Fda Section 510 J
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Fda section 510 j. The establishment is not registered with fda as required by section 510 of the ffdca and has not listed the device as required by section 510 j of the ffdca or obtained applicable premarket. To search the fd c act on the law revision counsel website you may either search by u s. Code section number or browse the title 21 section listing.
Laws enforced by fda federal food drug and cosmetic act fd c act. 510 fd c act section 510 corresponds to 21 usc section 360. 360b new animal drugs.
For purposes of this section a device defined in section 201 h of the federal food drug and cosmetic act that is intended for humans means a device that is listed as a device with the food and drug administration fda under section 510 j of the federal food drug and cosmetic act and 21 cfr part 807 pursuant to fda requirements. 510 301 records and reports concerning experience with animal feeds bearing or containing new animal drugs for which an approved medicated feed mill license application is in effect. Section 510 k of the food drug and cosmetic act requires device manufacturers who must register to notify fda of their intent to market a medical device at least 90 days in advance.
360 registration of producers of drugs or devices. The following classes of persons are exempt from registration in accordance with 807 20 under the provisions of section 510 g 1 g 2 and g 3 of the act or because the commissioner of food and drugs has found under section 510 g 5 of the act that such registration is not necessary for the protection of the public health. Part a drugs and devices sections 351 360n 1.
360d performance.
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