10804. APPLICABILITY

10804 APPLICABILITY 10804.1 The provisions of this chapter are applicable as follows: All manufacturers of electronic products are subject to § 10815; Manufacturers, dealers, and distributors of electronic products are subject to the provisions set forth in table 1 of this section, unless excluded by Paragraph (c) or an exemption has been granted under § 10818 or 10819; and (c) The requirements 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 1of 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 § 10853.5 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; or (4) Assemblers of diagnostic x-ray equipment subject to the provisions of § 10853.6 of this chapter, provided the assembler has submitted the report required by § 10853.7 or 10853.8 of this chapter and retains a copy of such report for a period of five (5) years from its date. Table 1. -- Record and Reporting Requirements By Product Manufacturer Products Product reports § 10808 Supplemental reports § 10809 Abbreviated reports § 10810 Annual reports § 10811 DIAGNOSTIC X-RAY (10853, 10854, 10855) Computed tomography X X X X-ray system X X X Tube housing assembly X X X X-ray control X X X X-ray high voltage generator X X X X-ray table or cradle X X-ray film changer X Vertical cassette holders mounted in a fixed location and cassette holders with front panels 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 Image receptor support devices for mammographic X-ray systems manufactured after September 5, 1978 X CABINET X RAY Baggage inspection X X X Other X X X Products intended to produce particulate radiation or x-rays other than diagnostic or cabinet diagnostic x-ray Medical X X Analytical X X Industrial X X TELEVISION PRODUCTS <25 kilovolt (kV) and <0.1 X X fn6 milliroentgen per hour (mR/hr.) IRLC, (gteqt) 25kV and <0.1mR/hr IRLC X X X (gteqt) 0.1mR/hr IRLC X X X MICROWAVE/RF MW ovens 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 Class I lasers and products containing such lasers X X Class I laser products containing class IIa, II, IIIa, lasers X X Class IIa, II, IIIa lasers and products other than class I products containing such lasers X X X Class IIIb and IV lasers and products containing such lasers X X X Sunlamp products Lamps only X Sunlamp products X X X Mercury vapor lamps T lamps X X X R lamps X ACOUSTIC Ultrasonic therapy X X X Diagnostic ultrasound X Medical ultrasound other than therapy or diagnostic X X Nonmedical ultrasound X Table 1. -- Record and Reporting Requirements By Product Manufacturer Dealer & Distributor Products Test records Distribution Distribution § 10816.1(a) records records § 10816.1(b) §§ 10812 and 10813 DIAGNOSTIC X-RAY (10853, 10854, 10855) Computed tomography X X X X-ray system 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 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 Baggage inspection X X X Other X X PRODUCTS INTENDED TO PRODUCE PARTICULATE RADIATION OR X-RAYS OTHER THAN DIAGNOSTIC OR CABINET DIAGNOSTIC X-RAY Medical X X Analytical X X Industrial X X TELEVISION PRODUCTS (§ 10851) 1t25 kilovolt (kV) and 1t0.1 milliroentgen per hour (mR/hr.) IRLC, 1t25 kV and 1t0.1 mR/hr. IRLC t]25kV and 1t0. X X MICROWAVE/RF MW ovens X X MW diathermy MW heating, drying, security systems RF sealers, electromagnetic induction and heating equipment, dielectric heaters (2-500 megahertz) OPTICAL Phototherapy products Laser products Class I lasers and products containing such lasers X Class I laser products containing class IIa, II, IIIa, lasers X X Class IIa, II, IIIa lasers and products other than class I products containing such lasers X X X Class IIIb and IV lasers and products containing such lasers X X X Sunlamp products Lamps only Sunlamp products X X X Mercury vapor lamps T lamps R lamps ACOUSTIC Ultrasonic therapy X X X Diagnostic ultrasound Medical ultrasound other than therapy or diagnostic Nonmedical ultrasound SOURCE: Final Rulemaking published at 60 DCR 10252 (July 12, 2013). Report of Assembly (Form FDA 2579) is required for diagnostic x-ray components; see 21 C.F.R. § 1020.30(d)(1) through (d)(3). Systems records and reports are required if a manufacturer exercises the option and certifies the system as permitted in 21 C.F.R. § 1020.30(c). Determined using the isoexposure rate limit curve (IRLC) under phase III test conditions (21 C.F.R. § 1020.10(c)(3)(iii)). Annual report is for production status information only. Determination of the applicable reporting category for a laser product shall be based on the worst-case hazard present within the laser product. Id. Id. Id. However, authority to inspect all appropriate documents supporting the adequacy of a manufacturer’s compliance testing program is retained. The requirement includes §§ 10817 and 10814, if applicable. Report of Assembly is required for diagnostic x-ray components; see § 10853.7 through 10853.9. Systems records and reports are required if a manufacturer exercises the option and certifies the system as permitted in § 10853.6. Determined using the isexposure rate limit curve (IRLC) under phase III test conditions (§ 10851.4(c)). Annual report is for production status information only. Determination of the applicable reporting category for a laser product shall be based on the worst-case hazard present within the laser product. Id. Id. Id. District of Columbia Municipal Regulations Public Health and Medicine 22-B DCMR § 10804