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A French firm's failure to translate its 483 response letter and supporting documents into English prior to submitting them to the FDA may have lead to an avoidable warning letter.
The FDA is calling for a regulatory meeting with Respironics to determine why the Carlsbad, Calif.-based manufacturer repeatedly failed to submit medical device reports (MDRs) in connection with defective check valves on its Espirit ventilator.
The FDA is withholding final approval of Staar Surgical’s premarket approval application (PMA) for its implantable contact lens (ICL) while the company implements better procedures for filing medical device reports (MDRs).