The Dec. 12, 2019, U.S. FDA warning letter to Curewave Lasers LLC, of Dallas, cited the company for claims for two of the company’s devices that are not part of the cleared indications for use. The agency said the Curewave laser was promoted as an alternative to surgery and as a treatment providing “enhanced nerve function.” The FDA said the company’s quality system lacked adequate design control procedures and adequate procedures for acceptance of incoming product, and that Curewave had not implemented a vendor assessment procedure. The company did not respond to contact for comment.
The U.S. Department of Health and Human Services said its response to the 2019-nCoV coronavirus emergency includes a request for submissions for federal funding for a diagnostic for the pathogen. HHS has opened an Easy Broad Agency Announcement (EZ-BAA) to allow the Biomedical Advanced Research and Development Authority (BARDA) office to accept and review “concise abstract submissions” for tests, which must utilize platforms already cleared by the FDA. Respondents’ plans must include a time frame for deployment of a diagnostic of no longer than 12 weeks.