The Food and Drug Administration (FDA) informs all healthcare professionals and general public that the medical device product i-shield GAUZE PAD sterilized (4” x 4” x 8 ply 28 x 24 mesh) has been registered by the Market Authorization Holder (MAH), Ishield Enterprise, in accordance to existing FDA rules and regulations.
Accordingly, the warning against the purchase and use of the product as mentioned in FDA Advisory No. 2020-1809 dated 05 October 2020 is hereby lifted.
The issuance of this advisory shall not in any manner preclude this Office from issuing subsequent orders it may deem necessary and appropriate, should there be findings of any violation of the company to existing laws, rules, and regulations.
For more information and inquiries, kindly contact the FDA Center for Device Regulation, Radiation Health, and Research through e-mail at [email protected] or call (02) 8857-1900 loc. 8301.
To report any sale or distribution of unregistered medical device products, the online reporting facility, eReport can be accessed at www.fda.gov.ph/ereport.
Dissemination of this advisory to all concerned is hereby requested.