Khemraj Hirani, Mylarrao Bansinath, Rahul Mittal, Joana R N Lemos, Emily Adis, Priyanka Poojari, Jane Margaret Igoe, Marcio R Soares, Sanjoy Bhattacharya, Roy E Weiss
The dynamic and continuously evolving field of ophthalmology necessitates rigorous regulatory oversight in the United States. This review outlines the multifaceted Food and Drug Administration's (FDA) approval process for ophthalmic products, detailing the classifications, pathways, and regulatory compliance for devices, drugs, biologics, and combination products. Particular emphasis is placed on distinct frameworks for Class I, II, and III devices, as well as regulations for drugs, biologics, and combination products...
October 5, 2023: Journal of Ocular Pharmacology and Therapeutics