CFR

860.95—Exemptions from sections 510, 519, and 520(f) of the act.

(a) A panel recommendation to the Commissioner that a device be classified or reclassified into class I will include a recommendation as to whether the device should be exempted from some or all of the requirements of one or more of the following sections of the act: Section 510 (registration, product listing and premarket notification), section 519 (records and reports), and section 520(f) (good manufacturing practice requirements of the quality system regulation).

(b) A regulation or an order classifying or reclassifying a device into class I will specify which requirements, if any, of sections 510, 519, and 520(f) of the act the device is to be exempted from, together with the reasons for such exemption.

(c) The Commissioner will grant exemptions under this section only if the Commissioner determines that the requirements from which the device is exempted are not necessary to provide reasonable assurance of the safety and effectiveness of the device.

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