SPADA Draft Documents

studies to support Intended Use claims, and additional transparency in the pre-market review 755 process.

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Device Classification 758 The Medical Device Amendments (MDA) (Pub. L. 94-295) to the Federal FD&C Act (enacted in 759 1976) directed FDA to issue regulations that classify all devices that were in commercial 760 distribution at that time into one of three regulatory control categories: Class I, II, or III, 761 depending upon the degree of regulation necessary to provide reasonable assurance of their 762 safety and effectiveness. The class into which a device is placed determines the requirements that 763 a medical device manufacturer must meet prior to distributing a device in interstate commerce. 764 According to section 513(a)(1) of the FD&C Act (21 U.S.C. § 360c(a)(1)), the following are 765 defined as the device classes:

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( a ) Class I .—Devices are subject to a comprehensive set of regulatory authorities called

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general controls that are applicable to all classes of devices.

( b ) Class II .—Devices for which general controls, by themselves, are insufficient to provide 770 reasonable assurance of the safety and effectiveness of the device, but for which there is 771 sufficient information to establish special controls to provide such assurance. 772 ( c ) Class III .—Device for which general controls, by themselves, are insufficient and for 773 which there is insufficient information to establish special controls to provide reasonable 774 assurance of the safety and effectiveness of the device. Class III devices typically require 775 premarket approval.

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