SPADA Docs

submission program in which they can submit requests for FDA feedback on any concerns (e.g., 811 clinical trial design) or to discuss specifics that may pertain to the appropriate regulatory 812 pathway for their device (40). As a rule, early discussions such as those through the pre- 813 submission feedback mechanism facilitate agreement on items such as appropriate validation 814 studies to support Intended Use claims, and additional transparency in the pre-market review 815 process. 818 The Medical Device Amendments (MDA) (Pub. L. 94-295) to the Federal FD&C Act (enacted in 819 1976) directed FDA to issue regulations that classify all devices that were in commercial 820 distribution at that time into one of three regulatory control categories: Class I, II, or III, 821 depending upon the degree of regulation necessary to provide reasonable assurance of their 822 safety and effectiveness. The class into which a device is placed determines the requirements that 823 a medical device manufacturer must meet prior to distributing a device in interstate commerce. 824 According to section 513(a)(1) of the FD&C Act (21 U.S.C. § 360c(a)(1)), the following are 825 defined as the device classes: 816 817 7.2.1 Device Classification

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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 830 reasonable assurance of the safety and effectiveness of the device, but for which there is 831 sufficient information to establish special controls to provide such assurance. 832

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