FDA Offers Advice on Drug Master Files for CDER-Led Combination Products
Sponsors of CDER-led drug-device combination products that include electronics or software should include specific technical information in their Type V drug master files, the FDA said in a draft guidance.
The guidance applies to combination products that include devices such as those used for drug delivery — an electromechanically driven pen injector with software that analyzes dosing, for example.
Following CDER’s review of a Type V drug master file, the device information may be used to support multiple CDER submissions, including an IND, NDA, ANDA, BLA, or amendments and supplements to those applications, or another DMF, the agency said.
“Because of rapid advances in technology, the device constituent part in… combination products could be modified frequently,” the agency noted, adding that sponsors should submit an amendment to a Type V DMF for any modifications to the device constituent part.