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So, ISO 14971:2007 is officially going into a revision as deliberated in the ISO TC 210 Delft meeting today. Now the work begins!!source: https://www.linkedin.com/groups/2070960/2070960-6204883472100651009
During the 10x conference in San Diego last month, we discussed the changes to the EU regulations for CE Marking. If you are interested in downloading the slide decks for free, please visit the following link:http://medicaldeviceacademy.com/10x-2016/...
FDA issued "The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)]" this week. Group member Glenda Guest included the link at http://bit.ly/split-predicate and began a discussion about it. Among the changes are gui...
19 months ago we featured group member Mark DuVal's Citizen Petition and Petition for Stay of Action with the FDA. Read that discussion: http://bit.ly/FDA_petition The petition challenged FDA's practices and interpretations for reviewing 510(k)s and ...
source: https://www.linkedin.com/groups/78665/78665-6146716667671044098
Recently some of my clients received 483 observations for supplier controls and MDR reporting, but one of my clients asked which areas are FDA inspectors emphasizing. I noticed no significant changes, but I thought it was worth revisiting my Pareto A...
Bradley Merrill Thompson, RAC
Medical Device, Digital Health and Combination Product Regulatory Attorney
September 2015
In this paper, I outline in detail the structural biases against anything new in the medical technology realm, including novel software. I wholeheartedly support FDA regulation of risky technology, but the law places disproportionately large regulato...
CDRH published a list of guidance documents it is considering in fiscal year 2017. These include: Final Guidance Topics • Postmarket Management of Cybersecurity in Medical Devices • Medical Device Accessories: Describing Accessories and Classificatio...
The number of medical apps grows by the day, also the capability of such apps continues to improve. With the internet being effectively border-less, is it inevitable, that the regulatory bodies will not be able to control or regulate a significant po...