Special Controls: What Are They & How Can We Use Them To Our Advantage?

According to the FDA, 43% of medical devices are Class II and over one-third of all Class II devices require “special controls.” 

CDRH lists 126 special controls on their website, but what are special controls and what’s “special” about them? 

FDA describes Special Controls as specific guidance for Class II devices. But is that an overly myopic connotation of special controls? Can special controls be used for Class I devices? For class III devices? In short, absolutely yes! And are special controls limited to “specific guidance?” Not at all!

Obviously, if special controls apply to a particular device, the manufacturer has an obligation to know what they are and to prove to FDA that their device meets them. 

However, special controls are one of the best ways to make it more difficult for competitors to use your device as a predicate (called competitive regulatory strategy) in their 510(k), yet few manufacturers use special controls to their competitive advantage. 

Given a choice between 510(k) vs. de novo, could the possibility of imposing new special controls on your competition to create a barrier push you in the de novo direction? A manufacturer would be naive to not consider this option!

Watch the webinar

Greenlight Guru-M.Drues Webinar 5-19-22
Specifically, this webinar will discuss special controls in detail including:
  • What are special controls? When and how are they used?

  • Why do we call them “special” controls? Are they really “special?”

  • What’s the difference between general controls and special controls? When and why do we need both?

  • How do you know if your device requires special controls? How can you find out?

  • For Class II exempt devices, do special controls still apply?

  • How do special controls vary in a 510(k) vs. in a de novo?

  • Virtually all special controls are intended to ensure safety, but can special controls address efficacy?

  • When should an existing standard for a special control be used vs. when to create a new standard?

Using the case study approach, regulatory expert Michael Drues, Ph.D., President of Vascular Sciences, will present detailed explanations to all of the above questions and more during this interactive webinar.
If you're working on a medical device involving special controls – and you probably are – you won’t want to miss this important webinar!

Who Should Attend?

Geared for both experienced medical device professionals as well as those new to the industry, this webinar is designed for those who need a better understanding of the regulatory requirements necessary to bring medical devices to market.

Personnel working in the following disciplines will find this course particularly useful:

  • Regulatory Affairs Professionals

  • QA/QC Personnel

  • Design and Development Engineers and Technicians

  • Product and Product Development Management

  • Medical Device Executives

  • Scientists

Additionally, investment/ acquisition specialists and field service engineers will all benefit from this webinar.

Register Now  

Hosted by

M.Drues Headshot circle (3)
Presenter: Mike Drues

President, Vascular Sciences

Jon Speer
Moderator: Jon Speer

Founder, Greenlight Guru


About Vascular Sciences

Vascular Sciences has been conducting seminars specifically geared toward medical device design, development and testing since 1996. These seminars have been requested by companies ranging in size from start-up to fortune 100 companies, the European Patent Office and the FDA Centers for Devices and Radiological Health (CDRH). Visit their website to learn more.


About Greenlight Guru

Greenlight Guru is the only Medical Device Success Platform (MDSP) for companies to bring new products to market faster while simplifying regulatory compliance and reducing risk. Being the only industry specific, cloud-based software, Greenlight Guru is easier to implement, easier to use and designed to fit all medical device needs to enable innovative, safe and effective, True Quality medical devices. Visit our homepage to learn more.

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