April 7, 2016
Fish's Keith Barritt quoted in BNA's Medical Devices Law & Industry Report on 510 (k) Clearances
Keith Barritt (DC) was quoted in BNA’s Medical Devices Law & Industry Report.
Keith Barritt, an attorney with Fish & Richardson in Washington, told BNA that anything FDA can do to help educate the devices industry on the scope of information the agency believes is necessary to meet the “substantial equivalence” standard of the 510(k) program is welcome.
However, Barritt noted that under the substantial equivalence standard, devices cleared under the 510(k) program do not necessarily need to be safe and effective.
“As long as the FDA is stuck with the ‘substantial equivalence’ standard, for better or worse, there will always be debate and controversy over how much information the FDA can demand from a manufacturer who under the statute only needs to show substantial equivalence, which does not necessarily equate to a showing of safety and effectiveness,” Barritt said.
Reproduced with permission from Medical Devices Law & Industry Report, 4 MELR 557 (Aug. 11, 2010). Copyright 2010 by The Bureau of National Affairs, Inc. (800-372-1033) http://www.bna.com
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