D.C. Mun. Regs. tit. 22, r. 22-B10804

Current through Register Vol. 71, No. 49, December 6, 2024

Rule 22-B10804 - APPLICABILITY

10804.1

The provisions of this chapter are applicable as follows:

(a) All manufacturers of electronic products are subject to § 10815;

(b) 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-RAY¹
(10853, 10854, 10855)
Computed tomography	X	X	X
X-ray system²	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.)
IRLC³^,4
(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 lasers⁵	X	X
Class I laser products containing class IIa, II, IIIa, lasers⁶	X	X
Class IIa, II, IIIa lasers and products other than class I products containing such lasers⁷	X	X	X
Class IIIb and IV lasers and products containing such lasers⁸	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)⁹	records	records
§ 10816.1(b)¹⁰	§§ 10812
and 10813
DIAGNOSTIC X-RAY¹¹ (10853, 10854, 10855)
Computed tomography	X	X	X
X-ray system¹²	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.) IRLC¹³^,14
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 lasers¹⁵	X
Class I laser products containing class IIa, II, IIIa, lasers¹⁶	X	X
Class IIa, II, IIIa lasers and products other than class I products containing such lasers¹⁷	X	X	X
Class IIIb and IV lasers and products containing such lasers¹⁸	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

¹Report of Assembly (Form FDA 2579) is required for diagnostic x ray components; see 21 C.F.R. § 1020.30(d)(1) through (d)(3).

²Systems 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).

³Determined using the isoexposure rate limit curve (IRLC) under phase III test conditions ( 21 C.F.R. § 1020.10(c)(3)(iii)) .

⁴Annual report is for production status information only.

⁵Determination of the applicable reporting category for a laser product shall be based on the worst-case hazard present within the laser product.

⁶Id.

⁷Id.

⁸Id.

⁹However, authority to inspect all appropriate documents supporting the adequacy of a manufacturer's compliance testing program is retained.

10The requirement includes §§ 10817 and 10814, if applicable.

11Report of Assembly is required for diagnostic x ray components; see § 10853.7 through 10853.9.

12Systems records and reports are required if a manufacturer exercises the option and certifies the system as permitted in § 10853.6.

13Determined using the isexposure rate limit curve (IRLC) under phase III test conditions (§ 10851.4(c)).

14Annual report is for production status information only.

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

16Id.

17Id.

18Id.

D.C. Mun. Regs. tit. 22, r. 22-B10804

Final Rulemaking published at 60 DCR 10252 (July 12, 2013)

Authority: Section 19(a)(3) of the District of Columbia Pharmacist and Pharmacy Regulation Act of 1980, effective September 16, 1980 (D.C. Law 3-98; D.C. Official Code § 47-2885.18(a)(3) (2005 Repl.)); Mayor's Order 98-48, dated April 15, 1998; Section 4902 of the Fiscal Year 2002 Budget Support Act of 2001, effective October 3, 2001 (D.C. Law 14-28; D.C. Official Code § 7-731 (2008 Repl.)); Section 15 of the District of Columbia Medical Device Manufacture and Distribution Licensure Act of 1990, effective June 13, 1990 (D.C. Law 8-137; D.C. Official Code § 48-714(a) (2005 Repl.)); and Mayor's Order 98-88, dated May 29, 1998.