thought leadership

FDA North America

August 17, 2022

Hydrogen Peroxide-Based Contact Lens Care Products: Consumer Labeling Recommendations - Premarket Notification (510(k)) Submissions

Draft Guidance for Industry and Food and Drug Administration Staff AUGUST 2022 FDA is issuing this draft guidance to provide labeling recommendations for hydrogen peroxide-based contact lens care...

Medical Device PDP

August 15, 2022

FDA Pathways to Medical Device Approval

FDA Pathways to Medical Device Approval: Commercializing your medical device in the US market often requires submitting a marketing application to the FDA to become an FDA Approved or Cleared Medical...

FDA North America

June 21, 2022

Non-Clinical Performance Assessment of Tissue Containment Systems Used During Power Morcellation Procedures

June 2022 Draft Guidance for Industry and Food and Drug Administration Staff Introduction This draft guidance document provides recommendations that may help manufacturers comply with the special...