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Introduction

The FDA has proposed an overhaul of the 510(k) clearance system In its release of reports from two working groups, the FDA's goals are to increase the predictability and transparency of the 510(k) process and enhance FDA scientific decision-making. It will also increase the burdens on industry. For example, if finalized, there will be a new subclass of Class 2 products for which clinical studies will be required. You will learn of possible changes in the de novo process that could streamline the clearance process. There will be new definitions of "Substantial Equivalence" and "intended Use" will be redefined and "Indications for Use" eliminated The FDA will likely increase the requirements for the Summary of Safety and Effectiveness and require a summary of all scientific information known or that should be reasonably known to the submitter regarding the safety and/or effectiveness of the device under review. 510(k) submitters would have to provide photographs and design schematics along with detailed device descriptions, which would be available to the public on a revamped 510(k) database. In an attempt to keep up with the rapid pace of innovation in the medical device industry, the FDA plans to issue "Notice to Industry" letters to alert industry to changes in regulatory expectations by FDA for a particular group of devices, plus much more!

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800-447-9407
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