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FDA draft guidance on medical device data systems, issued last week, “significantly reduces the regulatory status of MDDS — in essence eliminating all regulatory requirements for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
Lack of FDA clarity on when 510(k)s need to be filed for modified devices led Smith & Nephew to temporarily pull a wound care product from the market. Read More
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
Failure to include women in device trials may be blocking important discoveries in new treatment modalities, CDRH says in commentary on a study published in JAMA: Internal Medicine. Read More
Devicemakers should never be concerned that an FDA inspector will cite them for opening “too many” corrective and preventative actions, a CDRH official 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
Lawyers are advising devicemakers preparing conflict mineral reports due to the Securities and Exchange Commission this month to put more effort into describing their compliance with the Organisation for Economic Co-operation and Development’s due diligence guidelines. Read More