The Time FDA Actually Withdrew a Warning LetterThe Time FDA Actually Withdrew a Warning Letter

You'd be hard pressed to find any examples before or since, but there is at least one case in medtech history in which FDA officially withdrew a warning letter to a medical device manufacturer.

It all started with a controversy that arose from an FDA inspection at Laerdal Manufacturing in May 1993, according to an MD+DI article by former regulatory affairs columnist James Dickinson. The inspection resulted in a preliminary injunction suit citing the company for good manufacturing practices (GMP) violations. FDA lost that suit but turned around and issued a warning letter in September 1994 alleging that Laerdal was marketing unapproved devices.

The company's lawyer, Larry Pilot (now retired but continues to advise companies on FDA compliance matters), replied to the warning letter with a unique petition citing Laerdal's court win and seeking to assert the doctrine of res judicata, the civil court equivalent of double jeopardy. FDA granted most of the petition but declined to formally withdraw the warning letter. In a follow-up letter in August 1995, Pilot insisted on the withdrawal, and FDA finally buckled about a month later.

In a letter written by Ronald Chesemore, who served at the time as FDA's associate commissioner for regulatory affairs, the agency admitted that the September 1994 warning letter to Laerdal was not warranted.

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Getting FDA to essentially take back a previously issued warning letter was a first to Pilot's knowledge at the time and remains a unique situation to this day.