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UPDATE: NEW FDA DRAFT GUIDANCES FOR 510(k) PRODUCTS

By: Mark Swanson, QRxPartner




Planning to contact the FDA to get your product cleared?!? This process is often like looking through a glass of muddy water.






This last week, Dr. Jeffrey Shuren (CDRH Director) was touting three new draft guidance intended to modernize the 510(k) program.


The first involves best practices for choosing a predicate device (who are you comparing yourself to??). Selecting a predicate device would be transparent and improve the safety and effectiveness of devices with the advances in security and other innovations. These best practices will assist manufacturers in the selection process to move forward with that ideal.


The second draft guidance clarifies when clinical data is needed to demonstrate substantial equivalence. Often, manufacturers get surprised when the agency doesn't grant the clearance due to differences in technological characteristics (new materials or other innovations). This guidance provides greater transparency to support the FDA's thinking to ensure submitters provide appropriate data to support the substantial equivalence determination.


The final draft guidance issued this last week is on implant performance testing requirements. This provides updated recommendations for device manufacturers on the design and performance testing for 510(k) implantable devices and the content and labeling information to include with the submission to the FDA.




All of this is being done alongside the requirement to use the eSTAR system for making those submissions that are required after October 1st.


Please contact QRx Partners for help implementing these best practices to move your product toward market release!!


833-779-7278

LinkedIn @QRxPartners


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