FDA Qualifies Apple Watch AFib History Feature as a New Medical Device Development Tools

Anvisa Published A Regulation About Clinical Investigation For Medical Devices

On May 1, 2024, the FDA made a significant announcement by qualifying the Apple Watch AFib History Feature as a biomarker test device through its Medical Device Development Tools (MDDT) program.

The AFib history feature, now cleared by the FDA, is a commercially available over-the-counter (OTC) software-only mobile medical application intended for users 22 years of age and older who have a diagnosis of atrial fibrillation (AFib). This innovative feature aims to:

– Aid in better understanding the AFib burden in patients

– Provide supplemental data to more clinically well-defined endpoints

Impact for Patients and Healthcare Providers:

  • Enhanced Patient Monitoring: The AFib history feature on the Apple Watch helps patients and healthcare providers better monitor and understand the burden of AFib.
  • Supplemental Clinical Data: The feature provides valuable data that supplements traditional clinical endpoints, potentially improving patient outcomes and treatment strategies.

Next Steps for Medical Device Sponsors:

Medical device sponsors can now include the AFib history feature in their regulatory submissions by referencing the qualified MDDT submission number in the cover letter or the FDA CDRH Premarket Review Submission Cover Sheet form 3514.


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