The U.S. Food and Drug Administration (FDA) recently issued a guidance outlining a regulation change affecting certain ophthalmic dispenser products. The new regulation will require certain products previously regulated as drugs to adhere to requirements applicable for drug-device combination products. The regulation change will apply to companies with pending applications, marketed products, and OTC monograph drugs.

The guidance follows the U.S. Court of Appeals’ ruling in the 2021 case of Genus versus FDA. FDA determined that, based on the case’s outcome, wording previously used to regulate certain ophthalmic products as drugs is now obsolete. The guidance is effective immediately.

Keep reading to learn which ophthalmic products are subject to new regulations and when FDA expects companies to become compliant.

Genus Versus FDA

On April 16, 2021, the U.S. Court of Appeals for the District of Columbia Circuit issued its decision in the case of Genus Medical Technologies LLC v. U.S. Food and Drug Administration. The court ruled that drugs should be regulated as drugs and devices as devices unless a product is considered a combination product. In keeping with the ruling, FDA determined that it can no longer regulate eye cups, eye droppers, and other dispensers intended for ophthalmic use (ophthalmic dispensers) as drugs, but must regulate them as combination drug-device products.

FDA had previously regulated packages that contain both an ophthalmic device and the drug that is intended to be dispensed by the device as drugs. This was specific to ophthalmic products, as FDA regulated other such packages as combination products.

The guidance that corresponds to the new regulations indicates that, if an ophthalmic dispenser meets the definition of “device”, it is regulated as a device constituent part and subject to all applicable requirements: “Therefore, FDA intends to regulate these products as drug-led combination products composed of a drug constituent part that provides the primary mode of action and a device constituent part (an ophthalmic dispenser). Because the drug constituent part provides the primary mode of action, generally the Center for Drug Evaluation and Research (CDER) will have primary jurisdiction over these products.”

FDA’s Intent to Enforce the Regulations

Firms producing ophthalmic dispenser products with pending applications will need to submit certain information to FDA to meet the new regulations. Information FDA will require varies based on the product’s risk profile, submitted application information, and application type.

Some firms that were only implementing Current Good Manufacturing Practices (CGMPs) for certain ophthalmic products will need to demonstrate compliance with Quality System (QS) requirements during the application process. In this case, FDA may request documentation prior to the product’s approval. FDA may also request documentation during the facility inspection after the product’s approval. The guidance noted that FDA may request documentation during a pre-approval inspection, but this scenario is less likely.

FDA does not intend to take action against ophthalmic product companies subject to the new drug-device combination regulations within 12 months of the guidance’s release. In that time period, applicants and manufacturers need to develop and implement the policies and procedures necessary to comply with all applicable requirements. FDA may take enforcement action against firms not in compliance with the requirements after the 12-month period.

Although the guidance was effective immediately, it is open to public comments, which FDA will consider when deciding if revisions are needed.