Draft LASIK Guidance: Why Did FDA Issue New Labeling Recommendations for Products that Already Have PMA Approved Labeling?
FDA Law
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. FDA has already approved the patient labeling in connection with each individual manufacturer’s PMA approval.
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