5 Alternatives When You Can’t Find a Predicate Device
This is a huge mistake!
There may only be one predicate device, or there may be hundreds of predicate devices. If your device has multiple intended uses, you might even have to choose between predicate devices with different classification codes.
The selection of a predicate device is your most important decision, because the FDA will compare your device submission with the 510k submission for the predicate device. If you are not sure what performance data was submitted to the FDA, you may have a very unpleasant surprise after about 60 days–if not sooner.
This presentation will review the process for identifying a predicate device. The first part of this presentation includes strategic considerations for selection of a predicate device. This will suffice for most 510k submissions, but companies developing new technology are often unable to find a suitable predicate device. In this case, you have five options:
- Conduct a Clinical Study and Prepare a PMA Submission = $$$ + 2 years min.
- Prepare a DeNovo Submission = 120 days instead of 90 days
- Submit a 510k with Your Best, Poor Choice & Expect One of Two Responses: Refusal to Accept (RTA) or Not Substantially Equivalent (NSE)
- Request a Pre-Sub Meeting with the FDA = 60-day Delay at Front of Project
- Submit a 513(g) Request to the FDA = $ + 60-day Delay at Front of Project
510(k) Medical Device Academy Training Overview – Brief Video
- When: Thursday, June 4, 2015
- Time: 9:00 AM Eastern Time
Who should watch?
- Regulatory Affairs
- Product Development / R&D
You will be able to ask questions during this live webinar session. You will also receive a link for downloading the recording of the webinar.
In our live webinar we will review each of the five alternatives and explain the advantages and disadvantages of each. Two case study examples are also provided that will help you choose the best approach for your company. At the end of the webinar, you will have the opportunity to ask questions live.
If you can’t make the live session, register anyway and submit your questions to me by email. You will still receive a recording of the webinar and a copy of the native slide deck.
Please Note: Purchase of the webinar includes the native PowerPoint slide deck and the recording of the webinar. You will have the ability to share this content with anyone in your company—as many times as they wish.
About Your Instructor
Robert Packard is a regulatory consultant with 20 years experience in the medical device, pharmaceutical and biotechnology industries. He is a graduate of UConn in Chemical Engineering. Robert was a senior manager at several medical device companies—including President/CEO of a laparoscopic imaging company. His Quality Management System expertise covers all aspects of developing, training, implementing, and maintaining ISO 13485 and ISO 14971 certification. From 2009-2012, he was a lead auditor and instructor for one of the largest Notified Bodies. Robert’s specialty is regulatory submissions for high-risk medical devices, such as implants and drug/device combination products for CE marking applications, Canadian medical device applications and 510(k) submissions. The most favorite part of his job is training others. Specialties: CE Marking, Canadian Medical Device Applications, Post-Marketing Activities, Supplier Quality, CAPA, Risk Management, Auditing, Sterilization Validation, Lean Manufacturing, Silicone Chemistry, Extrusion, Bioprocess Engineering, and Strategy. He can be reached via phone 802.281.4381 or email. You can also follow him on Google+, LinkedIn or Twitter.