How to Prepare a Medical Device 510(k) Submission for FDA
At $89, it’s like getting Rob Packard’s, Nancy Knettell’s, and Maren Nelson’s advice for $29 an hour – with bonuses thrown in for free! A real bargain.
Note: Once you purchase, you’ll be able to return to your unique link as often as you like. So you can start now, finish later, and return for refreshers, as needed.
“The 510(k) process is not especially difficult. The hardest part of the process is knowing where to find information,” writes Medical Devices Group Advisory Board member Rob Packard.
“For example, you need to know what is required for the format and content. The FDA has a guidance document for that. You need to know what testing is required. The FDA has a special controls guidance for most products. You need to understand how the decision of substantial equivalence is made… there’s guidance for that too. The FDA even has templates on the fda.gov website for many documents required for a 510(k) submission.”
Rob gave a 2.5-hour workshop about 510(k) submissions with Nancy Knettell and Maren Nelson at 10x in May. We’re making the presentation replay, slides, and handouts available online for you today.
The workshop explained the format of a 510(k), how to manage 510(k) projects, and what the requirements are for hardware and software product submissions.
If you have the right testing plan, and you select the right predicate for your 510(k) submission, your submission will go much more smoothly. But if you forget just one piece of testing information, your FDA reviewer will ask for you to send it within 180 days – an almost impossible timeline for samples and testing.
The valuable training from Nancy covered software documentation requirements and preparing software documentation for 510(k) submissions.
Maren Nelson’s presentation covered the definition of “essential performance” for certain electrical medical devices. This is critical, because this must defined and tested for safety and efficacy, so Maren explained what companies need to focus on for electrical safety and EMC testing.
A bonus for subscribers: Rob’s 510(k) table of contents and how to use this simple tool to manage and track 510(k) projects to keep your submission on time.
Many thanks to Rob, Nancy, and Maren for sharing their time and talents with the group.
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