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
After years of requiring most device manufacturers (besides IVD) to spell out the meaning of symbols within their labeling, FDA has issued a final rule that "allows the use of stand-alone symbols in medical devices without adjacent explanatory text". Previously, harmonized symbols recognized globally, such as "2" with a circle around it and slash through it
In Fine Point Consulting's continuing series on Leaders & Influencers, they spoke with Robin Martin, Chief Regulatory Strategist, and Jana Gerken, Chief Legal Strategist, co-founders of the newly formed Kinetic Compliance Solutions, which provides regulatory and legal services to emerging and mature companies specializing in the medical device and life sciences industries. Here is a portion of the
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
The below companies provide services in the medical device, life science and / or biotechnology sectors and are potential resources for our clients.
D1ASP0RA specializes in formation of startups in the biotechnology sector. This includes prototyping the concept, developing a financial model, assessing the market, and preparing the story for investors. Our goal is to democratize the path to new discoveries by providing each new idea an opportunity to reach investors.