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MedDeviceSupplyChain.com is the premier source for information and practical advice about supply chain quality issues for medical device manufacturers. We provide the latest news and guidance for building and maintaining a supplier quality management program that satisfies the latest global regulatory quality requirements.


FEATURED ARTICLES
CDRH: Email Recall Notices Could Pose HIPAA Risks
CDRH: Email Recall Notices Could Pose HIPAA Risks Emailing recall notices to clients may seem efficient, but it could cause a host of concerns around confidentiality and effectiveness, a CDRH official warns. Ronny Brown, chief of the CDRH recall branch, told attendees at FDAnews' 11th Annual Medical Device Quality Congress that while the FDA has been looking at ways to incorporate newer technologies into recall announcements, questions about due diligence remain. . . . more
Commerce Dept. to Provide Key Conflict Mineral Data in September
Commerce Dept. to Provide Key Conflict Mineral Data in September The Department of Commerce plans to submit a list of all known conflict mineral processing facilities to Congress by Sept. 1, according to a new report from the Government Accountability Office. GAO recommends that DOC give Congress a plan, including timeframes, for compiling and reporting the information, which was supposed to be completed by January 2013. . . . more
Smith & Nephew Warned on Recall Notification, GMP Deficiencies
Smith & Nephew Warned on Recall Notification, GMP Deficiencies The FDA has warned Smith & Nephew for failing to report a recall of the Renasys soft port dressing, used with its Renasys line of negative pressure wound treatment devices. In March 2013, the company distributed a bulletin to users notifying them of changes to the dressing design. The modifications were made after Smith & Nephew found that improper installation of the filter could result in failure to activate the full/blockage alarm, according to the June 11 warning letter published online July 8. The company neither notified the FDA nor provided written justification for not doing so, the letter says. . . . more
Devicemakers Should Focus on Resolution, Not Number, of CAPA Files: CDRH Official
Devicemakers Should Focus on Resolution, Not Number, of CAPA Files: CDRH Official Devicemakers should never be concerned that an FDA inspector will cite them for opening "too many" corrective and preventative actions, a CDRH official says. Jay Jariwala, a quality systems specialist in CDRH's Office of Compliance, said "the number of CAPAs is the least of [his] worries" during a site inspection. Instead, he's looking for evidence of how a facility uses its CAPA system, Jariwala said. . . . more
IMDRF Single Audit Pilot Delayed for a Few Weeks
IMDRF Single Audit Pilot Delayed for a Few Weeks 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. However, the first third-party auditing organizations are not yet accredited, Gert Bos, head of regulatory and clinical affairs at BSI says. . . . more
Enhancement Medical Warned Over Audits, Supplier Evaluations
Enhancement Medical Warned Over Audits, Supplier Evaluations Enhancement Medical received a warning letter for failing to document supplier evaluations related to production of the Expression intranasal splint. The Wauwatosa, Wisc., company's procedures require a new vendor qualification form for potential suppliers, contractors and consultants. However, such a form did not exist for a contract manufacturer, contract testing facility, stem sterilizer or raw material supplier for hyaluronic acid, according to the June 4 warning letter posted online June 17. . . . more
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