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:
- Face Masks including N-95 Masks,
- Shoe Covers,
- Head Covers,
- Goggles/ Face Shields,
- COVID-19 Diagnostic Test Kits,
- Alcohol, Hand Sanitizers, etc.
- Ventilators, Respirators, their respective Accessories, and Respiratory Therapy Devices
- Other health products that may hereinafter identified and listed by the FDA.
This issuance shall take effect immediately.
For your information and guidance.
Attachment:->FDA Circular No.2020-009-B