Medical Device, Emerging Technology, Digital Health Research Quality, Safety, and Regulatory Compliance Expert
Premarket device regulations can be tricky for combination products, but involving regulators early and often prior to clinical trials will absolutely go a long way in clearing up any confusion. Regardless of whether a clinical study is conducted through a drug-led path, device-led path, or biologic-led path, each constituent part must still comply with its own set of reg requirements AND ALSO consider combined risks and requirements. Primary mode of action will dictate the primary path. An integral prefilled product may for instance be approved for trials through a drug path application, and still need to comply with certain elements of investigational devices (perhaps through abbr IDE requirements) in order to demonstrate the safe and effective performance of the device constituent with that drug and that target population. The fun never ends. https://lnkd.in/geqAiy-x