While CDRH defers a decision on a petition from former staffer Morris Waxler to withdraw the LASIK indication from ophthalmic laser approvals, injured LASIK patients yesterday sent commissioner Margaret Hamburg a 504-signatory petition in support and asking her to "carefully consider each signer's remarks."
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A seven-month-old citizen petition seeking a safety-based withdrawal of approval for all LASIK eye surgery devices "raises issues requiring further review and analysis by agency officials," according to a 7/7 letter to petitioner Morris Waxler, the former CDRH official who led the devices' review and approval. Signed by Center deputy director for policy Nancy Stade, the letter says FDA has so far been unable to reach a decision, and offers no indication of how long a decision might take.
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