Drugs

FDA Ophthalmic Product Guidance Mandated by Court

FDA has published an immediately-in-effect guidance, Certain Ophthalmic Products: Regarding Compliance with 21 CFR Part 4, with information on compliance with the regulatory requirements for ophthalmic drugs packaged with eyecups, eye droppers, or other dispensers. The document says FDA was issuing it without advance time for comments because a federal court decision in Genus requires it to communicate its policy promptly.

“Although the guidance is immediately in effect,” the agency says, “FDA will consider all comments received and determine whether revisions to the guidance document are appropriate.”

In a 4/16/21 decision involving Genus Medical Technologies, the DC Circuit Court of Appeals affirmed a lower court determination that FDA does not have discretion when a combination product meets the definition of both a device and a drug. At the time, attorneys representing Genus said it was a “big win” for industry. “This decision limits FDA’s typically broad discretion and precludes the agency from imposing significant regulatory hurdles and costs based on policy positions rather than the congressionally-imposed risk-based regulatory scheme,” they said. “In other words, FDA cannot regulate a device as a drug on a whim.”

In the guidance, the agency explains that before the Genus decision, ophthalmic dispensers packaged together with the ophthalmic drug with which they were intended to be used were regulated as drugs. Following the decision, however, an ophthalmic dispenser that meets the regulatory definition of a device and is packaged with an ophthalmic drug is now regulated as a device constituent part. “This change impacts products subject to pending applications, approved products, and OTC monograph drugs,” FDA says.

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome