Petition Calls on FDA to Set Timeline for Designation Appeals Process

March 14, 2017

A law firm has filed a citizen petition calling on the FDA to reduce delays in the appeals process for device designations.

Appeals for some products are particularly susceptible to delays, the Epstein Becker & Green petition says, including combination products that the manufacturers believe are more appropriately designated as devices or device-led combination products.

Under current FDA regulations, drugmakers have the option to appeal a designation to the agency’s Associate Commissioner of Special Medical Programs. However, the agency has no set timeline for how soon the associate commissioner must act on those appeals, which has caused significant delays.

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