'Substantially equivalent' presentation slideshows

Pamela Furman Forrest, Esq. Partner, King & Spalding LLP pforrest@kslaw 202.661.7888

Basic Principles of FDA Medical Device Regulation and How FDA Might Have Handled the Recent PIP Crisis British Institute of International and Comparative Law June 10, 2013. Pamela Furman Forrest, Esq. Partner, King & Spalding LLP pforrest@kslaw.com 202.661.7888. Agenda.

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Premarket Notification 510(k) process

Premarket Notification 510(k) process. medical device classification. Regulatory classes were established in 1976 thanks to the Medical Device Amendment. It defined the degree of control necessary to ensure that the devices are safe and effective. Classification :

187 views • 13 slides

Economic Strike

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RAC Practice Exam

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