The Food and Drug Administration (FDA) informs all healthcare professionals and the general public that the medical device product, Unnotified Mr. DIY Reading Glass, has been issued an FDA Certificate of Medical Device Notification (CMDN) to the Market Authorization Holder (MAH), Bricolage Philippines Inc., in accordance with existing FDA rules and regulations.
Accordingly, the warning against the purchase and use of the product as mentioned in FDA Advisory No. 2022-1909 dated 16 December 2022 is hereby lifted.
The public health warning imposed on the remaining products listed in FDA Advisory No. 2022-1909 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 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.