Letter-to-file 101: Are You Sure You're Preparing Yours Correctly?

Imagine this scenario: FDA knocks on your door.  They say you changed your medical device, but you did not tell them first.  What would you do? 

Unlike in the drug world, medical device companies make changes to existing devices all the time. Sometimes they tell FDA, other times they don’t.  And sometimes they get in trouble for making the wrong decision! 

So how do you decide when to handle a change internally (via a letter-­to-­file) vs. when to notify FDA with a special 510k or PMA supplement? The choice isn’t always clear. And if you choose the LTF option, what exactly does that mean?

Given a choice, every medical device company on earth would like to market their device without going through FDA first. But most of the time they can’t do that.

And once the device is on the market, every medical device company on earth would like to be able to make changes to their device without going through FDA.

The letter-to-file is usually the path that's chosen, even though there is no FDA guidance or template for an LTF that manufacturers can follow.

Register for this free in-depth webinar presented by regulatory expert Michael Drues, President of Vascular Sciences, to learn the right way to prepare a letter-to-file… It may be the only thing that stands between you and a FDA warning letter or worse!

Watch the webinar

Greenlight Guru-M. Drues Webinar 3-24-22
Specifically, this webinar will cover:
  • What is a LTF and when / how should it be used?
  • What goes into a LTF? What should it contain?
  • How does a LTF compare to a special 510k or PMA supplement?
  • Can a LTF be used for a class III PMA device?
  • Is the LTF faster and/or less burdensome than notifying FDA?
  • If you get sued, how can a LTF be used against you?
Who Should Attend?
  • Quality Professionals and Management
  • Regulatory Affairs Professionals and Management
  • R&D Engineers and Management
  • Medical Device Executives
Register Now  

Hosted by

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

President, Vascular Sciences

Moderator: Etienne Nichols

Medical Device Guru & Community Manager,

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 tolearn 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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