On Thursday, December 15, 2011, Senators Chuck Grassley (R-Iowa), Richard Blumenthal (D-Conn.), and Herb Kohl (D-Wis.) introduced the “Medical Device Patient Safety Act.” This bill contains two distinct proposals: (1) to give FDA the authority to track and trend device recalls, and (2) to allow FDA to grant conditional clearances for devices that will be subject to post-market requirements. A summary of the bill is available here.
Recall Tracking. While FDA currently has the authority to track and trend recalls, using information submitted to it under section 519 of the Federal Food, Drug, and Cosmetic Act (“FDCA”) and 21 C.F.R. Part 806, it is not required to do so. This bill would require FDA to routinely assess (1) any information provided to FDA in response to a recall request from FDA under section 518(e) of FDCA, and (2) information required to be reported to FDA under section 519 of the FDCA regarding a correction or removal. Because a Class III recall would not meet the standard for an FDA-requested recall (“reasonable probability that [the device] . . . would cause serious, adverse health consequences or death”) and information regarding Class III recalls is generally not required to be reported to FDA, the language of the bill essentially means that the program would require FDA to track and trend all Class I and Class II recalls, whether the recalls were requested by FDA or initiated by the manufacturer. The bill instructs FDA to “use the assessment of information” gathered by the program to “proactively identify strategies for mitigating health risks presented by defective or unsafe devices.” Importantly, the bill does not give FDA any authority to remove from the market devices cleared through the 510(k) program that FDA determines are “defective or unsafe” based on its tracking and trending of recalls.
The bill also requires FDA to “develop explicit criteria” for assessing whether a company subject to a recall or required to report information regarding a correction or removal “has performed an effective correction or removal action.” This appears to give FDA very broad latitude in determining what constitutes an “effective” recall, and is not clear whether this language implies a “one size fits all” solution for determining recall effectiveness. Certainly what may be effective for one type of device may not be effective for another, and there may in fact be differences among devices of the same type. If Congress enacts this language, hopefully FDA will consult with industry before developing “explicit criteria” that may be impossible to achieve, or that may not be effective for particular devices in unique circumstances.
Conditional Clearance. The bill proposes amending the FDCA to insert section 510A, Conditional Clearance of Certain Medical Devices. This would allow FDA to grant conditional clearance for devices cleared through the 510(k) process. While summaries of the bill indicate that conditional clearances are intended to apply to devices that may have safety concerns, the plain language of the bill does not state when conditional clearance would be appropriate, or any factors FDA must consider in determining whether to grant a conditional, rather than traditional, clearance.
The conditional clearance proposals appear to largely mirror the authority FDA currently has to require conditions of approval for PMA devices. For example, the bill would give FDA the authority to use the post-market information to evaluate “the safety, effectiveness, and reliability of the device for its intended use.”
A grant of conditional clearance would also greatly expand FDA’s authority over the labeling and advertising of a 510(k) device. Currently, FDA has the authority to review the draft labeling of a device undergoing 510(k) review to determine the proposed intended use, and only has authority over the advertising of restricted devices. Although FDA may condition 510(k) clearances on modifications to the draft language, it does not have specific authority to require certain language in the labeling or advertising of a 510(k) device. Under the proposed conditional clearance language, however, FDA will have the authority to require conditionally cleared devices to contain “a prominent display in the labeling of the device and in the advertising of warnings, hazards, or precautions important for the device’s safe and effective use, including patient information such as information provided to the patient on alternative modes of therapy and on risks and benefits associated with the use of the device.” Thus, the bill appears to give FDA authority over conditionally cleared devices similar to the authority it has over PMA devices. Because the bill does not specify the types of devices that may be appropriate for conditional clearance, FDA could seek to use conditional clearance as a means of exercising expanded authority over the labeling and advertising of 510(k)-cleared devices.
Finally, the bill states that FDA may rescind the conditional clearance of a device if FDA determines that the conditions of clearance have not been met. This again mirrors FDA’s authority to rescind a conditional PMA approval.
Industry has been encouraging FDA to increase use of its post-marketing authorities for 510(k) devices, with an understanding that this could reduce the burden of pre-market data. FDA already has sufficient authorities to require manufacturers to conduct post-market studies for devices cleared through the 510(k) process, and it therefore seems unnecessary to provide additional authorities via a conditional clearance process. Most critically, the bill does not limit when FDA may conditionally clear a device, thus leaving open the possibility that conditions of approval will become a regular part of 510(k) clearances, as they are for PMAs. Conditions of approval should be specifically reserved for those devices for which FDA has raised a legitimate safety concern, supported by scientific evidence. It should not become the new standard for clearing devices.