Description of Event or Problem · 0
SUBJECT: SUSPECTED UNREGISTERED FOREIGN MEDICAL DEVICE MANUFACTURER ¿ LABEX TRADE LTD. TO WHOM IT MAY CONCERN, I AM SUBMITTING THIS REPORT TO ALERT THE FDA TO A POTENTIAL VIOLATION OF ESTABLISHMENT REGISTRATION AND DEVICE LISTING REQUIREMENTS UNDER 21 CFR PART 807 BY A FOREIGN MANUFACTURER WHOSE PRODUCTS MAY BE COMMERCIALLY DISTRIBUTED IN THE UNITED STATES. COMPANY INFORMATION COMPANY NAME: (B)(4) PRODUCT LINE: ELECTRONIC LARYNX DEVICES (LABEX HARMONY, LABEX INSPIRATION, LABEX DIGITAL, ETC.) NATURE OF CONCERN LABEX TRADE LTD. ADVERTISES MULTIPLE MEDICAL DEVICES ON ITS WEBSITE THAT ARE CLASS I ELECTRONIC SPEECH AIDS (ELECTROLARYNX DEVICES). THESE DEVICES APPEAR TO BE AVAILABLE FOR INTERNATIONAL SHIPMENT, INCLUDING TO THE UNITED STATES. HOWEVER: A SEARCH OF THE FDA ESTABLISHMENT REGISTRATION & DEVICE LISTING DATABASE YIELDED NO ACTIVE RECORDS FOR LABEX TRADE LTD. THE COMPANY'S WEBSITE PRESENTS CE CERTIFICATES AND ISO 9001 COMPLIANCE, BUT NO MENTION OF FDA REGISTRATION, U.S. AGENT, OR LISTING CONFIRMATION. DEVICES ARE ADVERTISED IN ENGLISH AND PRICED IN USD, IMPLYING U.S. MARKET TARGETING. LABEX TRADE LTD. APPEARS TO BE MARKETING DEVICES DIRECT-TO-CONSUMER OR VIA ONLINE FULFILLMENT PLATFORMS, WHICH MAY CONSTITUTE COMMERCIAL DISTRIBUTION WITHIN THE MEANING OF 21 CFR §807.3(B). REGULATORY RISK IF LABEX TRADE LTD. IS MANUFACTURING AND OFFERING FOR SALE THESE CLASS I DEVICES IN THE U.S. WITHOUT: FDA ESTABLISHMENT REGISTRATION, FDA DEVICE LISTING, A DESIGNATED U.S. AGENT. IT MAY BE IN VIOLATION OF THE FEDERAL FOOD, DRUG, AND COSMETIC ACT, AND ITS PRODUCTS MAY BE MISBRANDED UNDER SECTION 502(O). REQUEST FOR REVIEW I RESPECTFULLY REQUEST THAT THE FDA ASSESS WHETHER LABEX TRADE LTD. IS CURRENTLY: DISTRIBUTING UNREGISTERED DEVICES IN THE UNITED STATES; FAILING TO COMPLY WITH APPLICABLE REQUIREMENTS FOR FOREIGN DEVICE MANUFACTURERS; OPERATING THROUGH THIRD-PARTY U.S. DISTRIBUTORS OR PLATFORMS WITHOUT DISCLOSURE. THIS SUBMISSION IS MADE IN GOOD FAITH FOR THE PROTECTION OF PUBLIC HEALTH AND REGULATORY INTEGRITY. SUBMITTED ANONYMOUSLY.