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Media Coverage Articles

Fish’s Keith Barritt Quoted in Bloomberg BNA Medical Devices Law & Industry Report “Device Tax Repeal, FDA’s Actions Affecting Industry Remain Top Issues”

January 26, 2015

Media Coverage Articles

Fish’s Keith Barritt Quoted in Bloomberg BNA Medical Devices Law & Industry Report “Device Tax Repeal, FDA’s Actions Affecting Industry Remain Top Issues”

January 26, 2015

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

‘‘Also of tremendous interest to the Health IT industry,’’ Keith Barritt, of Fish & Richardson in Washington, said, ‘‘the FDA is reportedly working on a draft guidance on the interoperability of medical devices.’’

‘‘This is a critical issue in the interconnected era, especially if a wireless device is part of a larger network.’’ Regarding a potential draft guidance on the dividing line between unregulated general ‘‘health and wellness’’ claims and regulated ‘‘medical device’’ claims, Barritt said, ‘‘This will be of tremendous interest to the growing community of app developers in the broad ‘digital health’ space, and especially for software and mobile medical apps.’’

And according to Barritt, regulation of genetic test kits, especially direct-to-consumer tests, likely will be of continued interest, especially following the FDA’s very public November 2013 warning letter to the company 23andMe. ‘‘In 2014, 23andMe filed a 510(k) application for assessing the risk of only one inherited disorder (Bloom syndrome, associated with short stature and various cancers). As of Jan. 12, there is no indication on the FDA website that marketing authorization had been granted,’’ he said. ‘‘As the technology for and potential use of genetic testing continues to mature, more and more companies will be interested in entering the market.’’

To read the entire article, click here.

Reproduced with permission from Medical Devices Law & Industry Report, 9 MELR 60, 01/21/2015. Copyright 2015 by The Bureau of National Affairs, Inc. (800-372-1033) http://www.bna.com

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