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Certain Ophthalmic Products: Policy Regarding …
- https://www.fda.gov/regulatory-information/search-fda-guidance-documents/certain-ophthalmic-products-policy-regarding-compliance-21-cfr-part-4-guidance-industry
- This guidance applies to products with pending applications, approved products, and products marketed pursuant to section 505G of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C ...
Ophthalmic Devices Panel | FDA - U.S. Food and Drug …
- https://www.fda.gov/advisory-committees/medical-devices-advisory-committee/ophthalmic-devices-panel
- Charter Medical Devices Advisory Committee. The Ophthalmic Devices Panel (ODP) reviews and evaluates data concerning the safety and effectiveness of …
Learn more about Ophthalmic Medical Devices | BSI America
- https://www.bsigroup.com/en-US/medical-devices/Technologies/Ophthalmic-devices/
- As a manufacturer of an ophthalmic medical device, you must ensure that you meet the relevant regulatory requirements before placing your product onto the market; for the EU, …
Recognized Consensus Standards
- https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfstandards/detail.cfm?standard__identification_no=37073
- Endotoxin Testing Recommendations for Single-Use Intraocular Ophthalmic Devices - Guidance for Industry and Food and Drug Administration Staff, Issued August …
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