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RGP contact lenses

This article was originally published in The Gray Sheet

Executive Summary

Manufacturers of Class III rigid gas permeable lenses may add lens finishing labs to approved PMAs without having to submit a PMA supplement provided the firm gets FDA approval of a protocol for handling the process, according to a guidance document recently released on the device center's website (www.fda.gov/cdrh). Instead of filing a supplemental application, firms must provide certain documentation in their annual reports and device master records and complaint files

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