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    Joe Hage
    🔥 Find me at MedicalDevicesGroup.net 🔥
    August 2015
    Substantial Equivalence: FDA, CMS, and Patents
    This is one of my better posts. You'll want to bookmark and share it. And you'll want to watch http://medgroup.biz/substantial, a 19-minute compilation from 2014's 10x Medical Device Conference. It features Ed Black, Tom KraMer, Pat Kullmann, Doug Li...
    Joe Hage
    🔥 Find me at MedicalDevicesGroup.net 🔥
    June 2017
    FDA Commissioner lays groundwork for digital health innovation plan including certification program
    As originally shared by Julie Omohundro Principal Consultant at Class Three, LLC Thanks, Ginger. I've been thinking that if these devices pose low enough risk to support market entry based on certification alone, they pose low enough risk that they w...
    Joe Hage
    🔥 Find me at MedicalDevicesGroup.net 🔥
    September 2017
    FDA’s Guidance on Real-World Evidence
    Group member Roger Cepeda wrote an informative (and cleverly worded) piece at https://medgroup.biz/RWE called "FDA’s Guidance on Real-World Evidence for Medical Devices: Great for Class III Registry Participants, But What About the Rest of MedTech?" ...
    Joe Hage
    🔥 Find me at MedicalDevicesGroup.net 🔥
    January 2013
    When the FDA medical device approval process goes wrong
    Surgeon's Criticism of FDA Echoed in Senator's Book It's the situation we all dread: A device with an obvious market and strong evidence of effectiveness bogs down in a seemingly endless FDA approval process. According to Colorado surgeon Dr. Robert ...
    D. Michelle Williams
    VP - Operations at Action Products, Inc.
    November 2016
    How do you address requests from customers for GMDN codes and FDA Listing numbers?
    source: https://www.linkedin.com/groups/2070960/2070960-6200379152344846338
    Joe Hage
    🔥 Find me at MedicalDevicesGroup.net 🔥
    June 2015
    FDA answers cybersecurity questions
    "Cybersecurity isn’t just a design issue. It’s not just at product launch. It’s a life cycle issue. It requires a change in mindset." So said FDA’s Suzanne Schwartz, MD, MBA, the Director of Emergency Preparedness/Operations and Medical Countermeasur...
    Mark King
    Writer at iBASEt
    November 2015
    FDA Software Validations
    FDA Software Validations Are Tied to Manufacturer’s Implementation | iBASEtA very common misunderstanding of this validation requirement is that FDA compliance can be met by having their software vendors “validate” the software they are selling.sourc...
    Joe Hage
    🔥 Find me at MedicalDevicesGroup.net 🔥
    August 2014
    FDA Said No
    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 ...
    Rob Packard
    Ship & Print Your FDA eCopy
    May 2016
    Which areas are FDA inspectors emphasizing?
    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
    We cannot afford an FDA regulatory system that discourages new, low risk medical technology
    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...
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