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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
CoHiTech, a Barcelona, Spain, manufacturer of tampons and menstrual pads received an FDA warning letter for in-process testing procedures and other quality issues. Read More
CINCINNATI — With September’s deadline for displaying unique device identifiers on high-risk devices just around the corner, rollout for many manufacturers is well underway. Read More
Natus Manufacturing Limited, an Irish devicemaker, received an FDA Form 483 for slips related to acceptance activities and contamination-prevention procedures. Read More