Firm Warned by FDA Says It’s No Device Maker

Care Tech Industries, which recently received an FDA warning letter, claims it does not manufacture medical devices and should not be treated as a devicemaker. When the FDA first told the company its recirculating air cleaners are medical devices, Care Tech said it requested a classification change from a medical device to an air purifier, which would have exempted it from 510(k) requirements. “Not hearing from FDA for two-and-a-half years, we assumed all was well,” company President John Shannon said. However, according to the warning letter, the FDA has a different story. It said when the firm submitted a request in 2005 for information on the status of its devices as well as its classification and regulatory requirements, the agency told it the devices are Class II, requiring a premarket notification submission and agency clearance prior to marketing. Care Tech submitted a response disagreeing with the Class II classification, but the agency said it reiterated that the Odatus air cleaner is a Class II device and the firm would need 510(k) clearance prior to marketing. After this exchange, Care Tech did not communicate further or file a 510(k), the letter said. The labeling for the devices claimed the product can eliminate ebola, tuberculosis, Streptococcus, asthma attacks, allergies, infections, fatigue, depression, viruses, respiratory and eye infections, lung damage and brain damage, the letter said. Therefore, the products are medical devices and are misbranded. Shannon said the company’s issues began with a California crackdown on certain medical devices and that his product is no longer allowed to be sold there. The Care Tech warning letter can be seen at www.fda.gov/foi/warning_letters/s6636c.pdf. SOURCE: FDAnews