Combination Product Designations At US FDA Need Faster Appeals, Petition Says
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.
You may also be interested in...
Commissioner Gottlieb says upcoming guidance could help nudge products into preferred device realm if they are on cusp between drug or device jurisdictional designation.
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.
US FDA's tendency to designate products as drugs over devices may remain despite clarifications offered in final guidance.