Blazing new trails between pharma and medical device is intimidating, particularly when it comes to reconciling the different drug and device product registration requirements. Most pharma people I meet comment on how complicated it seems to get approval on a device. (My reaction is the opposite—I can’t image the complexity of working towards a drug approval!) There is information out there if you know where to look. The FDA’s Office of Combination Products is a great place to start.

If you’re trying to obtain approval on a drug-device combination product, the consensus from the FDA is that the product should satisfy the higher regulatory requirement, which is pharma. So, you would want to develop an appropriate cGMP quality compliance strategy that is pharma-based, i.e., 21 CFR 210/211 compliant, with device requirements (21 CFR 820.30) built in.

For the device portion, don’t reinvent the wheel. Start researching like devices, competitors and existing 510(k) applications/approvals on the FDA’s 510(k) Database. Social media is another great information source. Medical device interest groups on LinkedIn and other social channels host lively discussions about device-related issues, including combination products. You don’t have to share trade secrets or design specs, but there’s no harm in obtaining clarification on data that’s already out there.

Alex Butler, MasterControl’s Medical Device Segment Manager