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| | 21 CFR Part 820 |
 | | This Part 820 is established and promulgated under authority of sections 501, 502, 518, 519, 520(f), and 701(a) of the act (21 U.S.C. 351, 352, 360h, 360i, 360j(f) and 371(a)). |
 | | The failure to comply with any applicable provisions in Part 820 in the manufacture, packing, storage, or installation of a device renders the device adulterated under section 501(h) of the act. |
 | | The provisions of Part 820 shall be applicable to any finished device, as defined in this part, intended for human use, that is manufactured, imported, or offered for import in any State or territory of the United States, the District of Columbia, or the Commonwealth of Puerto Rico. |
| users.wpi.edu /~mleal/regulations/oldpart820.html (4560 words) |
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