Eye Drops Will Be Regulated by FDA as Drug-Device Combinations

Eye drops and other ophthalmic drugs long regulated by the FDA as drugs will soon be considered drug-device combination products, according to final guidance released Tuesday.

The Food and Drug Administration said the change will apply to pending applications, approved ophthalmic products, and over-the-counter drugs. The guidance is part of the agency’s ongoing efforts to revisit regulations for drug-device combination products—a process that industry trade groups and some attorneys have said will create unnecessary work for companies to comply with new sets of requirements.

The agency said the decision brings regulations for ophthalmic products in line with a 2021 appellate ...