If you are planning to submit a 510(k) for your medical device to the FDA, you should know that the FDA has tightened their expectations. Consequently, it is more important for you to become familiar with current Refuse to Accept (RTA) policy. Rather than assessing 510 (k) actual contents, the RTA’s purpose is for the FDA to quickly review your submission for completeness.
Following a checklist included in the RTA guidance document, the initial reviewer looks through your 510(k) notifying you of acceptance or rejection within 15 days of submission date. Accepted submissions move forward while rejections come with a completed check list and comments on deficiencies.
Here is some advice to expedite FDA 510(k) submissions:
When you are formulating your submission, use the RTA checklist to your advantage filling it out referencing where you address each specific question within the 510(k). When you submit the 510(k) paperwork, include your version of the checklist.
Before you submit the 501(k), complete all your sterilization validation and electrical safety and biocompatibility testing including protocols, results and reports. Contrary to leveraging current biocompatibility data on similar materials and processes, submitters must incorporate biocompatibility testing specific to the medical device and combination of processes and materials.
To avoid resubmission, provide all performance test protocols, test data and results because the FDA no longer accepts summaries.
In their submission review, the FDA wants to make sure that you have adequately proven the safety and effectiveness of your device. To speed up device approval, use the same standards and test methods to test directly against the predicate medical device providing the FDA with very detailed information proving that your device is substantially similar to the predicate. Make sure that your device labeling for precautions, warnings, indications and contraindications matches the labeling for the predicate device.
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