CPC Comments on FDA’s Draft Guidance “Digital Health Technologies for Remote Data Acquisition in Clinical Investigations”

On March 22, 2022, the CPC submitted a letter to FDA regarding the agency’s draft guidance addressing “Digital Health Technologies for Remote Data Acquisition in Clinical Investigations,” which will establish FDA’s expectations of the types of evidence required to support use of digital health technologies for remote data acquisition in clinical investigations. While CPC greatly appreciates FDA’s efforts to provide this draft guidance for comment, CPC’s comments highlight certain areas of concern for FDA to consider as it finalizes the guidance.