[Federal Register Volume 62, Number 99 (Thursday, May 22, 1997)]
[Notices]
[Page 28056]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-13377]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 97D-0146]
A Primer on Medical Device Interactions With Magnetic Resonance
Imaging Systems; Draft Guidance; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a draft guidance document entitled ``A Primer on
Medical Device Interactions with Magnetic Resonance Imaging Systems.''
The purpose of this document is twofold. It should serve to sensitize
medical device reviewers to the meaning and ramifications of magnetic
resonance (MR) safety or MR compatibility claims. It will also provide
for FDA reviewers a background of MR theory and the effect the MR
environment may have on medical devices.
DATES: Submit written comments on the draft guidance document by August
20, 1997.
ADDRESSES: Requests for single copies of the draft guidance document
and any written comments to the Dockets Management Branch (HFA-305),
Food and Drug Administration, 12420 Parklawn Dr., rm. 1-23, Rockville,
MD 20857.
FOR FURTHER INFORMATION CONTACT: Marlene Skopec, Center for Devices and
Radiological Health (HFZ-133), Food and Drug Administration, 12721
Twinbrook Pkwy., Rockville, MD 20852, 301-443-3840.
SUPPLEMENTARY INFORMATION: FDA recognizes that there is an increasing
number of medical device manufacturers seeking to make MR safe or MR
compatibility claims for their devices. It is important that medical
device reviewers are aware of the potential implications of these
claims. With the advent of open magnetic resonance imaging (MRI)
systems and interventional MR, the trend of making MR claims for
medical devices will continue and accelerate. This draft guidance
document is intended to serve as a general background document on
medical device interactions in MRI systems. It is not intended to
replace documents created that address specific devices or device
areas.
A guidance document does not bind FDA or the public, and does not
create or confer any rights, privileges, or benefits for or on any
person; however, it does represent the agency's current thinking on the
subjects discussed therein. The draft guidance document announced in
this notice represents the agency's tentative thinking of the subjects
discussed therein.
Interested persons may, on or before August 20, 1997, submit to the
Dockets Management Branch (address above) written comments on ``A
Primer on Medical Device Interactions with Magnetic Resonance Imaging
Systems.'' Two copies of any comments are to be submitted, except that
individuals may submit one copy. Comments are to be identified with the
docket number found in brackets in the heading of this document. ``A
Primer on Medical Device Interactions with Magnetic Resonance Imaging
Systems'' and received comments may be seen in the office above between
9 a.m. and 4 p.m., Monday through Friday.
Dated: April 21, 1997.
Joseph A. Levitt,
Deputy Director for Regulations Policy, Center for Devices and
Radiological Health.
[FR Doc. 97-13377 Filed 5-21-97; 8:45 am]
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