FDA 510(k) Submissions

The right submission to first time approval

It’s not uncommon that 510(k) submissions do not obtain approval upon first attempt. The collective knowledge and experience of the AlvaMed team maintains a proven track record of success upon first submission. All clients benefit from this success supporting their accelerated product market launch.

Confirm your FDA product code, regulation number, and predicate devices. Identifying the correct predicate devices against which you will compare your device is a critical step in the process.

Identify all testing, FDA guidance, consensus standards, and clinical data requirements. While the FDA website contains a wealth of information, the AlvaMed team can cut through the complexities of the guidance and present a clear recommendation for your device.

Prepare a detailed gap analysis report to provide a clear pathway for 510(k) submission. With requirements identified and an assessment of your current documentation complete, we will define the testing and clinical data necessary.

Compile and submit the FDA 510(k) application via the eSTAR template and manage post-submission questions. Once the data and testing results have been assembled, our team will prepare and submit your 510(k) to FDA, and answer follow-up questions that may arise as a result of their review. AlvaMed’s assistance with effective preparation can help speed up the process. 

AlvaMed has helped clients submit many successful 510(k)s across various device technologies.

Our clients are happy to be references – we are happy to share their contact information when you meet with us.

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FDA 510(k) Submissions FAQ's

Start with a search of FDA’s premarket notification database. Search for previously cleared devices with the same product code as the subject device. Then, review the technological characteristics and intended uses that most closely match with your device. Consider a reference device, if needed, to support any differences in technology or test requirements.

With a published goal to clear most 510(k) submissions within 90 working days, the FDA reviewer may request additional information post-submission, which halts their review clock until such information is provided by the submitter.  Taking this into account, the majority of medical devices clear the FDA 510(k) review process in 4-8 months. Simpler devices with limited testing requirements and well-known predicates may be on the short end, while more complex products may on the longer end.  

No, however, the differences in technology cannot raise new questions of safety and effectiveness. Testing can resolve any questions around technology provided established test methods exist. Refer to FDA guidance documents for additional information.

Eric Bannon

Senior Vice President

Eric has completed well over 75 510(k) submissions in his career. He keeps up to date on changing FDA requirements including the recent eSTAR implementation.

Schedule a meeting with Eric to learn how he can help guide your 510(k) submission.