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A series of joint assessments of EU device notified bodies found a “generally satisfactory” level of compliance with legal requirements and best practices, but revealed multiple issues with organizational requirements and quality management systems, according to an interim report by the Notified Bodies of Government. Read More
An interim report on the joint assessments of EU device notified bodies (NBs) shows there is room for improvement in the planning, scope and depth of surveillance activities. Read More
Avacen, maker of The Avacen Thermal Exchange System (TATES), was hit with a nine-citation FDA warning letter for failing to establish a host of essential GMP procedures. Read More
FDA investigators increasingly are shifting from “top down” inspections focused on policies to “bottom up” inspections that focus on raw data, an industry insider says. Read More
Manufacturers should use a two-step approach to grade nonconforming products — a matrix for determining the initial number, followed by escalations to set a final grade, according to a proposed guidance released last week by the Asian Harmonization Working Party. Read More
Medical devicemakers should be aware that they have become “lower-hanging fruit” for FDA enforcement of off-label promotion rules, and so have online product communications, two experts say. Read More
Aptalis, a specification developer for the Flutter mucus clearance device, failed to report a contract manufacturer’s rework of devices to correct issues both this year and in 2012, a recent FDA warning letter says. Read More
The FDA has released a previously announced warning letter to spine implant maker Globus Medical, citing the company for releasing five lots of MicroFuse putty that did not meet its own specification for mechanical testing. Read More
St. Petersburg, Fla.-based Lenstec fielded an FDA Form 483 after “canceling” 15 complaints attributed to user error, rather than closing them. Read More
Retractable Technologies’ device history records do not include a cycle chart for part of the sterilization cycle used by one of the company’s contract sterilizers for 1cc and 3cc VanishPoint syringe product lines, according to a recent Form 483. Read More
The International Medical Device Regulators Forum will launch its medical device single audit program (MDSAP) pilot in January in the U.S., Canada, Australia and Brazil. Read More
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