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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!