Medical Device Legal News with Sam Bernstein: Episode 11
Over the last few years, the Federal Risk and Authorization Management Program (“FedRAMP”) Program Management Office (“PMO”) has released two draft guidance documents related to defining the applicable boundary for security...more
In 2016, European companies doing business in the US were able to breathe a sigh of relief. The European Commission deemed the Privacy Shield to be an adequate privacy protection. For the next half a decade, this shield, as...more
On 21 June 2017, FDA announced the availability of a new draft guidance titled "Use of Electronic Records and Electronic Signatures in Clinical Investigations Under Part 11 — Questions and Answers." The draft guidance is...more