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U.S. Department of Health and Human Services

CFR - Code of Federal Regulations Title 21

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The information on this page is current as of Mar 22, 2024.

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

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Help | More About 21CFR
[Code of Federal Regulations]
[Title 21, Volume 8]
[CITE: 21CFR1002.1]
See Related Information on Applicability. in CDRH databases



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 tomographyXXX
X-ray system 4XXX
Tube housing assemblyXX
X-ray controlXXX
X-ray high voltage generatorXXX
X-ray table or cradleXXX
X-ray film changerXX
Vertical cassette holders mounted in a fixed location and cassette holders with front panelsXXX
Beam-limiting devicesXXX
Spot-film devices and image intensifiers manufactured after April 26, 1977XXX
Cephalometric devices manufactured after February 25, 1978XX
Image receptor support devices for mammographic X-ray systems manufactured after September 5, 1978XXX
CABINET X RAY (1020.40):
Baggage inspectionXXXXXX
OtherXXXXX
PRODUCTS INTENDED TO PRODUCE PARTICULATE RADIATION OR X-RAYS OTHER THAN DIAGNOSTIC OR CABINET X-RAY:
MedicalXX
AnalyticalXXXX
IndustrialXXXX
TELEVISION PRODUCTS (1020.10):
<0.1 milliroentgen per hour (mR/hr) IRLC 5X 8X 6
greater than or equal to 0.1mR/hr IRLC 5X 8XXX
MICROWAVE/RF:
MW ovens (1030.10)X 8XXX
MW diathermyX
MW heating, drying, security systemsX
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 9X 8XX
Class I laser products containing class IIa, II, IIIa, lasers 7 9XXXX
Class IIa, II, IIIa lasers and products other than class I products containing such lasers 7 9XXXXX
Class IIIb and IV lasers and products containing such lasers 7XXXXXX
SUNLAMP PRODUCTS (1040.20):
Lamps onlyX
Sunlamp productsXXXXXX
Mercury vapor lamps (1040.30)
R lamps and T lampsX

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]

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