The agency found several violations during an inspection related to its investigation of inaccurate blood lead test results.
The Class I recall is a result of a mold overflow defect that could obstruct blood flow.
Failing to report serious patient injuries will win you a warning letter.
SNITEM & Philips France vs. Health Minister: the ECJ defines the conditions under which software for assistance to the medical prescription can be qualified medical device within the meaning of the Directive.
The program intends to promote quality in medical device design and manufacturing.
The agency has issued its list of the most common inspectional observations for FY 2017.
FDA expects all installation activities to be documented.
While Western countries still have more medical device startups than the rest of the world, more new medtech startups are popping up in Asia than ever before.
Priorities include unique device identification and next-generation sequencing for in vitro diagnostics.
New virtual and in-person workshops will bring together FDA and industry experts and stakeholders on a variety of key issues.