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Beginning with the 1902 Biologics Act, however, government control has consistently enacted the anticipation approach by expanding premarket approval requirements. awesome review and set!? clexane 80mg inj. Today, drugs and medical devices must obtain premarket approval by the FDA before the product is allowed on the market. Devices categorized as Class III require premarket approval.

According to the 1976 Amendments, all new devices were automatically placed in Class III even if they were low-risk devices.

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