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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The Medicines and Medical Devices Act presses the UK to regulate in such a way that makes the market attractive for industry and investment. Medtech manufacturers insist the MHRA must strike the right balance as it brings its ‘plan for a new agency’ to life, said the ABHI’s Phil Brown, in the second of a two-part industry view of UK medtech’s regulatory future.
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.