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Devicemakers saw an increase in 2013 in the number of FDA 483s that cite inadequate supplier controls; the finding is now one of the top five most common 483 findings for devicemakers. Read More
The U.S. Food and Drug Administration does not mandate the use of specific international standards, allowing manufacturers to explore science-based alternatives. Read More
The U.S. Food and Drug Administration may withdraw a humanitarian device exemption if it subsequently approves a premarket approval application or clears a 510(k) for a humanitarian-use device or a comparable device with the same indication, draft Q&A guidance explains. Read More
The European Parliament advanced major data privacy legislation in March, but not before amending two provisions that industry had said would cripple clinical research. Read More
The UK’s Medicines and Healthcare products Regulatory Agency issued guidance late last month clarifying when standalone software qualifies as a medical device from a regulatory standpoint. Read More
The National Institute for Health and Care Excellence would consider “burden of illness” as a measurable component when assessing new medical devices for reimbursement, under a plan for value-based assessment of health technologies. Read More
Manufacturers of a wide range of medical devices would be barred from bidding on Russian state procurement contracts if their products are not locally made, under a policy proposed by the Ministry of Industry and Trade. Read More
The International Medical Device Regulators forum will immediately suspend auditing organizations from the Medical Device Single Audit Program if there is evidence of any wrongdoing during a facility audit. Read More
The European Commission’s Scientific Committee on Emerging Newly Identified Health Risks is recommending a step-by-step approach to the introduction of new or technically modified metal-on-metal joint implants, citing continued concerns about the higher risks and poorer durability vis-à-vis alternative materials such as polyethylene. Read More