The U.S. Justice Department announces that medical device manufacturer ev3 has agreed to plead guilty to introducing an adulterated medical device int...
FDA says CDRH is making progress on its strategic goal to facilitate development of collaborative communities.
FDA issues a proposed rule to change the submission and review requirements for the medical device de novo classification pathway.
FDA releases its latest batch of Warning Letters that include Barox Co., Globus Medical and MiBo Medical Group.
AdvaMed and other industry groups comment on FDAs recent draft guidance on The Special 510(k) Program, suggesting that the documents proposed text may...
FDA approves a Medifocus PMA supplement for new labeling for its Prolieve Transurethral ThermoDilatation Therapy based on the results from the company...
FDA posts a Form FDA-483 citing JCB Laboratories over GMP deficiencies at the drug outsourcing operation.
Federal Register notice: FDA seeks comments on an information collection extension entitled FDA Adverse Event Reports; Electronic Submissions.