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Articles

Fish’s Keith Barritt Quoted in BNA's Medical Devices Law & Industry Report “FCC Approval of Software for Transmitter Testing Should Speed Development, Cut Costs”

March 23, 2011

Articles

Fish’s Keith Barritt Quoted in BNA's Medical Devices Law & Industry Report “FCC Approval of Software for Transmitter Testing Should Speed Development, Cut Costs”

March 23, 2011

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Keith Barritt (DC) was quoted in BNA’s Medical Devices Law & Industry Report.

Attorney Keith Barritt, with Fish & Richardson PC in Washington, told BNA March 14 that the FCC ruling would be helpful to medical device manufacturers, but cautioned that it was not certain whether the Food and Drug Administration would accept FEM technique.

 

‘‘It is always good for industry to have options when demonstrating compliance with FCC rules, and for some manufacturers the waiver may present a significant improvement over alternative evaluation techniques,’’ Barritt said.

 

‘‘Of course, for medical device manufacturers, meeting FCC requirements is only half the battle. Considering the new cooperative agreement between FCC and FDA announced last summer, hopefully the FDA will not question use of this new measurement technique to meet its relevant requirements for marketing authorization.’’

Reproduced with permission from Medical Devices Law & Industry Report, 5 MELR 182 (Mar. 23, 2011).  Copyright 2011 by The Bureau of National Affairs, Inc. (800-372-1033) http://www.bna.com/

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