Commenters Seek Changes in Product Jurisdiction Rule
Cook Group says it believes that an FDA proposed rule on product jurisdiction will assist the agency to achieve its public health mission. Its comment letter requests clarifications or changes to the proposal’s language on clarifying the scope of the regulations, streamlining and clarifying the appeals process, aligning the regulations with more recent legislative and regulatory measures, updating advisory content, and otherwise clarifying the rule.
Hyman, Phelps & McNamara requests that in addition to other updates, FDA (1) establish a timeframe for the Office of Combination Products to reach a determination on a sponsor’s request for determination, and (2) remove the 15-page limitation for requests for designation.
Finally, AdvaMed says it is concerned that some of the proposed revisions in the rule run counter to the plain language and intent of the relevant section of the 21st Century Cures Act. The association offers actions to resolve its concerns.