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CPC Letter to FDA Regarding the Use of Investigational Digital Medical Devices in Clinical Studies for Medicines

On August 3, 2021, the CPC submitted a letter to FDA proposing that the agency adopt a risk-based policy that would relax medical device Current Good Manufacturing Practice expectations for certain low-risk medical device digital technologies deployed into Investigational New Drug Application studies. CPC detailed the applicability of its proposal, risk criteria and categories, and information required to be disclosed under the proposal. CPC emphasized that “[b]y establishing a risk-based policy allowing study sponsors to apply state-of-the-art software development and validation approaches, [FDA] will greatly improve the pace at which pharmaceutical and combination products sponsors can deploy these technologies to the benefit of patients and investigators.”