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The Global Diagnostic Imaging Healthcare IT & Radiation Therapy Trade Association is calling on the FDA and the Medical Device Single Audit Program consortium to review the program’s inconsistencies and revise companion documents so devicemakers and auditing organizations are clear on expectations. Read More
Applications must include, at a minimum, the ARTG number for the device type the sponsor wishes to export, as well as the global medical device nomenclature codes. Read More
The program gives manufacturers access to FDA and payor feedback during pre-submission meetings on more efficient evidence generation strategies. Read More
AdvaMed is paying close attention to an initiative by HHS that could impact pricing arrangements for medical devices by adding safe harbors to the federal anti-kickback statute. Read More