CLOSEOUT LETTER
WHOOP, Inc. MARCS-CMS 709755 —
- Product:
- Medical Devices
- Recipient:
-
Recipient NameWill Ahmed
-
Recipient TitleChief Executive Officer
- WHOOP, Inc.
One Kenmore Sq. Suite 601
Boston, MA 02215
United States
- Issuing Office:
- Center for Devices and Radiological Health
United States
United States
Dear Mr. Ahmed:
Based on changes your firm has made to your “Blood Pressure Insights” product (“BPI”) and its labeling in response to our Warning Letter dated July 14, 2025, and consistent with the Food and Drug Administration’s updated guidance document, General Wellness: Policy for Low Risk Devices,1 FDA does not intend to enforce the device statutory and regulatory requirements for your BPI product as modified.
We note that this letter is specific to your BPI product as modified and not to any other product, feature or other modifications to BPI. If you have any questions about future modifications to BPI, please contact Stephen Browning.
Sincerely,
/S/
Angela C. Krueger
Deputy Director for Regulatory Policy
Office of Product Evaluation and Quality
Center for Devices and Radiological Health
Food and Drug Administration
- 1This guidance describes a policy where FDA does not intend to examine low risk general wellness products to determine whether they are devices within the meaning of the FD&C Act or, if they are devices, whether they comply with the premarket review and various post-market requirements for devices under the FD&C Act. FDA issued updates to this guidance on January 6, 2026.