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Safety and Effectiveness of the Platinum 330 System for Corneal Collagen CrossLinking in Eyes with Corneal Thinning ConditionsPROTOCOL NUMBER:1005312DATE:05/28/2019Sponsor:Balamurali K. Amati, MD,
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Safety and effectiveness refer to the extent to which a product or service achieves its intended purpose without causing harm.
Manufacturers, distributors, and sellers are typically required to file safety and effectiveness reports for their products.
The safety and effectiveness report can usually be filled out online or in a physical form provided by the regulatory agency.
The purpose of safety and effectiveness reports is to ensure that products on the market meet required safety standards and are effective for their intended use.
Information such as test results, adverse reactions, usage instructions, and manufacturing processes must be reported on safety and effectiveness forms.
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