FDA Pre Cert

Roche, J&J regulatory leads weigh in on Pre-Cert's progress, challenges of regulating digital health
By Dave Muoio | 01:09 pm | June 04, 2019
At BIO 2019 in Philadelphia, a panel of industry experts discussed their experiences with the FDA's pilot program; ambiguities in drug, device and software pathways; and the hurdles digital health regulation has yet to properly address.
Commentary: Why FDA’s software precertification program may be bad for business
By Bradley Merrill Thompson | 12:20 pm | September 07, 2018
Epstein Becker & Green's Bradley Merrill Thompson says the FDA's much-touted program is riddled with unseen costs and unanswered questions.