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Congress recognized that FDA struggles with software regulation. So, Congress removed some software out of FDA's jurisdiction. Now FDA must revise its premarket and postmarket software regulatory approach, including mobile apps. Using voluntary standards in premarket submissions can be used more effectively. Even more dramatic, FDA's new Digital Health initiative turns FDA's premarket clearance program on its head.
It is not about giving an OK to products, it is about trusting the manufacturer to do the right thing. Overall, your regulatory approach to software regulation needs to ease up and reap the benefits where they apply. Your company may even save money, a nice benefit.
Why should you Attend: FDA's regulation of software provides major relief to firms involved with software, especially low risk software. The scope of your program should be re-evaluated to identify your least burdensome approach. You can learn what matters and what does not. You can implement faster ways to move products into the marketplace and decide whether or not you want to involve FDA in your cybersecurity problems. You can prepare now to qualify for the new Digital Health initiative, but you have homework to do first.
Areas Covered in the Session: