FDA delays UDI rule for contacts, intraocular lenses

The FDA gives Class III contact and intraocular lens manufacturers a 1-year extension to comply with the Unique Device Identifier program.

Makers of contact lenses and intraocular lenses are getting a 1-year reprieve after the FDA agreed to shift their due date for complying with Unique Device Identifier rules.

Manufacturers successfully lobbied for a delay after demonstrating that requirements for lenses would create a massive burden for both device makers and regulators.

Food & Drug Administration (FDA)

News Well, Food & Drug Administration (FDA), Optical/Ophthalmic, Regulatory/Compliance, Universal Device Identifier (UDI)

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