What are your proposed FDA Special Controls for a De Novo?

This webinar shows you how to recommend FDA special controls to address risks to safety and to ensure performance for a De Novo application.

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FDA Special Controls 300x297 What are your proposed FDA Special Controls for a De Novo?

What are your proposed FDA special controls for a De Novo? ($49)

This webinar will teach you how to propose appropriate FDA special controls for your subject device in a De Novo Classification Request. You might think that you need to read the FDA guidance on how to write a special controls guidance. However, the FDA no longer writes a Special Controls guidance document for new device regulations. Instead, the FDA includes the special controls directly in the new device regulations. The first part of the regulation identifies the regulation name and number. The second part of the regulation describes the intended use and describes the technological characteristics of devices in the scope of the new regulation. Finally, the last second lists the requirements for special controls. The purpose of those special controls is to verify and validate that each risk control recommended in the risk mitigation table for the new device regulation has been addressed.

FDA Special Controls What are your proposed FDA Special Controls for a De Novo?
What are your proposed FDA Special Controls for a De Novo?
This webinar will teach you how to propose appropriate FDA special controls for your subject device in a De Novo Classification Request. You might think that you need to read the FDA guidance on how to write a special controls guidance. However, the FDA no longer writes a Special Controls guidance document for new device regulations. Instead, the FDA includes the special controls directly in the new device regulations.
Price: $49.00

Please note: These products will be delivered to the email address provided in the shopping cart transaction. After the transaction is verified, please check your email for the download.

When is the FDA special controls webinar?

This webinar will be live on Thursday, July 25, 2024 @ 10:30 am ET. The session will also be recorded. You can purchase it on-demand and watch the training as often as you wish. If you need help preparing your FDA eSTAR submission, we offer a standard fee for De Novo submissions or we can help you on an hourly basis. 

What you will receive in the FDA special controls webinar:

In this training you we learn how to FDA find special controls guidance documents and where to find special controls for newer regulations that do not have a stand-alone guidance document. We will also provide you with multiple examples of special controls for a variety of risks that were discussed in our risk mitigation table webinar for De Novo applications.

  • Native Slide Deck
  • Recording of the Webinar (download and watch again and again)
  • Login credentials for the live webinar if you purchase on or before July 25, 2024

If you would like to upgrade your purchase to our entire 510(k) Course, which includes templates and webinars for pre-submissions, 513(g) Classification Requests, 510(k) submissions, and De Novo applications, please contact Lindsey Walker and she will provide you with a quote that includes a credit for your purchase of this webinar.

About Your Instructor

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Rob Packard is a regulatory consultant with ~25 years of experience in the medical device, pharmaceutical, and biotechnology industries. He is a graduate of UConn in Chemical Engineering. Rob was a senior manager at several medical device companies—including the 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 certifications. From 2009 to 2012, he was a lead auditor and instructor for one of the largest Notified Bodies. Rob’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. He can be reached via phone at +1.802.281.4381 or by email. You can also follow him on YouTube, LinkedIn, or Twitter.

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