FDA Final Guidance On Drug/Device Classifications Misses The Mark, Attorneys Say
The final guidance adds some requested clarifications, but does not appear to address the US agency's tendency to designate products as drugs over devices, industry attorneys argue.
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US FDA Commissioner Scott Gottlieb told a Medical Device Manufacturers Association crowd that he will try to assure more balance between device and drug regulatory leads for combination product reviews at the agency.
No sponsor is named in the citizen petition, but it was filed on behalf of an applicant that has had an appeal of a designation decision 'under consideration' for 18 months and counting.
The agency is still working to get an oncology center of excellence off the ground and has other large pending reorganizations to tackle before it may get to creating additional centers intended to break down device, drug and biologic silos.