[Federal Register Volume 63, Number 163 (Monday, August 24, 1998)]
[Rules and Regulations]
[Page 44998]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-22571]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 892

[Docket No. 96N-0320]


Radiology Devices; Classifications for Five Medical Image 
Management Devices; 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 April 29, 1998 (63 FR 
23385). The document classified, along with other devices, the medical 
image storage device and medical image communications device. These 
devices were classified into Class I and were exempted from the 
requirement of premarket notification when they do not use irreversible 
data compression. The document was published with an incomplete device 
identification and description of the conditions for exemption from 
premarket notification. This document corrects those errors.

EFFECTIVE DATE: August 24, 1998.

FOR FURTHER INFORMATION CONTACT: Loren A. Zaremba, Center for Devices 
and Radiological Health (HFZ-470), Food and Drug Administration, 9200 
Corporate Blvd., Rockville, MD 20850, 301-594-1212.

SUPPLEMENTARY INFORMATION: In the Federal Register of April 29, 1998 
(63 FR 23385), FDA published a final rule classifying certain medical 
image management devices. Under the final rule, the medical image 
storage device and medical image communications device were classified 
into Class I and exempted from the requirement of premarket 
notification when they do not use irreversible data compression. 
Although the preamble of the final rule, as well as the proposal upon 
which the final rule is based, correctly identifies the devices and 
describes the limitation of the exemption from premarket notification, 
an editorial change was mistakenly made in the regulatory language of 
the final rule. As it currently reads, the device identification, not 
the exemption provision, is limited to those devices that do not 
perform irreversible data compression. This has the effect of leaving 
unclassified the medical image storage device and medical image 
communications device that do not perform irreversible data 
compression. This document corrects the error by removing the limiting 
language form the device identification paragraph and reinserting the 
appropriate language in the classification paragraph.
    Furthermore, the agency also notes that in response to the comments 
in the preamble of the April 29, 1998, final rule, the agency 
erroneously stated that ``* * * the class I devices will be exempt from 
the design controls requirement in accordance with Sec. 820.30 (21 CFR 
820.30). FDA believes that design controls are not necessary for class 
I devices in this rule.'' However, under Sec. 820.30(a)(2)(i), devices 
automated with computer software are specifically identified as devices 
which are subject to design controls. Because the medical image storage 
device and medical image communications device described by the 
classification regulation are digital, they are by definition, 
``automated with computer software.'' The agency is therefore 
clarifying that these devices are subject to design controls.
    In FR Doc. 98-11317 appearing on page 23385 in the Federal Register 
of April 29, 1998, the following corrections are made:


Sec. 892.2010   [Corrected]

    1. On page 23387, in the first column, in Sec. 892.2010 Medical 
image storage device, paragraph (a) is corrected by removing the phrase 
``without irreversible data compression'' and paragraph (b) is 
corrected by adding the phrase ``only when the device stores images 
without performing irreversible data compression'' at the end of the 
paragraph.


Sec. 892.2020   [Corrected]

     2. On the same page, in the same column, in Sec. 892.2020 Medical 
image communications device, paragraph (a) is corrected by removing the 
phrase ``without irreversible data compression''
 and paragraph (b) is corrected by adding the phrase ``only when the 
device transfers images without performing irreversible data 
compression'' at the end of the paragraph.

    Dated: August 7, 1998.
D.B. Burlington,
Director, Center for Devices and Radiological Health.
[FR Doc. 98-22571 Filed 8-21-98; 8:45 am]
BILLING CODE 4160-01-F