[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
