3 DRAFT GUIDANCES: Keeping in Step with the 510(k) Medical Device Program Modernization

Oct 12, 2023 | White Paper |

It can be hard to keep up with FDA’s latest regulatory intelligence, trust us, we know!  When we say STOP, save these 3 guidance documents and sign up for FDA’s webinar please listen. 

Best Practices for Selecting a Predicate Device to Support a Premarket Notification [510(k)] Submission

Recommendations for the Use of Clinical Data in Premarket Notification [510(k)] Submission

Evidentiary Expectations for 510(k) Implant Devices

They will be essential in your 510(k) drafting, but if you don’t have the time to read cover to cover, this white paper will get you started!

Follow the link below to save the calendar invite to the webinar CDRH's New Draft Guidances to Continue to Modernize the 510(k) Program[4] on October 26, 2023 from 1:00pm to 2:30 pm ET!

Webinar – CDRH's New Draft Guidances to Continue to Modernize the 510(k) Program – 10/26/2023 | FDA

Do you have questions about drafting your 510(k) or what these three new guidances entail? MEDIcept has regulatory experts who are ready to help. Contact us today at sales@medicept.com to learn more!

Click to read the latest MEDIcept White Paper!