MDR Reporting – FDA Appears to Disavow The Two Year Presumption

February 14, 2012

By Jeffrey K. Shapiro

This post is the second in an occasional series that will examine significant or interesting warning letters involving medical device companies. 

As a reminder, FDA issues warning letters to allege violations of the Federal Food, Drug, and Cosmetic Act and/or implementing regulations.  A warning letter is a statement of FDA’s enforcement position and a threat to pursue legal remedies if the target does not comply.  On occasion, FDA issues a warning letter that reveals a new or little known enforcement position.  This type of warning letter will be our critical focus.

On December 27, 2011, the Philadelphia district issued a warning letter focused on Medical Device Reporting ("MDR") issues. 

This warning letter has a fascinating comment about the presumption that a malfunction is likely to contribute to a serious injury or death if it were to recur.  Essentially, FDA criticizes the target company for following the agency’s own written guidance on this issue.

As background, under the MDR regulation, a malfunction is reportable if a recurrence would likely cause serious injury or death.  21 C.F.R. § 803.50(a).  The question is, if a malfunction actually causes a serious injury or death, must the manufacturer presume that subsequent occurrences of the malfunction are “likely” to do so as well?  In 1997 guidance, FDA said:

“FDA believes that once a malfunction has caused or contributed to a death or serious injury, a presumption that the malfunction is likely to cause or contribute to a death or serious injury has been established. This presumption will continue until the malfunction has caused or contributed to no further deaths or serious injuries for two years, or the manufacturer can show, through valid data, that the likelihood of another death or serious injury as a result of the malfunction is remote.”  (Emphasis added.)

The target of the warning letter apparently had incorporated the foregoing “two year presumption” in its warning letter procedure.  FDA did not approve.  The warning letter admonishes:

Also, your firm states in [redacted] that malfunctions causing or contributing to a death or serious injury will be reported to FDA until the malfunction has not caused or contributed to further deaths or serious injuries for two years. The guidance document “Medical Device Reporting for Manufacturers,” dated March, 1997, contains a discussion of malfunctions and reportability. The guidance advises that malfunctions should be reported until valid data shows that the likelihood of another death or serious injury occurring as a result of the malfunction is remote and references a two year period. The guidance is intended to assist industry with interpreting the requirements of the MDR regulation, 21 CFR Part 803. However we currently recommend that manufacturers who wish to stop reporting a malfunction contact the MDR Policy Branch for further discussion at 301-796-6670 or by email at

Stepping past the District's misleading characterization of the guidance document, the warning letter is troubling on two levels.  First, it appears that FDA is disavowing the “two year presumption.”   Apparently, FDA now wishes to adjudicate the expiration of the presumption on a case by case basis.  This policy change is unfortunate.  The two year presumption has been a rare “bright line” rule among a welter of MDR reporting elements that are mostly subjective and difficult to apply in the real world.  It has been in place for 16 years with no apparent ill effect.  The decision to now require case by case adjudication of the presumption will increase the cost and uncertainty of MDR reporting.  There does not seem to be an obvious benefit to doing so.

Second, many firms have relied upon FDA’s published guidance to incorporate the two year presumption in their MDR procedures.  To our knowledge, FDA has not publicly modified the guidance.  Therefore, it seems reasonable for firms to rely upon the guidance in formulating their MDR procedures.  Yet, the warning letter suggests that firms are no longer safe in doing so. 

It is arbitrary and capricious for an administrative agency to modify published guidance via individual warning letters.  This is the opposite of transparency.  If FDA wishes to alter the two year presumption, it should follow its own Good Guidance Practices.

The terminology of the warning letter creates even more confusion.  It couches the directive to consult the MDR Policy Branch as a “recommendation.”  So, is it now violative to have a two year presumption in an MDR procedure, or not?  Must firms proactively revise their procedures?  Or should they simply wait until an inspector criticizes the procedure or issues a Form 483 observation?  Perhaps this enforcement position is unique to the Philadelphia district?  It is hard to know.

What we do know is that this warning letter has taken the helpful certainty of the two year presumption and thrown it to the wind.

REMINDER: HP&M is hosting FDA Appeals – Improving Your Odds of Success: Trends, Expectations, Strategies, a webinar on March 21, 2012, 12:30 – 2:00 p.m. ET.  Click here to register.

Categories: Medical Devices