medical device. The plan was to offer a streamlined regulatory review to some organizations, based on their quality culture and commitment to monitoring the real-world performance of their products.

To pilot the model, the agency enrolled nine participants. The report published by the FDA this week sets out what happened in the pilot program, concluding the initiative in the process, and describes what the agency thinks needs to happen next.

The pilot program was unable to assess the approaches on a broad range of devices because of the small number of participants and the need to limit formal implementation to De Novo classification, the FDA said. When De Novo classification was appropriate, the adoption of the approaches would have resulted in the creation of special controls that would apply to devices with substantial equivalence outside of the program, it added.

Despite those challenges, the regulator was able to use the pilot program to identify changes that could help oversight of software going forward. The agency said it sees benefits to a new regulatory paradigm that enables it to “continually assess an organization’s ability to deliver devices with a commitment to a culture of quality and organizational excellence” and provides ongoing visibility into key performance indicators.

“A flexible, risk-based approach to regulation could allow FDA to tailor regulatory requirements more efficiently for devices based on the latest science, the benefits and risks posed by devices, their real-world performance, and their contribution to promoting health equity,” the regulator wrote. “New legislative authority establishing such an approach could be supplemental to, and not replace, the established regulatory pathways.”

Dive Brief:

• The Food and Drug Administration has concluded it’s impractical to implement the agency’s proposed software precertification program under its current statutory and regulatory authorities.
• A pilot assessment of the program ran into challenges, including the realization that the De Novo submission-based approach outlined in the FDA’s 2019 plan was not the optimal test method.
• The regulator concluded that the “rapidly evolving technologies in the modern medical device landscape” would benefit from “a new regulatory paradigm.” A legislative change will be needed to implement that paradigm, the FDA said in a report released Monday.

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