What is the regulatory pathway for a De Novo medical device or IVD? скачать в хорошем качестве

What is the regulatory pathway for a De Novo medical device or IVD?

The FDA has guidance for preparing a De Novo that addresses the format, content, management of the review clock, and user fees. However, there is nothing available from the FDA about planning or strategy. The FDA only recommends requesting a Q-sub meeting before you submit. Since there are only 25 to 30 De Novo submissions each year, few regulatory consultants have enough experience with De Novo submissions to propose a strategy. Our firm recently submitted another De Novo, and we have three more that will be submitted before October 1. In the past, we would always submit a pre-submission to the FDA. However, our strategy has changed recently. The reason for our change is that the FDA frequently responds to questions in a pre-sub about the De Novo pathway by saying, "We recommend that you submit a 513(g) to determine the regulatory classification of your device." This feedback is discouraging if you have spent four months waiting for a pre-submission meeting teleconference. Now the FDA wants you to prepare a 513(g) submission, pay a user fee for the 513(g), and wait another 2+ months waiting for a 513(g) classification request response. In order to prevent this additional 2+ month delay, we are now recommending that companies submit a 513(g) first, and then submit a pre-submission meeting request immediately after the 513(g) submission (i.e., about one week after the 513(g) submission). By submitting the pre-submission in parallel with the 513(g) you can reduce the waiting time. By submitting the 513(g) first, by a week, you will now have a "C number" you can reference for the FDA decision regarding the classification of your device. In your pre-submission meeting request, you can ask other questions not related to the classification: questions about your clinical study protocol questions about a human factors / summative usability study questions about statistical sample sizes questions about the selection of the "worst-case" sample for testing For your eventual De Novo submission there will be four items that are different from a De Novo. ➤    • De Novo vs 510k - What’s the difference   Your 513(g) can include one or more of these four items as supporting evidence for why you believe your device is a De Novo instead of a 510(k). How can you accelerate the De Novo process? 1 - You can submit a Breakthrough Device Designation request 2 - You can submit a STEP request 3 - You can prepare and submit a device master file (MAF) If you have other questions about your potential De Novo submission, please schedule a call with us: https://calendly.com/13485cert/30min