On April 9, 2009, the U.S. Food and Drug Administration (FDA) required manufacturers of certain device types to submit safety and efficacy information for their devices (74 Fed. Reg. 16214). Devices subject to this mandate consist of twenty-five class III device types that were marketed before passage of the Medical Device Amendments Act of 1976 (Pre-Amendment Class III Device Types). Among the twenty-five types are external pacemaker pulse generators, hip joint metal, and implanted blood access devices. The FDA plans to examine the submitted information to determine whether each device should be re-categorized as low-to-moderate risk Class I or II devices, or whether the risks to patients and users associated with the device are high enough to necessitate that it remain in Class III.
Premarket Review Background
Before medical device manufacturers can market their products in the United States, they must register with the FDA and, depending on the FDA’s classification of the device, it may need to undergo a premarket review process. The FDA classifies medical devices in three categories. Class I devices pose minimal risk to patients and users. They are generally exempt from premarket review. Class II devices pose moderate risks and include such devices as powered bone drills and electrocardiographs. These devices usually need to obtain FDA clearance through the 510(k) process. Finally, Class III devices such as pacemakers and replacement heart valves pose the most serious level of risk and must obtain pre-market approval (PMA) from the FDA before entering the market.
Pre-Amendment Class III Device Types are not required to use the PMA pathway until FDA promulgates a regulation requiring such pathway to be used. Before 1990, the FDA had not made significant progress in promulgating regulations requiring such Pre-Amendment Class III Device Types to use the PMA pathway to gain regulatory approval, and such devices were regularly cleared using the less onerous 510(k) pathway.
The GAO’s Analysis of the FDA’s Premarket Review Process
The FDA’s initiative to reexamine the premarket review process was most likely prompted by a recent report by the United States Government Accountability Office (GAO) (Medical Devices: FDA Should Take Steps to Ensure That High-Risk Device Types Are Approved Through the Most Stringent Premarket Review Process). In its report, the GAO criticized the FDA for failing to reexamine and reclassify the Pre-Amendment Class III Device Types. Its study found that the FDA cleared some of these devices even when it identified them as presenting an unreasonably high risk to public health.
The Safe Medical Devices Act of 1990 had in fact required the FDA to reexamine and reclassify Pre-Amendment Class III Device Types and to establish a schedule to promulgate new regulations requiring those devices that remain in Class III to obtain PMA. The FDA has stated that eventually all Class III devices will require PMA submission. The FDA’s request for information signals that the agency intends to tackle the tasks assigned by the Safe Medical Devices Act.
The Details of the FDA’s Request for Information
Under the FDA’s order, if a manufacturer is aware of any valid scientific evidence supporting reclassification of a device into Class I or II, it may submit either a petition for reclassification, as described in 21 C.F.R. 860.123(a), or the following information:
- A brief narrative identification of the device;
- An identification of the risks to health;
- A statement whether the manufacturer believes the device should be reclassified into Class I or II;
- A summary of the reasons for requesting reclassification;
- An identification of the Class I general controls or the Class II special controls the manufacturer believes are sufficient to provide reasonable assurance of safety and effectiveness of the device; and
- A summary of valid scientific evidence on which the recommendation is based.
If a manufacturer is not aware of information supporting reclassification of its device or is aware of valid scientific evidence that would support leaving the device in Class III, the manufacturer must submit the following information:
- Indications for use – a general description of the disease or condition to be diagnosed, treated, cured, mitigated, or prevented;
- Device description, including, among other things, basic scientific concepts that form the basis of the device;
- Other device labeling;
- A summary of risks;
- A description of alternative practices and procedures for diagnosing, treating, preventing, curing, or mitigating the disease or condition for which the device is intended;
- A detailed summary of preclinical and clinical data; and
- Relevant references and their summaries.
Manufacturers have until August 7, 2009 (120 days after April 9, 2009, when the notice appeared in the Federal Register) to submit this above-described safety and efficacy information. For additional details on specific submission criteria and mechanics, please refer to 74 Fed. Reg. 16214 (Apr. 9, 2009).
For more information about the GAO report or the FDA’s request for information, please contact the authors or other members of our Life Sciences team.