FDA WARNING_LETTER - Mectra Labs, Inc.

The FDA issued a Warning Letter to Mectra Labs Inc. for marketing Electro-Lube, Magnified Insufflation Needle (MAGI), and A Lighted Insufflation Endoscopic Needle (ALIEN) devices without proper marketing clearance or approval. The FDA's review of the firm's website revealed that the MAGI and ALIEN devices are adulterated under 21 U.S.C. § 351(f)(1)(B) due to the lack of an approved PMA or IDE. They are also misbranded under 21 U.S.C. § 352(o) and 21 CFR 807.81(a)(3)(i) because the firm failed to notify the agency of significant modifications, including the addition of a 75mm needle and a change in the user interface to LED lights, which deviate from cleared specifications and raise safety concerns. Similarly, the Electro-Lube device is adulterated for lacking PMA/IDE approval and misbranded under 21 U.S.C. § 352(o) and 21 CFR 807.81(a)(3)(ii) for being promoted for new intended uses (e.g., robotic instruments, various surgical applications) without a required 510(k) notification. Mectra Labs is instructed to immediately cease activities leading to the misbranding or adulteration of these devices. The firm must provide a written response within fifteen business days detailing corrective actions, preventative measures, and a timeline for completion. Failure to comply may result in regulatory actions such as seizure, injunction, civil money penalties, and impact on federal contracts.