The Food and Drug Administration ordered a Canadian device manufacturer to stop marketing its device in the U.S. for unapproved uses, and renew its lapsed registration, in a warning letter dated March 13. According to FDA, Body, Mind & Soul, Inc. is marketing its “Celluderm,” a therapeutic massager, for uses as diverse as boosting the immune system, reduction of water retention, relief of headaches and restless legs, and breast cyst reduction. Marketing for new intended uses requires premarket notification to the agency. Without a premarket approval notification (PMA), its device is adulterated. The company did not complete a facility registration for 2013 either, FDA said.
On March 26 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:
The Food and Drug Administration posted two frequently asked questions documents on its Jan. 16 produce safety (here) and hazard analysis and preventative controls proposed rules (here) (see 13010805 and 13010429, respectively). The Food Safety Modernization will require importers to verify compliance with the final versions of these produce safety and preventative controls rules, as part of the Foreign Supplier Verification Program (FSVP).
On March 22 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:
The Food and Drug Administration amended a final rule to show a change of address for the Center for Devices and Radiological Health effective March 26. The new address is 10903 New Hampshire Ave., Silver Spring, MD 20993-0002. Designation of agent by manufacturers of electronic products for importation into the U.S. must be addressed to the Center for Devices and Radiological Health, Document Mail Center. The change isn't substantive, said the FDA.
The Food and Drug Administration is proposing to require premarket approval for automated external defibrillator (AED) systems. Should FDA finalize its proposed order, a pre-market approval (PMA) application or notice of development of product development protocol (PDP) will be required before commercial distribution of the class III devices. Comments on the proposed order are due by June 24.
On March 21 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:
On March 20 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:
The Food and Drug Administration issued its weekly Enforcement Report for March 20 that lists the status of recalls and field corrections for food, drugs, biologics, and devices. The report covers both domestic and foreign firms.
A Chinese beauty product manufacturer’s devices will be subject to refusal at the border for failure to register their product with FDA and violations of Medical Device Reporting regulations, said the Food and Drug Administration in a warning letter. According to FDA, Nanhai Meishida Beauty Equipment did not indicate that it had trained employees in MDR procedures. It also markets a “13 in 1 Beauty Instrument” with a “high-frequency function” that induces “sterilization and evaporation,” as well as “hyperemization,” among other things. The company didn’t get permission from FDA in the form of premarket approval or an investigational device exemption, FDA said.