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The FDA extended the compliance date for Global Unique Identification Database (GUDID) submission requirements for combination products, giving devicemakers another year to comply. Read More
The FDA issued a list of medical device accessories that it believes are safe and effective enough to be categorized as Class I and requested public feedback on the proposed list. Read More
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 system generates a prescription defining incremental adjustments to be made to the spatial frame’s strut that will correct the deformity. Read More
The agency said 3D-printed devices are subject to the same pre- and post-market requirements as conventionally manufactured devices, but there are additional considerations. Read More
The program gives manufacturers access to FDA and payor feedback during pre-submission meetings on more efficient evidence generation strategies. Read More