FDA Adds Device Scenarios to Final GMP Guidance for Combo Products

The FDA finalized guidance on GMP requirements for combination product manufacturers, adding scenarios to clarify how to comply with certain device requirements.

The 59-page guidance — which covers GMP requirements for drug-drug, drug-device, drug-biologic and biologic-device combination products — is largely the same as the 2015 draft guidance, except for the addition of compliance examples for prefilled syringes, drug-coated mesh and drug-eluting stents.

When a manufacturer intends to apply for marketing approval for a prefilled syringe containing a previously approved drug product, the manufacturer must demonstrate compliance with both the drug GMPs and device quality system regulations, the guidance said. — Derek Major