The FDA is telling Health Science Products to get certification from an outside expert, after the company purchased components from unqualified suppliers. Read More

A Puerto Rican company’s recall of sterile convenience surgical packs may be the largest one-day device recall in FDA history. Read More

With 12 recalls in less than 36 months, Johnson & Johnson tops the list of the five medical devicemakers with the most Class I recalls between 2012 and the present, according to FDA data. Read More

Manufacturers of medical devices that contain nanomaterials should use a phased approach to evaluate risk to avoid unnecessary testing, an expert committee of the European Commission recommends. Read More

Acme Monaco received an FDA warning letter for failures related to design validation, process validation and other GMP issues. Read More

As 3D printing gains popularity among medical devicemakers, the FDA wants to get advice from manufacturers and researchers to guide its product reviews and, possibly, future guidance. Read More

CooperVision’s Puerto Rico facility has received an FDA warning letter for inadequate investigations into nonconformities and other GMP issues. Read More

CINCINNATI — CDRH’s Office of Compliance expects to begin work on a public database of device quality information, such as MDR reports, by the end of the year, OC Director Steven Silverman told devicemakers May 7 at the FDA/Xavier University MedCon conference. Read More