FDA Moving On Pre-Cert Test Plan Despite Questions About Authority

Despite lingering questions surrounding FDA’s authority to implement its software precertification program , the agency is moving forward with a pre-cert test program in which it hopes to test out its pre-cert model with a range of software companies. As the agency issued a call on Wednesday (May 22) for volunteers, one device industry lawyer questioned how useful participating in the 2019 test plan would be for companies, since they will not be awarded with precertification status at the end...