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Breakfast Briefing: How will FDA’s New 2015 Medical Device Guidance Impact You in Digital Health and Software?

K&L Gates
222 Sw Columbia St
Portland, OR 97201, US (map)



The FDA recently posted final guidance documents on medical device data systems and mobile medical applications. The FDA also posted draft guidance on its general wellness policy for low risk devices and medical device accessories. If your company is involved in health data, patient data or fitness these could affect you.

Sifting through these four guidances is challenging, so why not let K&L Gates’ local FDA Attorneys digest the critical information for you? In just 90 minutes, you will learn: How to decipher the FDA’s new approach to regulating - or not regulating - innovative devices such as wearables, mobile apps designed to improve health, and data systems that are empowering physicians to provide improved patient care Which medical devices the FDA deems are of such low risk that it will no longer focus its regulatory oversight on them Which medical devices the FDA will regulate, but under a lower risk classification The grey areas and how to make sure your device remains within its intended classification

Seminar Presenters: Carol. A. Pratt, JD, Ph.D., Partner, K&L Gates LLP Mitchell E. Parrish, JD, RAC, Associate, K&L Gates LLP

Audience: Medical device and health technology professionals Wearables designers and manufacturers Fitness or wellness technology professionals Researchers and physicians *Software programmers and inventors in the healthcare field

Event Details: When: March 6, 2015 Time: 8:30am - 10:00am Where: K&L Gates, LLP, One SW Columbia Street, Suite 1900, Portland, OR 97258