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Emailing recall notices to clients may seem efficient, but it could cause a host of concerns around confidentiality and effectiveness, a CDRH official warns. Read More
Enhancement Medical received a warning letter for failing to document supplier evaluations related to production of the Expression intranasal splint. Read More
South Africa is taking another stab at regulating medical devices and in vitro diagnostic products, this time via a regulation that would bring them under the purview of the Medicines Control Council. Read More
Medtech companies are under no obligation to correct misleading third-party statements or claims about their products made on social media, websites and online forums — even if the website is owned by the manufacturer. Read More
Over the next five years the FDA plans to increasingly coordinate its inspections and enforcement activities with its international counterparts. Read More