Source: http://www.law.cornell.edu/cfr/text/21/1010.2
Timestamp: 2014-12-18 23:22:22
Document Index: 282604310

Matched Legal Cases: ['art 1010', '§ 1010', '§ 351', '§ 352', '§ 360', '§ 360', '§ 221', '§ 360', '§ 360', '§ 360', '§ 360', '§ 360', '§ 360', '§ 360', '§ 360', '§ 360', '§ 360', '§ 360', '§ 360', '§ 360', '§ 360', '§ 360', '§ 371', '§ 381']

21 CFR 1010.2 - Certification. | LII / Legal Information Institute
CFR › Title 21 › Chapter I › Subchapter J › Part 1010 › Subpart A › Section 1010.2 21 CFR 1010.2 - Certification.
§ 1010.2
Every manufacturer of an electronic product for which an applicable standard is in effect under this subchapter shall furnish to the dealer or distributor, at the time of delivery of such product, the certification that such product conforms to all applicable standards under this subchapter.
The certification shall be in the form of a label or tag permanently affixed to or inscribed on such product so as to be legible and readily accessible to view when the product is fully assembled for use, unless the applicable standard prescribes some other manner of certification. All such labels or tags shall be in the English language.
Such certification shall be based upon a test, in accordance with the standard, of the individual article to which it is attached or upon a testing program which is in accordance with good manufacturing practices. The Director, Center for Devices and Radiological Health may disapprove such a testing program on the grounds that it does not assure the adequacy of safeguards against hazardous electronic product radiation or that it does not assure that electronic products comply with the standards prescribed under this subchapter.
In the case of products for which it is not feasible to certify in accordance with paragraph (b) of this section, upon application by the manufacturer, the Director, Center for Devices and Radiological Health may approve an alternate means by which such certification may be provided.
This is a list of United States Code sections, Statutes at Large, Public Laws, and Presidential Documents, which provide rulemaking authority for this CFR Part.This list is taken from the Parallel Table of Authorities and Rules provided by GPO [Government Printing Office].It is not guaranteed to be accurate or up-to-date, though we do refresh the database weekly. More limitations on accuracy are described at the GPO site.United States CodeU.S. Code: Title 21 - FOOD AND DRUGS§ 351 - Adulterated drugs and devices§ 352 - Misbranded drugs and devices§ 360 - Registration of producers of drugs or devices§ 360e - Premarket approval21 U.S. Code § 221 to 237 - Repealed. July 1, 1944, ch. 373, title XIII,§ 360f - Banned devices§ 360g - Judicial review§ 360h - Notification and other remedies§ 360i - Records and reports on devices§ 360j - General provisions respecting control of devices intended for human use§ 360hh - Definitions§ 360ii - Program of control§ 360jj - Studies by Secretary§ 360kk - Performance standards for electronic products21 U.S. Code § -§ 360mm - Imports§ 360nn - Inspection, records, and reports21 U.S. Code § -§ 360pp - Enforcement§ 360qq - Repealed.§ 360rr - Federal-State cooperation§ 360ss - State standards§ 371 - Regulations and hearings§ 381 - Imports and exports