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The FDA is introducing a new, voluntary program for certain medical devices and device-led combination products that are expected to significantly improve the safety of treatments for a disease or condition deemed less serious than those eligible for the breakthrough devices program. Read More
Under the FDA’s MDUFA IV commitments, the agency is developing electronic submission templates for device sponsors, but it says it’s “not feasible to describe and implement the electronic formats that would apply to all submissions in a single guidance,” in a draft guidance released last week. Read More
The FDA laid out its latest thinking on digital health tools in a package of six guidances released last week, highlighting the continued need for innovation. Read More
Lusys Laboratories: A 16-item Form 483 highlighted a litany of QMS lapses uncovered at Lusys Laboratories’ San Diego, California plant during a Jan. 22-Feb. 7 FDA inspection. Read More
As part of its ongoing overhaul of the 510(k) process, CDRH released finalized guidances on its special 510(k) and abbreviated 510(k) programs, on its refuse-to-accept policy for 510(k)s and on formatting recommendations for submissions. Read More
The FDA finalized three guidance documents related to de novo classification requests for clearance when there is no predicate device for comparison. Read More
The FDA cited four devicemakers for problems with their complaint procedures, change controls and quality oversight, among other deficiencies. Read More
The FDA rapped three devicemakers for a variety of violations including complaint handling, validations and failure to establish procedures for process changes. Read More
The FDA issued a final rule on appealing CDRH’s significant decisions about medical devices, including procedures for submitting requests and timelines for the agency’s responses. Read More
The FDA cited Carol Cole Company for failure to submit timely medical device reports of its devices that use microcurrents to tone, firm and reduce wrinkles, according to a Form 483 that was issued following a March 20-22 inspection of the firm’s Vista, Calif. facility. Read More
Process validation failures, documentation lapses and failure to establish corrective and preventive actions were just a few of the quality lapses found during a March 15-19 inspection of International Hospital Products’ Littleton, Colorado facility. Read More