FDA Modifies Medical Device Labeling Requirements

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

By |2017-08-08T21:57:16+00:00June 30th, 2016|Medical Device Information|

Leaders & Influencers: Robin Martin & Jana Gerken

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

By |2023-12-13T13:44:19+00:00June 30th, 2016|Kinetic Compliance News|
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