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The FDA needs to do more to ensure the cybersecurity of networked medical devices, according to a new report from the HHS Office of Inspector General. Read More
The agency still has concerns about use of the stents for cardiovascular indications unless they have been cleared for CV indications through a PMA. Read More
AdvaMed asked the FDA for more examples of combination product types and manufacturing processes for which good manufacturing practices diverge from standard combination product CGMPs. Read More
Manufacturers receiving a heparin sodium drug substance or API represented as “USP” for use in a combination product should document that the substance has been tested according to the current USP drug substance monograph, the agency said. Read More
The agency plans on working with the International Medical Device Regulators Forum on a standard format to support electronic device submissions. Read More
FDA Commissioner Scott Gottlieb said the third-party reviews “must be equivalent in rigor and completeness to the kinds of reviews that we’d conduct.” Read More
AdvaMed asked the FDA to give more examples of combination product types and manufacturing processes for which good manufacturing practices diverge from standard combination product CGMPs. Read More