Update to EU’s Medical Device Clinical Evaluation Guidelines

In June, the European Commission released Revision 4 of MEDDEV 2.7/1 Clinical Evaluation: A Guide for Manufacturers and Notified Bodies, found amidst other guidance documents here. The release constitutes a major re-write of the previously issued guidance (found here), increasing the document from 46 to 65 pages of "how-to" conduct the Clinical Evaluation. Though not legally binding

By | 2017-08-08T21:55:54+00:00 July 6th, 2016|Compliance Updates & Legal Info|

Celebrity Endorsements & the Law

A recent article entitled "Can Plaintiffs Sue a 'Celebrity Spokesperson'?" (see the below link) got me thinking about the interplay between the Federal Trade Commission (FTC) and the Food and Drug Administration (FDA) regarding celebrity endorsements. From the FTC (false and misleading advertising) perspective, a celebrity endorsement generally does not provide a basis for plaintiffs

By | 2017-08-08T21:55:48+00:00 June 28th, 2016|Compliance Updates & Legal Info|