Coalition calls for FDA to answer questions regarding regulating clinical software

The Clinical Decision Support (CDS) coalition has written to the FDA to answer 26 questions regarding the regulation of clinical software products.

The CDS coalition, made up of software developers, medical device developers and health IT personnel, has asked the FDA a series of 26 questions regarding how the agency plans to regulate technological products as medical devices.

Apps, wearable technology and other products are flooding the market with new ideas for treating disease, but the FDA has been slow to regulate the incoming products. Without a set plan when regulating technology, the FDA is now being put on the hot seat by this coalition to create a guide for companies developing medical technology.

Citing three case studies, the CDS coalition uses examples of devices, such as an app that tracks multiple sclerosis, to ask how the FDA plans to answer questions as to whether the product is a medical device and what level of regulation they plan for specific products.

“[The] FDA’s current guidance does not provide answers to basic questions about digital health products used with pharmaceuticals, including under what circumstances the software and the wearables might constitute medical devices, and under what circumstances, if they are medical devices, the marketing of these products might trigger combination product status,” wrote the CDS coalition. “Relying on basic principles from the existing statutes and regulations does allow developers to piece together answers for simple scenarios. For more complex areas, however, FDA has offered no guidance.”