FDA Submission for Combination Products How do you determine the correct FDA submission for combination products? What IS a combination product? A In category: FDA Approval LinkedIn Regulatory Quality
FDA Submission Types, Costs and Timeframes – Which is Right for You? Very few days go by without someone asking me to explain the differences between FDA submission types. This most In category: FDA Approval LinkedIn Regulatory Quality
Choosing the Right Predicate Device: Apples, Oranges, or Something in Between? How do you go about choosing the right predicate device? Say you've developed a new tree-borne fruit and you need to In category: FDA Approval LinkedIn Regulatory Quality
Deregulation of Medical Devices: Say It Ain’t So! You KNOW your proposed deregulation of medical devices is a bad decision when even the device manufacturers ask you to In category: FDA Approval LinkedIn
Intended Use or Indications for Use? Can you explain the difference between intended use and indications for use? 🤔 The terms are NOT interchangeable, but In category: FDA Approval Regulatory Quality Submissions
Choosing the Right FDA Pathway for Your Product, Component or Accessory Choosing the right FDA pathway for your product is not easy and can be fraught with regulatory landmines. But by asking In category: FDA Approval Regulatory Quality Videos
FDA Approval of Your Medical Devices: There’s No Escaping It, Might as Well Accept It Acceptance: The Fifth Stage of Regulatory Grief (video) Let's face it - no one likes being told what to do, and In category: FDA Approval Videos
Regulatory Depression? Bad Design Controls are to Blame Regulatory Depression? Blame Bad Design Controls (Video) The regulatory submission process can leave most anyone In category: FDA Approval LinkedIn Regulatory Quality
There’s No Bargaining with the FDA Bargaining with the FDA - or trying to - is the third stage of regulatory grief, but adopting that as your strategy will In category: FDA Approval Regulatory Quality
Understanding FDA Exemptions FDA exemptions can confuse even the most seasoned regulatory specialist, and it can be difficult to know which process In category: FDA Approval Videos