US Senators Question FDA's Pre-Cert Program Authority, Concerned About Safety
Top Democratic lawmakers on the Senate HELP Committee have written to US FDA Commissioner Scott Gottlieb with questions about the agency's ongoing work to develop a pre-certification program that would allow medical software-makers to gain the agency's trust as a means to benefit from reduced or no pre-market review.
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In 2019, FDA will be taking steps to perform real-world testing of the effectiveness of its pre-cert program for health software and whether the program can be carried out within the agency's current regulatory authorities. The efforts come after more than a year of development and some pushback about statutory overreach and patient safety.
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The agency is building its pre-certification program as a novel paradigm for health software products to reach the market with less scrutiny when companies successfully undergo "excellence" appraisals. It has attracted the interest and support of many stakeholders, but at least one medtech group argues the agency should have to get congressional approval to launch the program.