FDA FAULTS COMPANY FOR LACKING APPROVED PMA APPLICATION
Rhein 83 must stop marketing its dental products in the U.S. because it lacks an approved premarket approval (PMA) application, an FDA warning letter said.
During inspections of the firm's plant in Bologna, Italy, June 19-22, an agency investigator found that Rhein 83's endosseous implant abutments and dental attachments were adulterated and misbranded, the Nov. 21 letter said. The letter was posted to the FDA website Dec. 5.
The company lacks an approved PMA application or an approved application for an investigational device exemption, the letter said. Also, Rhein 83's products are misbranded because the company did not notify the agency of its intent to commercially distribute its devices.
The company responded to the FDA's Form 483, but the response was inadequate because the attachments and other supporting documents were not in English, according to the warning letter.
The warning letter faulted Rhein 83 for changing its devices after the clearance of its 510(k). The changes require a new premarket notification submission because they could affect the safety or effectiveness of the devices, the letter said.