If you have testing data for safety and performance, but the data does not meet the current requirements for a submission, what should you do?
For Europe, companies are required to update their technical documentation and retest when appropriate. If they don’t retest, then a justification for the acceptability of the existing data must be provided. Unfortunately, what your Notified Body auditor will accept today might not be accepted tomorrow.
If you have CE Marking and you are planning a 510(k) submission you need to know if your rationale is sufficient. The most conservative answer is to simply retest to the newest standard. Ultimately you may have to do this anyway. However, retesting and waiting for the results takes time and money.
Another option is to submit a pre-submission request to the FDA and ask the question. In this case, probably requesting an email response will result in the most information from the FDA. If you elect for a teleconference or a face-to-face meeting you are limited to one hour of time to get feedback. If you elect for an email response, the participants providing feedback can each compile their response in the one hour and the combined input will be greater than a group meeting would provide. This approach is also free. The only cost is waiting for the response. I recommend this approach, because there are often unanticipated delays that affect submissions. You typically have a response from the FDA before you are ready to submit.
Option number three is to review previous 510(k) submissions that are available through the new Redacted FOIA 510k database. These are full 510ks that you can download from the FDA website for FREE in seconds. I have already downloaded a couple hundred as part of my own research efforts. Check out my new webinar: http://medicaldeviceacademy.com/redacted-foia-510k-webinar/. I also posted a new blog on the topic today: http://medicaldeviceacademy.com/redacted-510k/.
A fourth option is to consult with someone that has submitted a 510(k) previously for a similar device. If you review previous 510(k) summaries, you will be able to find several consultants that have significant experience with the type of device you are working on. They may have encountered a similar situation and they may have suggestions for the wording of your rationale or identify better ways to get the data you need for your submission.
Sometimes you don’t even need the data you thought you needed. Therefore, it’s always a great idea to ask testing labs and other consultants for advice—in addition to considering a pre-submission meeting request.
Finally, remember that your goal is regulatory clearance—not a
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I have four new webinars to announce this week:
1. 510(k) Cover Letter & FDA Form 3514 – I recorded this short webinar Sunday and I will email templates with the slide deck and the recording. The cost is $29. The webinar is available for download at: http://medicaldeviceacademy.com/510k-cover-letter/.
2. 510(k) Boilerplate – This webinar was recorded yesterday (Tuesday morning). This webinar is FREE if you submit a question: http://medicaldeviceacademy.com/510k-boilerplate/.
3. 510(k) Declaration of Conformity & FDA Form 3654 – This is planned for next Thursday, November 17. The cost is $49. Here’s the link: http://medicaldeviceacademy.com/FDA-Form-3654/.
4. Redacted FOIA 510k Webinar – This webinar is planned for Monday, November 21. The cost is $79. There is also a new blog about this new FDA database. Here’s the link: http://medicaldeviceacademy.com/redacted-foia-510k-webinar/.
There are new webinars every week, so don’t forget to visit: http://medicaldeviceacademy.com/webinars/.

source: https://www.linkedin.com/groups/2070960/2070960-6202217290100936708