Tag:
PMAs
Latest Headlines
Latest Headlines
GAO: FDA device approval times drastically slower
Many in the medical device industry see the FDA approval process as only having gotten more cumbersome and slow. A new report from the Government Accountability Office adds more fuel to the fire.
FDA looks to clarify benefit-risk determinations for medical devices
The FDA today has provided draft guidance clarifying how benefit-risk determinations are made during premarket review of certain medical devices. The guidance, which focuses on PMAs, is intended to
Report: Women underrepresented in heart device studies
Medical devicemakers are required to include women in studies they submit for approval. But research published in Circulation: Cardiovascular Quality and Outcomes shows only a few studies include
