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Sec. 820.1e Scope |
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(e) Exemptions
or variances. (1) Any person who wishes to petition for an exemption or
variance from any device quality system requirement is subject to the
requirements of section 520(f)(2) of the act. Petitions for an exemption or
variance shall be submitted according to the procedures set forth in § 10.30
of this chapter, the FDA`s administrative procedures. Guidance is available
from the Center for Devices and Radiological Health, Division of Small
Manufacturers Assistance (HFZ-220), 1350 Piccard Dr., Rockville, MD 20850,
U.S.A., telephone 1-800-638-2041 or 1-301-443-6597, FAX 301-443-8818. Interpretation:
It’s rare, but if you would like to be considered for an exemption or variance the FDA is willing to listen. One area where it would be likely to apply is where specific information is given for a particular device. In the case of a device you may ask to have the FDA consider a lower classification.
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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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