On September 27, 2023, FDA issued a final guidance titled Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions.
This summer, the U.S. Food and Drug Administration (FDA) issued draft guidance regarding patient-matched guides to orthopedic implants, which are intended to assist in.
This digest covers key virtual and digital health regulatory and public policy developments during June 2023 from the United States, United Kingdom, and European Union.