CFR - Code of Federal Regulations Title 21

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For the most up-to-date version of CFR Title 21, go to the Electronic Code of Federal Regulations (eCFR).

[Code of Federal Regulations]

[Title 21, Volume 8]

[CITE: 21CFR1002.1]

TITLE 21--FOOD AND DRUGS

CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES

SUBCHAPTER J - RADIOLOGICAL HEALTH

PART 1002 -- RECORDS AND REPORTS

Subpart A - General Provisions

Sec. 1002.1 Applicability.

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 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
DIAGNOSTIC X-RAY 3 (1020.30, 1020.31, 1020.32, 1020.33):
Computed tomography					X	X	X
X-ray system 4					X	X	X
Tube housing assembly					X	X
X-ray control					X	X	X
X-ray high voltage generator					X	X	X
X-ray table or cradle					X	X	X
X-ray film changer					X	X
Vertical cassette holders mounted in a fixed location and cassette holders with front panels					X	X	X
Beam-limiting devices					X	X	X
Spot-film devices and image intensifiers manufactured after April 26, 1977					X	X	X
Cephalometric devices manufactured after February 25, 1978					X	X
Image receptor support devices for mammographic X-ray systems manufactured after September 5, 1978					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 X-RAY:
Medical					X	X
Analytical			X	X	X	X
Industrial			X	X	X	X
TELEVISION PRODUCTS (1020.10):
<0.1 milliroentgen per hour (mR/hr) IRLC 5			X 8	X 6
greater than or equal to 0.1mR/hr IRLC 5	X 8			X	X	X
MICROWAVE/RF:
MW ovens (1030.10)	X 8			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:
Laser products (1040.10, 1040.11)
Class I lasers and products containing such lasers 7 9	X 8			X	X
Class I laser products containing class IIa, II, IIIa, lasers 7 9	X			X	X	X
Class IIa, II, IIIa lasers and products other than class I products containing such lasers 7 9	X			X	X	X	X
Class IIIb and IV lasers and products containing such lasers 7	X	X		X	X	X	X
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

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 § 1020.30(d)(1)-(3) of this chapter.

⁴ Systems records and reports are required if a manufacturer exercises the option and certifies the system as permitted in § 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]