Devicemakers should note whether changes to premarket approval devices were due to enhancement, product complaints or adverse events when preparing their annual reports to the U.S. Food and Drug Administration, according to guidance issued Feb. 10. Read More

Medtech companies that make modest improvements to their products will, in most cases, not need to file a new 510(k) with the U.S. Food and Drug Administration, a Feb. 25 report to Congress says. Read More

Devicemakers planning a premarket approval application or product development protocol should take advantage of presubmission meetings with the U.S. Food and Drug Administration to pin down exactly what data the agency expects to support safety and efficacy of a new product. Read More

China’s State Council last month approved the Medical Device Regulations (Amendment Bill), framework, paving the way for broad changes in device classification, adverse event reporting and monitoring of quality in device manufacturing. Read More

Manufacturers of diagnostics designated for research or investigational use only should limit their use to the earliest stages of device development, Alberto Gutierrez, director of CDRH’s Office of In Vitro Diagnostics and Radiological Health, said during a Wednesday webinar sponsored by the American Association for Clinical Chemistry. Read More

Devicemakers that make modest improvements to their products will, in most cases, not need to file a new 510(k), the FDA says in a report released to Congress on Tuesday. Read More