[Federal Register Volume 61, Number 60 (Wednesday, March 27, 1996)]
[Rules and Regulations]
[Pages 13421-13424]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-7313]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 1000 and 1002
[Docket No. 82N-0273]
RIN 0910-AA15
Records and Reports Regulations for Radiation Emitting Electronic
Products; Correction
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule; correction.
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SUMMARY: The Food and Drug Administration (FDA) is correcting a final
rule that appeared in the Federal Register of September 19, 1995 (60 FR
48374). The document amended FDA regulations regarding the requirements
for recordkeeping and reporting of adverse experiences and other
information relating to radiation emitting electronic products. The
document was published with inadvertent typographical errors. This
document corrects those errors.
EFFECTIVE DATE: October 19, 1995.
FOR FURTHER INFORMATION CONTACT: Joanne Barron, Center for Devices and
Radiological Health (HFZ-300), Food and Drug Administration, 2094
Gaither Rd., Rockville, MD 20850, 301-594-4654.
In FR Doc. 95-23130, appearing on page 48374 in the Federal
Register of Tuesday, September 19, 1995, the following corrections are
made:
1. On page 48381, ``Figure 1'' is republished to correct some
inadvertent errors, as follows:
BILLING CODE 4160-01-F
[[Page 13422]]
[GRAPHIC] [TIFF OMITTED] TR27MR96.001
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[[Page 13423]]
2. Beginning on page 48383, in table 1, is being republished to
correct some inadvertent typographical errors, as follows:
Table 1.--Record and Reporting Requirements By Product
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Manufacturer Dealer &
----------------------------------------------------------------------------------------------------------------------------------------- Distributor
---------------
Product Supplemental Abbreviated Distribution Distribution
Products reports Sec. reports Sec. reports Sec. Annual reports Test records Sec. records Sec. records
1002.10 1002.11 1002.12 Sec. 1002.13 1002.30(a)1 1002.30(b)2 1002.40 and
1002.41
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DIAGNOSTIC X-RAY3 (1020.30, ............... ............... ............... ............... .................. .................. ..............
1020.31, 1020.32, 1020.33)
Computed tomography X X ............... X X X X
X-ray system4 X X ............... X X X X
Tube housing assembly X X ............... X X X ..............
X-ray control X X ............... X X X X
X-ray high voltage generator X X ............... X X X X
X-ray table or cradle ............... ............... X ............... X X X
X-ray film changer ............... ............... X ............... X X ..............
Vertical cassette holders ............... ............... X ............... X X X
mounted in a fixed location
and cassette holders with
front panels
Beam-limiting devices X X ............... X X X X
Spot-film devices and image X X ............... X X X X
intensifiers manufactured
after April 26, 1977
Cephalometric devices ............... ............... X ............... X X ..............
manufactured after February
25, 1978
Image receptor support ............... ............... X ............... X X X
devices for mammographic X-
ray systems manufactured
after September 5, 1978
CABINET X RAY (Sec. ............... ............... ............... ............... .................. .................. ..............
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 DIAGNOSTIC X-RAY
Medical ............... ............... X X X X ..............
Analytical ............... ............... X X X X ..............
Industrial ............... ............... X X X X ..............
TELEVISION PRODUCTS (Sec. ............... ............... ............... ............... .................. .................. ..............
1020.10)
<25 kilovolt (kV) and <0.1 ............... ............... X X6 .................. .................. ..............
milliroentgen per hour (mR/
hr IRLC5,6
25kV and <0.1mR/ X X ............... X .................. .................. ..............
hr IRLC5
0.1mR/hr IRLC5 X X ............... X X X ..............
MICROWAVE/RF ............... ............... ............... ............... .................. .................. ..............
MW ovens (Sec. 1030.10) X X ............... X X X ..............
MW diathermy ............... ............... X ............... .................. .................. ..............
MW heating, drying, security ............... ............... X ............... .................. .................. ..............
systems
RF sealers, electromagnetic ............... ............... X ............... .................. .................. ..............
induction and heating
equipment, dielectric
heaters (2-500 megahertz)
OPTICAL ............... ............... ............... ............... .................. .................. ..............
Phototherapy products X X ............... ............... .................. .................. ..............
Laser products (Secs. ............... ............... ............... ............... .................. .................. ..............
1040.10, 1040.11)
Class I lasers and products X ............... ............... X X .................. ..............
containing such lasers7
Class I laser products X ............... ............... X X X ..............
containing class IIa, II,
IIIa, lasers7
Class IIa, II, IIIa lasers X X ............... X X X X
and products other than
class I products containing
such lasers7
Class IIIb and IV lasers and X X ............... X X X X
products containing such
lasers7
Sunlamp products (Sec. ............... ............... ............... ............... .................. .................. ..............
1040.20)
Lamps only X ............... ............... ............... .................. .................. ..............
Sunlamp products X X ............... X X X X
Mercury vapor lamps (Sec. ............... ............... ............... ............... .................. .................. ..............
1040.30)
T lamps X X ............... X .................. .................. ..............
R lamps ............... ............... X ............... .................. .................. ..............
ACOUSTIC ............... ............... ............... ............... .................. .................. ..............
Ultrasonic therapy (1050.10) X X ............... X X X X
[[Page 13424]]
Diagnostic ultrasound ............... ............... X ............... .................. .................. ..............
Medical ultrasound other X X ............... ............... .................. .................. ..............
than therapy or diagnostic
Nonmedical ultrasound ............... ............... X ............... .................. .................. ..............
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\1\However, authority to inspect all appropriate documents supporting the adequacy of a manufacturer's compliance testing program is retained.
\2\The requirement includes Secs. 1002.31 and 1002.42, if applicable.
\3\Report of Assembly (Form FDA 2579) is required for diagnostic x-ray components; see 21 CFR 1020.30(d)(1) through (d)(3).
\4\Systems records and reports are required if a manufacturer exercises the option and certifies the system as permitted in 21 CFR 1020.30(c).
\5\Determined using the isoexposure rate limit curve (IRLC) under phase III test conditions (1020.10(c)(3)(iii)).
\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.
Sec. 1002.3 [Corrected]
3. On page 48385, in the first column, in Sec. 1002.3, in line 6,
the comma is removed after the word ``product'' and in line 7, a comma
is added after the word ``purchaser''.
Dated: March 19, 1996.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 96-7313 Filed 3-26-96; 8:45 am]
BILLING CODE 4160-01-F