Newsletter - March 31, 2022
US Companies Prefer FDA Approval Over CE Mark for Medical Devices
Recent changes to medical device rules in the EU have made it harder to get CE mark and effectively pushed companies to seek FDA approval prior to the CE mark, found a recent survey of predominantly US-based companies. FDA is perceived to be more responsive and predictable compared to its European counterparts...Read More
You cannot Sue Somebody for Criticizing Your Product, Even if Unfair
A company that manufactures thermometers that predicts fertility status of women sued a vigorous critic of their product for defamation, and the courts dismissed the lawsuit citing protection of the expression of opinion affirming well-established dogma that people can opine freely about a product, negatively...Read More
US Companies Prefer FDA Approval Over CE Mark for Medical Devices
Recent changes to medical device rules in the EU have made it harder to get CE mark and effectively pushed companies to seek FDA approval prior to the CE mark, found a recent survey of predominantly US-based companies. FDA is perceived to be more responsive and predictable compared to its European counterparts...Read More
You cannot Sue Somebody for Criticizing Your Product, Even if Unfair
A company that manufactures thermometers that predicts fertility status of women sued a vigorous critic of their product for defamation, and the courts dismissed the lawsuit citing protection of the expression of opinion affirming well-established dogma that people can opine freely about a product, negatively...Read More
