Free the FDAAA Hostage!

By Jeffrey K. Shapiro –

There has been a lot of talk about hostage taking during the recent federal government budget impasse.  But Congress is not the only one taking hostages in Washington.  The recent draft Medical Device Reporting (MDR) guidance reminds us (pp. 4-5) about a long forgotten hostage moldering in FDA’s statutory implementation dungeon. 

To be specific, Section 227 of the Food and Drug Administration Amendments Act of 2007 (FDAAA) amended Section 519 of the Federal Food, Drug, and Cosmetic Act (FDCA) to ease the burden of malfunction MDR reporting by requiring only summary quarterly reporting for most class I and II devices.   

Congress directed that revised malfunction MDR reporting shall be “in accordance with criteria established by [FDA] for reports … which criteria shall require the reports to be in summary form and made on a quarterly basis.”  519(a)(1)(B)(ii).  

This change does not apply to class III devices, class II devices that are permanently implantable, life supporting, or life sustaining, and such other devices as FDA may designate in a “notice published in the Federal Register or letter to the person who is the manufacturer or importer of the device.”  Section 519(a)(1)(B)(i)(III).

Unfortunately, a full six years has passed, and nothing has happened.  In 2011, FDA issued a notice reminding industry that malfunction MDR reporting should continue as usual.  76 FR 12743.  In 2013, FDA has now reminded everyone again in the draft MDR guidance that nothing has changed.

Interestingly, the FDAAA Implementation Chart on FDA’s website does not even show the malfunction MDR reporting change as an item intended for implementation.  There should be a row for Section 227, but the chart skips from Section 226 to 228, with not a word about implementation of Section 227.  

Is this long delay really necessary?  According to the federal register notice, FDA is delaying implementation of the quarterly MDR reporting change until:

1. The agency publishes a federal register notice listing the additional class I and II devices not eligible for quarterly reporting pursuant to Section 519(a)(1)(B)(i)(III) of the FDCA; and
2. The agency conducts a rulemaking to establish the criteria for summary quarterly reporting for most class I and II devices pursuant to Section 519(a)(1)(B)(ii) of the FDCA.

Thus, implementation of the change is being held hostage to the agency’s own inaction.

As to the first item, Section 519(a)(1)(B)(i)(III) was intended to give FDA the regulatory flexibility to designate additional devices ineligible for quarterly reporting.  Nothing in the statute indicates that FDA’s designation of a complete list of such devices is a threshold requirement for implementation of quarterly reporting.  FDA’s failure to issue this list is not a valid basis for holding up implementation of quarterly reporting for the majority of class I and II devices.

As to the second item, keep in mind that even when FDA finally initiates a rulemaking, it typically takes several years until a final rule is issued.  With no rulemaking even begun, FDA appears on track to exceed 10 years in implementing this simple statutory requirement.  This delay is unacceptable.

Furthermore, the statute merely says that quarterly reporting shall be under criteria to be “established” by FDA.  The word “established” does not require a rulemaking, but could be achieved by a guidance.  Given the six year delay, at this point, it would be prudent for FDA to issue a guidance.  Even that process would probably require one to two years.  A benefit to issuing a guidance would be to allow FDA to gain some experience with widespread quarterly reporting before codifying  the requirements in a regulation.  It would also allow the agency to actually implement quarterly reporting inside of a decade.

By the way, Section 226 of FDAAA amended Section 519 to require FDA to establish a system of unique device identifiers.  This provision directs FDA to “promulgate regulations establishing a unique device identification system.”  Thus, Congress knew how to direct FDA to initiate a rulemaking when one was desired.  The absence of a similar requirement to “promulgate regulations” in Section 227 bolsters the interpretation that Congress did not intend for FDA to conduct a rulemaking to establish criteria for quarterly summary MDR reporting.

Congress has made the judgment that quarterly malfunction MDR reporting is sufficient to protect the public health for most class I and II devices.  Six years later, it is long past time for FDA to let this hostage go.