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.