21 CFR 1010.2 - Certification.

§ 1010.2 Certification.

(a) 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.

(b) 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.

(c) 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.

(d) 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.

[ 38 FR 28631, Oct. 15, 1973, as amended at 40 FR 32257, July 31, 1975; 42 FR 18063, Apr. 5, 1977; 53 FR 11254, Apr. 6, 1988]

Title 21 published on 10-May-2017 03:43

The following are ALL rules, proposed rules, and notices (chronologically) published in the Federal Register relating to 21 CFR Part 1010 after this date.

  • 2013-06-24; vol. 78 # 121 - Monday, June 24, 2013
    1. 78 FR 37723 - Laser Products; Proposed Amendment to Performance Standard
      GPO FDSys XML | Text
      DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration
      Proposed rule.
      Submit either electronic or written comments on the proposed rule by September 23, 2013. Submit comments on information collection issues under the Paperwork Reduction Act of 1995 by July 24, 2013 (see section VIII, the “Paperwork Reduction Act of 1995” section of this document). See section IV of this document for the proposed effective date of a final rule based on this proposed rule.
      21 CFR Parts 1002, 1010, and 1040