[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


BILLING CODE 4160-01-C

[[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                                                 
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                              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   
--------------------------------------------------------------------------------------------------------------------------------------------------------
 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