FDA and Industry Push to Reclassify Certain Devices

In 1976, Congress passed the Medical Device Amendments(1) to the Federal Food, Drug, and Cosmetic Act (“1976 Amendments”), which classified medical devices into three risk-based regulatory classes based on the level of control necessary to ensure their safety and effectiveness.  Devices presenting the highest level of risk are classified as class III devices and generally require submission of a Premarket Approval (“PMA”) application providing evidence of the product’s safety and effectiveness prior to marketing.  By comparison, lower risk devices are placed in class I or II and are either exempt from premarket review or are subject to the less rigorous Premarket Notification (“510(k)”) process.

Under the 1976 Amendments, medical devices available on or before May 28, 1976, (“preamendments devices”) and devices similar to them, were distinguished from devices introduced after that date.  Preamendments devices were permitted to remain on the market, without any review by the Food and Drug Administration (“FDA” or the “agency”), pending final classification or other action by the agency.  In its efforts to classify devices following the 1976 Amendments, FDA convened advisory panels according to clinical specialty, each of which was asked to make recommendations as to the classification of devices in that specialty.  Then, in the late 1970s, FDA published a series of proposed rules seeking to classify the devices.(2)  In the proposed rules, FDA published a definition of each device, the panel’s recommended classification for that device, the panel’s rationale, the data relied on in making the recommendation, risks associated with the device, FDA’s analysis of the panel recommendation, and FDA’s proposed classification for the device. 

After public comment, FDA published final rules in the early 1980s that classified many preamendments devices into class II or class III, subjecting them to premarket review.(3)  For those devices placed in class III, FDA was to set a date by which all PMA applications for the newly classified devices must be submitted.  However, in the late 1980s, FDA amended the regulations governing certain preamendments class III devices to note that no effective date had been established for PMAs.(4)  As a result, no PMAs have ever been required for these preamendments class III devices, but FDA also has not reclassified them into class I or class II.  Thus, new devices of these types can still be cleared for marketing through the 510(k) pathway by demonstrating substantial equivalence to a preamendment device even though they are technically class III products. 

With the enactment of the Safe Medical Devices Act of 1990 (“SMDA”), FDA was required (1) to reclassify preamendments class III devices into class I or II, or (2) to issue regulations requiring PMA approval for the devices.  By 2007, the agency still had not fully addressed the requirements of the SMDA.  In response, as part of the Food and Drug Administration Amendments Act of 2007 (“FDAAA”), Congress directed the Government Accountability Office (“GAO”) to conduct a study of FDA’s use of the 510(k) process.(5)  The GAO issued its report in January 2009, which largely focused on preamendments class III devices.  The report lists 20 preamendments device types that were cleared through the 510(k) process between 2003 and 2007 and have not yet been reclassified or subjected to the PMA process, including semi-constrained artificial metal-on-metal hip joints, intra-aortic balloon and control systems, sorbent hemoperfusion systems, and external pacemaker pulse generators.(6)  Noting that three decades have passed since the 1976 Amendments, GAO urged FDA to take immediate steps to address the remaining class III devices that continue to be eligible for 510(k) review.(7)

In response to the report, FDA committed expeditiously to address all remaining class III devices for which 510(k) review is currently permitted.  As a result, the device industry and FDA are rapidly preparing to meet this challenge.(8)  On April 9, 2009, FDA published a notice in the Federal Register stating that the agency has yet to act on 27 types of preamendments devices including those for which no specific clearances were issued during the GAO study period (2003–2007), such as ventricular bypass assist devices, implantable pacemaker pulse generators, and pacemaker programmers (for the full list, see http://frwebgate1.access.gpo.gov/cgi-bin/PDFgate.cgi?WAISdocID=638974222821+0+2+0&WAISaction=retrieve).(9)  In the notice, FDA issued an order requiring manufacturers of 25 of the 27 device types to submit information to the agency, so that FDA can either reclassify or require PMAs for the devices.(10)

Device firms have until August 7, 2009, to submit the required information, which should either support reclassification of the device, or include clinical data supporting the safety and efficacy of the device.(11)  Companies are required to provide any information known or available to them respecting the devices, including any adverse data.(12)  Failure to comply with the agency’s request could subject a company to FDA enforcement actions and, potentially, civil and criminal penalties.(13)  While device firms are scrambling to provide the requested information by the looming deadline, the agency is hiring additional staff to review the incoming submissions.  FDA staff note that many of the remaining preamendments devices are likely to be reclassified, which may result in a large-scale reclassification sometime in the near future.(14)  The agency also notes that it is “committed to getting this right,” such that ultimately devices will be classified as Congress originally intended in 1976.(15)