Adverse Event Reporting for Medical Devices and the Law: Where Has FDA Gone Wrong?

On September 27, 2007, President George W. Bush signed into law H.R. 3580, the Food and Drug Administration Amendments Act of 2007 (“FDAAA”).  FDAAA both enhances and curtails FDA’s authority in many respects.  Specifically, FDAAA removes a requirement that  manufacturers of Class I devices and Class II devices that are not permanently implantable, life supporting, or life sustaining submit individual malfunction reports to FDA under 21 C.F.R. Part 803.  To date, FDA has not put as much effort into complying with this element of FDAAA as it has with those portions of the law that enhance its own authority.

Prior to FDAAA’s enactment, the Federal Food, Drug, and Cosmetic Act (FDCA) required manufacturers of all classes of devices to regularly report individual device-related adverse events that meet the definition of a “MDR reportable event.” MDR reportable events include, among others, instances where a device has malfunctioned in a way that would be likely to cause or contribute to a death or serious injury if the malfunction were to recur. 21 C.F.R. § 803.3.  As not all device malfunctions are considered an MDR reportable event, manufacturers must evaluate each malfunction to determine if it is reportable.

To comply with the malfunction event reporting requirement, all medical device manufactures are supposed to establish systems and procedures for monitoring and evaluating product complaints and other forms of device performance feedback from the field on an ongoing basis to identify, investigate, and report device malfunctions meeting the definition of an MDR reportable event. Moreover, this process must be completed within a specific timeframe dictated by the agency, and FDA focuses significant enforcement attention on compliance with these requirements.  As a result, maintaining a compliant MDR system can cause a significant burden on the part of manufacturers.

FDAAA did away with the traditional malfunction event reporting requirement for manufacturers of Class I devices and Class II devices that are not permanently implantable, life supporting, or life sustaining.  Instead, these manufacturers are required to submit summary reports to be made on a quarterly basis.  FDCA § 519(a)(1)(B)(ii).  FDAAA included with the above change a provision to allow FDA to retain regular per-event reporting standard for certain devices only if FDA provides notice that such devices would continue to be subject to 21 C.F.R. Part 803 “in order to protect the public health.” FDCA § 519(a).

If a manufacturer never read § 519, it would have no reason know that anything has changed.  FDA never issued notice contemplated by Congress.  Instead, FDA issued a Federal Register Notice that, until it provides further notice, all classes of devices need to comply with Part 803 “in order to protect the public health.”  See 76 Fed. Reg. 12743 (Mar. 8, 2011).  More recently, FDA still indicated that it will provide such a list, but gave no indication of when such a list will be published.  CDRH, FDA, Draft Guidance For Industry and Staff: Medical Device Reporting for Manufacturers (July 9, 2013).

Although this issue has not drawn much attention, it is questionable whether FDA has authority to enforce its current policy that requires all manufacturers of all device classes to report malfunctions on a per-event basis. Clearly FDA has enforced this broader policy against device manufacturers to which Congress intended to provide relief.  See e.g. FDA Warning Letter to Church & Dwight, Inc. (May 16, 2011). Administrative agencies are allowed deference in certain circumstances in interpreting and administering a statute.  However, a court “must give effect to the unambiguously expressed intent of Congress,” pursuant to Chevron, U.S.A. v. Natural Res. Def. Council, Inc., 467 U.S. 837, 842-43 (1984).  Here it is clear that Congress intended that certain Class I and II device manufacturers would be exempt from reporting malfunctions on a per-event basis.  It is also clear that Congress allowed FDA authority to create an exception for certain devices.  However, FDA’s current policy, which has been in effect for approximately six years, clearly flies in the face of Congressional intent.

It is interesting that FDA has effectively ignored the §519 provision in a time where FDA pleads for more government dollars due to a lack of resources.  Instead, it appears that FDA, for the foreseeable future, will continue to enforce individual malfunction event reporting for all and continue to maintain a burden on itself and the industry that Congress does not believe is necessary.

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