FDA Unveils Software Pre-Cert Working Model, Test Plan, Reg Framework

FDA issued a batch of announcements on Monday (Jan. 7) aimed at shoring up support for its software precertification test program, including a new pre-cert working model, a 2019 test plan and a regulatory framework. In a bid to assuage stakeholders’ concerns that the agency lacks authority for the program, FDA stressed it would implement the pre-cert test under the de novo pathway at first, and, depending on how the test goes, might seek other regulatory authorities. The agency’s goal...