The FDA finalized three guidance documents related to de novo classification requests for clearance when there is no predicate device for comparison.
The FDA issued a warning letter to Polymer Technology Systems — doing business as PTS Diagnostics — arising from an inspection earlier this year of its facility in Indianapolis.
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.
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.
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