Draft LASIK Guidance: Why Did FDA Issue New Labeling Recommendations for Products that Already Have PMA Approved Labeling?
FDA Law Blog
DECEMBER 12, 2022
intrusion [into] the doctor-patient relationship. Shapiro — Last summer, FDA published a draft guidance, Laser-Assisted In Situ Keratomileusis (LASIK) Lasers – Patient Labeling Recommendations (July 29, 2022) setting forth a proposal for new recommended patient‑directed labeling. The draft guidance purports to apply to current PMA holders.
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