Bradley Merrill Thompson
As the agency's workload swells with the weight of a public health emergency, digital health companies on a timeline should consider whether their products truly warrant a regulatory submission, writes Epstein Becker & Green's Bradley Merrill Thompson.
Epstein Becker & Green's Bradley Merrill Thompson explains why the FDA PreCert Program's built-in subjectivity and bias toward established entities should worry the healthcare and medical technology industry.
Roche, J&J regulatory leads weigh in on Pre-Cert's progress, challenges of regulating digital health
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.
Ironically, the agency that goes after companies for false and misleading claims is making them about its own policies.
While key details are still missing, the picture that's emerging is surprisingly restrictive
FDA Comissioner Dr. Scott Gottlieb announced a new Digital Health Innovation Action Plan, Pre-Cert Test Plan for 2019 and a Working Model.
Epstein Becker & Green's Bradley Merrill Thompson says the FDA's much-touted program is riddled with unseen costs and unanswered questions.