Draft LASIK Guidance: Why Did FDA Issue New Labeling Recommendations for Products that Already Have PMA Approved Labeling?
FDA Law Blog
DECEMBER 12, 2022
There appears to be significant overlap in content between the Checklist and informed consent forms and processes routinely provided by healthcare providers to their patients. intrusion [into] the doctor-patient relationship. This proposal is a[n]. Therefore, it is likely that this guidance is really directed at existing PMA holders.
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