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Aaron L. Josephson


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Device Modernization Series: FDA’s Changes to the 510(k) Program

USA - February 20 2019 In our “FDA 2018 Year in Review (and a Few Thoughts on 2019)” post and recent webinar, we observed that we may look back at 2018 as the beginning of...

FDA 2018 Year in Review (and a Few Thoughts on 2019)

USA - December 27 2018 As 2019 quickly approaches, we would like to take a few moments to reflect on the past year of Food and Drug Administration activities and certain big...

Joanne Hawana, Benjamin M. Zegarelli, Bethany Hills.

Paradigm Shift: Regulating Software as a Medical Device in the U.S.

USA - December 19 2018 The U.S. Food and Drug Administration (FDA) is exploring the development of a new regulatory approach for software as a medical device (SaMD) that the...

Observations from FDA’s Public Workshop on Medical Device Servicing and Remanufacturing

USA - December 19 2018 On December 10-11, 2018, FDA hosted a public workshop, Medical Device Servicing and Remanufacturing Activities, as part of its effort to develop a...

Benjamin M. Zegarelli.

Medical Products & FDA: What to Watch for in 2019

USA - December 4 2018 Major legislation impacting FDA often accompanies user fee reauthorizations every 5 years. However, Congress has acted to address public health issues...