The provisions of this part are applicable as follows:
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-RAY3 (1020.30, 1020.31, 1020.32, 1020.33): | |||||||
Computed tomography | X | X | X | ||||
X-ray system4 | 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): | |||||||
[LESS THAN]0.1 milliroentgen per hour (mR/hr) IRLC5 | X8 | X6 | |||||
[GREATER THAN EQUAL TO]0.1mR/hr IRLC5 | X8 | X | X | X | |||
MICROWAVE/RF: | |||||||
MW ovens (1030.10) | X8 | 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 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 | ||
Class IIIb and IV lasers and products containing such lasers7 | 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.
21 C.F.R. §1002.1