The provisions of this part are applicable as follows:
(a) All manufacturers of electronic products are subject to 1002.20.
(b) Manufacturers, dealers, and distributors of electronic products are subject to the provisions of part 1002 as set forth in table 1 of this section, unless excluded by paragraph (c) of this section, or unless an exemption has been granted under 1002.50 or 1002.51.
(c) The requirements of part 1002 as specified in table 1 of this section are not applicable to:
(1) Manufacturers of electronic products intended solely for export if such product is labeled or tagged to show that the product meets all the applicable requirements of the country to which such product is intended for export.
(2) Manufacturers of electronic products listed in table 1 of this section if such product is sold exclusively to other manufacturers for use as components of electronic products to be sold to purchasers, with the exception that the provisions are applicable to those manufacturers certifying components of diagnostic x-ray systems pursuant to provisions of 1020.30(c) of this chapter.
(3) Manufacturers of electronic products that are intended for use by the U.S. Government and whose function or design cannot be divulged by the manufacturer for reasons of national security, as evidenced by government security classification.
(4) Assemblers of diagnostic x-ray equipment subject to the provisions of 1020.30(d) of this chapter, provided the assembler has submitted the report required by 1020.30(d)(1) or (d)(2) of this chapter and retains a copy of such report for a period of 5 years from its date.
Table 1--Record and Reporting Requirements By Product
|Manufacturer||Dealer + Distributor|
|Products||Product reports 1002.10||Supplemental reports 1002.11||Abbreviated reports 1002.12||Annual reports 1002.13||Test records 1002.30(a)
1||Distribution records 1002.30(b)
2||Distribution records 1002.40 and 1002.41|
3 (1020.30, 1020.31, 1020.32, 1020.33)|
|Tube housing assembly||X||X||X||X||X|
|X-ray high voltage generator||X||X||X||X||X||X|
|X-ray table or cradle||X||X||X||X|
|X-ray film changer||X||X||X|
|Vertical cassette holders mounted in a fixed location and cassette holders with front panels||X||X||X||X|
|Spot-film devices and image intensifiers manufactured after April 26, 1977||X||X||X||X||X||X|
|Cephalometric devices manufactured after February 25, 1978||X||X||X|
|Image receptor support devices for mammographic X-ray systems manufactured after September 5, 1978||X||X||X||X|
|CABINET X RAY (1020.40)|
|PRODUCTS INTENDED TO PRODUCE PARTICULATE RADIATION OR X-RAYS OTHER THAN DIAGNOSTIC OR CABINET DIAGNOSTIC X-RAY|
|TELEVISION PRODUCTS (1020.10)|
|lt25 kilovolt (kV) and lt0.1 milliroentgen per hour (mR/hr IRLC
|[gteqt]25kV and lt0.1mR/hr IRLC
|MW ovens (1030.10)||X||X||X||X||X|
|MW heating, drying, security systems||X|
|RF sealers, electromagnetic induction and heating equipment, dielectric heaters (2-500 megahertz)||X|
|Laser products (1040.10, 1040.11)|
|Class I lasers and products containing such lasers
|Class I laser products containing class IIa, II, IIIa, lasers
|Class IIa, II, IIIa lasers and products other than class I products containing such lasers
|Class IIIb and IV lasers and products containing such lasers
|Sunlamp products (1040.20)|
|Mercury vapor lamps (1040.30)|
|Ultrasonic therapy (1050.10)||X||X||X||X||X||X|
|Medical ultrasound other than therapy or diagnostic||X||X|
[60 FR 48382, Sept. 19, 1995; 61 FR 13423, Mar. 27, 1996]