In many cases, company officials don’t do some initial investigation before making the decision, according to Vascular Sciences President Michael Drues, who has about 25 years experience in medical device regulatory matters.
Drues thinks this industry practice is regrettable and has caused much of the trouble medical device companies find themselves in with FDA.
“Do a little bit of an analysis, do a little bit of an investigation first, and then make a decision about what you do with that information,” Drues said.
The truth is that a letter-to-file is not a shortcut, according to Drues. “You do have to do that investigation of whatever change or changes you’re making here to determine whether those changes are going to affect safety, efficacy, performance or so on.”