[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]


-----------------------------------------------------------------------

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Imaging Systems; Draft Guidance; Availability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.

-----------------------------------------------------------------------

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availability of a draft guidance document entitled ``A Primer on 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DATES: Submit written comments on the draft guidance document by August 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ADDRESSES: Requests for single copies of the draft guidance document 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 This draft guidance 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]
BILLING CODE 4160-01-F