The U.S. FDA said it had issued warning letters to two makers of breast implants due to the companies’ failure to comply with postmarket approval orders under Section 522 of the Food, Drug and Cosmetic Act. The May 14 letter to Allergan, of Irvine, Calif., said the company’s studies for the Natrelle series of implants lacked sufficient office visits for enrollee follow-up to satisfy the terms of the postapproval study agreement, and that the closure of several study sites suggests that there will be insufficient enrollees at the end of the study. The May 14 warning letter to Ideal Implant Inc., of Dallas, said the company’s procedures failed to direct the handling of canceled complaints, and that Ideal had failed to document corrective action undertaken in connection with sterilization failures.
The FDA said it has issued an emergency use authorization (EUA) category for infusion pumps in response to the COVID-19 pandemic due to concerns that supplies of pumps and pump accessories are currently inadequate to meet demand. The new policy would seem to overwrite an April 2020 guidance that provided some leniency regarding device modifications for infusion pumps, the scope of which covered four product codes for pumps and numerous codes for accessories. The EUA covers the same pump procodes (FRN, MEA, MRZ, and PHC) as the April guidance, although the list of accessory procodes is shorter in the EUA policy, excluding previously included procodes, such as MAJ for short-term intraspinal catheters. The agency said it will add procodes to the EUA policy upon request, assuming the criteria for inclusion are met. Among the criteria is device conformity with a number of international performance standards, such as the IEC 60601 series for electrical equipment safety and performance, and seven entries under the ISO series of standards, including the 1986 iteration of ISO 594-1 for general requirements for syringes and needles.
The U.S. Department of Justice said Qing Wang, formerly an employee of the Cleveland Clinic Foundation, has been charged with false claims and wire fraud in connection with $3.6 million in NIH funding he and his research office received despite his affiliation with a university in China. The complaint states that Wang held the position of dean of the College of Life Sciences and Technology at the Huazhong University of Science and Technology in Wuhan, China, where he received grants for research that overlapped with the focus of NIH grants he had received. Wang also is alleged to have taken part in the Thousand Talents Program (TTP), which was designed to recruit individuals who had knowledge of or access to technology or intellectual property developed outside China. Wang is said to have received $3 million for his acceptance into the TTP but failed to disclose these activities upon receipt of NIH grant money.