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Sec. 820.1c Scope. |
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(c) Authority.
Part 820 is established and issued under authority of sections 501, 502, 510,
513, 514, 515, 518, 519, 520, 522, 701, 704, 801, 803 of the act (21 U.S.C.
351, 352, 360, 360c, 360d, 360e, 360h, 360i, 360j, 360l, 371, 374, 381, 383).
The failure to comply with any applicable provision in this part renders a
device adulterated under section 501(h) of the act. Such a device, as well as
any person responsible for the failure to comply, is subject to regulatory action.
Interpretation:
The interesting point here is that the regulatory action is enforced not only to the device but also to “...to any person responsible for the failure to comply, ...
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Reference: www.FDA.gov The information provided here is for "public consumption" and is open to interpretation. MedicalDeviceSchool.com is not responsible for the content or the accuracy of the information. For all official interpretation and accuracy we ask that you consult the FDA's website directly and that you consult with your legal and regulatory experts on all matters of interpretation. |
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