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Health Line International, a Chinese devicemaker, received an FDA Form 483 for delaying effectiveness checks on CAPAs and other quality issues. Read More
Stryker will use ongoing inquiries to continually assess its supplies for conflict minerals, according to a new supply chain policy outlined in the company’s first conflict minerals disclosure report to the SEC. Read More
The FDA’s draft guidance on distinguishing recalls from product enhancements contradicts current regulations, creating “a new sort of burden for industry,” an attorney says. Read More
The FDA’s new changes to data elements within its Global Unique Device Identification Database have dealt a setback to manufacturers who were well into the process of assigning UDIs to their products. Read More
FDA draft guidance on medical device data systems, issued last week, “significantly reduces the regulatory status of MDDS — in essence eliminating all regulatory requirements for these medical devices,” an expert says. Read More
Labs that pay physicians for handling blood samples or providing registry data could face kickback sanctions, according to a recent fraud alert from HHS’ Office of the Inspector General. 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
A pair of resolutions proposed by Anvisa would give manufacturers of in vitro diagnostics and low-risk medical devices an easier time registering their products in Brazil. Read More