The Food and Drug Administration (FDA) informs all healthcare professionals and the general public that the medical device product, SM Bonus Underpads, has been issued an FDA Certificate of Medical Device Notification to the Market Authorization Holder (MAH), Uni-care Hygienic Products, Inc., 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. 2022-1673 dated 29 September 2022 is hereby lifted.
The public health warning imposed on the remaining product listed in FDA Advisory No. 2022-1637 shall remain to be upheld and shall not be affected by the issuance of this advisory. Furthermore, 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 the 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 unnotified medical device, contact the online reporting facility, eReport, through e-mail at [email protected].
Dissemination of this advisory to all concerned is hereby requested.