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For the evaluation of health supply registrations, Mexico’s Federal Commission for Protection of Sanitary Risks (COFEPRIS) released a new agreement for the equivalency requirements established in articles 167, 170, 177, 177 Bis 2, 179 and 180 of the Health Supplies Regulations and the technical evaluation procedures performed by COFEPRIS. In these cases, the COFEPRIS review is abbreviated.Equiva..

This guidance provides performance criteria for non-spinal metallic bone screws and their associated washers in support of the Safety and Performance Based Pathway. Under this framework, submitters planning to submit a 510(k) using the Safety and Performance Based Pathway for non-spinal metallic bone screws and washers will have the option to use the performance criteria proposed in this guidanc..

This guidance document provides the FDA’s recommendations on performance criteria to support premarket submissions for endosseous dental implants and abutments in the Safety and Performance Based Pathway. Under this framework, submitters planning to submit a 510(k) using the Safety and Performance Based Pathway for endosseous dental implants and abutments will have the option to use the performa..