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The U.S., Canada, Australia and Brazil were supposed to begin shared audits this month under the International Medical Device Regulators Forum’s medical device single audit program. Read More
Coronary devicemaker HeartWare International has received an FDA warning letter related to the company’s Miami Lakes, Fla., manufacturing facility. Read More
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