Medical Devices Group

  • Community
  • Webinars
  • Jobs
  • Events
  • Contact
  • Go Premium
« Back to Previous Page
like 3 comments  share
Rob Packard
Ship & Print Your FDA eCopy
November 2016
What do you do when your testing data is not quite good enough?
2 min reading time

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
++++++++++++++++++++++++++++++++++++++++++++++++++++++++
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

Marked as spam
Posted by Rob Packard
Asked on November 9, 2016 12:00 am
61 views
  • Follow
  • Unfollow
  • Report spam
like 3 comments  share

Meet your next client here. Join our medical devices group community.

Private answer
Rob Packard Sorry about that...last few words were "...not a perfect submission."
Marked as spam
like
  • Report spam
Private answer
Kiran SM Robert Packard, I thank you for this LinkedIn post. It summarizes the options if testing data is inadequate for submission in a succinct manner.
Marked as spam
like
  • Report spam
Private answer
Chuck H. Mograbi It is really simple. You have to determine if the data issue is related to testing issue such as testing instruction, operator's error, equipment not being validated or calibrated , or a design issue.
Mini tab software can find this for you very easily and tell you if it is operator errors, equipment or a design problems.

If it is an operator error, you have to write your rational, make the appropriate correction and repeat the test.
If it is a design problem, you really have to go back to your design control and start over.
Taking too long to repeat the test?
Time is irrelevant to FDA, this is not valid argument to present.


Marked as spam
like
  • Report spam
« Back to Previous Page
Ask a Question
Leave a Comment

We still use LinkedIn to access our site because it’s the only way to “pull in” your LinkedIn photo, name, and hyperlink to your profile page, all vital in building your professional network. When you log in using LinkedIn, you are giving LinkedIn your password, not me. I never see nor store your LinkedIn credentials.

Stay connected with us.

By signing up you are agreeing to our Privacy Policy.

Categories

  • Capital/Investment
    • Business Model
    • Funding
  • Careers
  • Design/Devel
    • Design
    • Development
    • Human Factors
    • Labeling
    • Material Selection
    • R&D
    • Trials and Post-Market
  • Featured
  • Industry
    • Announcements
    • Device Tax
    • Hospital and Health Care
    • Innovation
    • Medtech
  • LinkedIn, etc.
  • Markets
    • Africa
    • Americas
    • Asia
    • Australia
    • Europe
  • Regulating
    • CE Marking
    • EU
    • FDA
    • FDA/EU etc.
    • Notified Bodies
    • Quality
    • Regulatory
  • Selling
    • Distribution
    • Intellectual Property
    • Marketing/Sales
    • Reimbursement
  • Worth bookmarking!
Feature your job here.
logo

Companion to LinkedIn's 350,000 member community

  • Contact
  • Medical Device Marketing
  • In Memoriam
  • Medical Device Conference

The Medical Devices Group   |   Copyright © 2025 Terms, Conditions & Privacy

Medical Devices Group
Powered by  GDPR Cookie Compliance
Privacy Overview

This website uses cookies so that we can provide you with the best user experience possible. Cookie information is stored in your browser and performs functions such as recognising you when you return to our website and helping our team to understand which sections of the website you find most interesting and useful.

Strictly Necessary Cookies

Strictly Necessary Cookie should be enabled at all times so that we can save your preferences for cookie settings.

If you disable this cookie, we will not be able to save your preferences. This means that every time you visit this website you will need to enable or disable cookies again.