Single Marketing Application Review For Multiple Jurisdictions On Horizon
Medical device makers could get their products to markets around the world faster if plans for a single premarket review program by international regulators go ahead.
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Conformity And Confidence: US FDA Seeks To Build Trust In Pre-Market Standards Declarations With ASCA Pilot
FDA hopes the Accreditation Scheme for Conformity Assessment pilot will make it easier to trust the declarations of conformity to standards that are made by device-makers in pre-market submissions, rather than having to ask a lot of time-consuming questions. ASCA, included in the latest FDA user-fee agreement, also has important implications for the agency's global harmonization efforts. But many questions remain about its value and viability; they were on display at a recent two-day workshop at the agency's headquarters.
While Congress makes its push to reauthorize US FDA user fees by mid-summer, here are 10 important details from the underlying industry-agency user-fee agreements that medtech firms should know.
US FDA's device-center head discussed his continued push to make regulations more flexible, plans for least-burdensome training and what's next for NEST, among other topics, at the Food & Drug Law Institute annual gathering in Washington DC.