09.04.25 -- Staying Ahead of Enforcement: Executive Strategies To Prevent FDA Warning Letters

The medical device industry is familiar with quality audits, but is less familiar with the benefits of having a cultural audit to assess the competence, dedication, and passion that each party brings to the table.

The FDA’s draft guidance defines Essential Drug Delivery Output (EDDO) requirements, outlining expectations for submissions, which should now align with the agency’s latest recommendations.

Ophthalmic medical device safety relies on regulatory compliance, rigorous risk management, and thorough testing, ensuring quality, patient safety, and effective vision care worldwide.