Recognizing that the future is now, drug and device companies are joining with health care providers and software/IT manufacturers in clamoring for a new kind of FDA guidance to clarify the regulatory path for treatment systems that combine digital health products with drugs.
Rather than just drugs in isolation, the emerging new treatment model is based on systems consisting of many components, including software, wearable devices, sensors and drugs, the Clinical Decision Support Coalition said in a citizen petition to the FDA. Such systems can advance personalized medicine by enhancing adherence to treatment regimens, better managing disease and putting up-to-date clinical guidelines at a doctor's fingertips.
Despite the advances digital health products offer, there is little guidance to direct their development and review, especially in conjunction with drugs. The uncertainty in the absence of guidance "results in viable, technically