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Industry Proposes Its FDA Guidance Priorities, Reforms

After FDA published its annual lists of guidance priorities, industry has responded by stating what guidances companies would like to see. Meanwhile, the push for broader reforms to the guidance-development process continues.

Device companies agree with CDRH that issuing final guidance on when postmarket data can replace premarket data, on its plan to regulate laboratory-developed tests and on needed tests to assess the biocompatibility of new device materials are top priorities for fiscal year 2015, but firms also believe the device center left some documents off of its priority list for the year.

AdvaMed, the 510(k) Coalition and other stakeholders highlighted top industry guidance priorities in response to CDRH's annual 'A-list' and 'B-list' guidance plans posted

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