Proposed Combo Products Rule Underestimates Cost of GMPs

The FDA’s proposed rule on GMPs for combination products underestimates the burden of applying certain cGMP requirements to drug-device combinations, industry says.

The device quality system (QS) approach of “designing in quality” based on risk seems to conflict with the drug cGMP approach of “testing in quality” via requirements for batch release testing, Biotronik says in a comment on the rule.

The proposed rule doesn’t address these differences, which could be a problem for single entity drug-device combination products seeking approval primarily as a device, the company notes. Biotronik produces medical products for vascular intervention and cardiac electrotherapy.
Drug GMP Report