§ 1002.1 - Applicability.

§ 1002.1 Applicability.

Cross Reference

Link to an amendment published at 88 FR 3652, Jan. 20, 2023.

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 to § 1002.1 - Record and Reporting Requirements By by Product

XXXXX 6§ §§ §

Manufacturer							Dealer & Distributor 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
DIAGNOSTIC X-RAY3 (1020.30, 1020.31, 1020.32, 1020.33):
Computed tomography					X	X	X
X	X	X	-ray system4					X	X	X	X	X	X
Tube housing assembly					X	X
X	X	X	-ray control					X	X	X
X	X	X	-ray high voltage generator					X	X	X
X	X	X	-ray table or cradle					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
Beam-limiting devices					X	X	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):
Baggage inspection	X	X		X	X	X	X
Other	X	X		X	X	X
PRODUCTS INTENDED TO PRODUCE PARTICULATE RADIATION OR X-RAYS OTHER THAN DIAGNOSTIC OR CABINET DIAGNOSTIC X-RAY:
Medical					X	X	X	X
Analytical			X	X	X	X
Industrial			X	X	X	X
TELEVISION PRODUCTS (§ 1020.10)<25 kilovolt (kV) and :
<0.1 milliroentgen per hour (mR/hr) IRLC5			X8	X6
≥25kV and <0.1mR/hr IRLC5	X	X	X	≥0.1mR/hr IRLC5	X8			X	X	X	X
MICROWAVE/RF:
MW ovens (	1030.10)	X8			X	X	X	X
MW diathermy			X
MW heating, drying, security systems			X
RF sealers, electromagnetic induction and heating equipment, dielectric heaters (2-500 megahertz)			X
OPTICAL	Phototherapy products	X	X	:
Laser products (	1040.10, 1040.11)
Class I lasers and products containing such lasers7 9	X8			X	X
Class I laser products containing class IIa, II, IIIa, lasers7 9	X			X	X	X
Class IIa, II, IIIa lasers and products other than class I products containing such lasers7 9	X			X	X	X	X	X
Class IIIb and IV lasers and products containing such lasers7	X	X		X	X	X	X
Sunlamp products SUNLAMP PRODUCTS (§ 1040.20):
Lamps only	X
Sunlamp products	X	X		X	X	X	X
Mercury vapor lamps (	1040.30)
R lamps and T lamps			X	X	X	R lamps	X	ACOUSTIC	Ultrasonic therapy (1050.10)	X	X	X	X	X	X	Diagnostic ultrasound	X	Medical ultrasound other than therapy or diagnostic	X	X	Nonmedical ultrasound	X

¹ However, authority to inspect all appropriate documents supporting the adequacy of a manufacturer's compliance testing program is retained.

² The requirement includes §§ 1002.31 and 1002.42, if applicable.

³ Report of Assembly (Form FDA 2579) is required for diagnostic x-ray components; see 21 CFR § 1020.30(d)(1) through -(d)(3) of this chapter.

⁴ Systems records and reports are required if a manufacturer exercises the option and certifies the system as permitted in 21 CFR § 1020.30(c) of this chapter.

⁵ Determined using the isoexposure rate limit curve (IRLC) under phase III test conditions (§ 1020.10(c)(3)(iii)) of this chapter.

⁶ Annual report is for production status information only.

⁷ Determination of the applicable reporting category for a laser product shall be based on the worst-case hazard present within the laser product.

⁸ Manufacturers are exempt from product reports (§ 1002.10) and abbreviated reports (§ 1002.12), except the first product or abbreviated report for each category of: television products; microwave ovens; and products that are Class I laser under any condition of operation, maintenance, service, or failure (e.g., Class I optical disc products, laser printers).

⁹ Manufacturers that incorporate a certified laser system meeting the conditions of 21 CFR 1010.2(e) are considered distributors of the certified laser and only subject to the applicable distribution recordkeeping requirements under §§ 1002.40 and 1002.41 for the certified products.

[60 FR 48382, Sept. 19, 1995; 61 FR 13423, Mar. 27, 1996, as amended at 88 FR 3652, Jan. 20, 2023]