Amendment to Include Respiratory Therapy Devices in the List of Medical Devices Covered by FDA Circular No. 2020-009, as Amended by FDA Circular No. 2020-009-A

April 29, 2020

FDA CIRCULAR NO. 009-B-20

 

The listing of health products enumerated under Section IV-Scope of FDA Circular No. 2020-009, as amended by FDA Circular No. 2020-009-A, entitled "Guidelines on the Identification, Notification, Evaluation, Regulatory Enforcement Action, and Review and Monitoring of Donated Health Products Solely Intended to Address COVID-19 Public Health Emergency is hereby amended to include "Respiratory Therapy Devices."

Therefore, the listing provided under said Section of the subject Circular shall be amended to read as follows: HTcADC

1. Face Masks including N-95 Masks,

2. Shoe Covers,

3. Gloves,

4. Head Covers,

5. Gowns,

6. Goggles/Face Shields,

7. COVID-19 Diagnostic Test Kits,

8. Alcohol, Hand Sanitizers, etc.,

9. Ventilators, Respirators, their respective Accessories, and Respiratory Therapy Devices,

10. Other health products that may hereinafter identified and listed by the FDA.

This issuance shall take effect immediately.

For your information and guidance.

(SGD.) ROLANDO ENRIQUE D. DOMINGO, MDDirector General