James R. Ravitz and James H. Hartten04.05.06
FDA Focuses on Improving Medical Device Safety
James R. Ravitz, James H. Hartten
Arent Fox PLLC
James R. Ravitz James H. Hartten |
On January 20, the FDA announced its intent to implement a major new initiative to modernize the way the agency monitors the safety of medical devices after they are introduced into the marketplace. The new program, which the FDA refers to as its “Postmarket Transformation Initiative,” is intended to improve device safety by allowing the agency to identify, analyze and act on problems more quickly, including alerting the public sooner when a potential device safety issue arises. Further, on February 8-9, the FDA and AdvaMed (the Advanced Medical Technology Association) held a public workshop aimed at improving the oversight of medical devices once products reach the market.
These device safety measures come on the heels of the agency’s imposition of labeling, device validation and reporting requirements on manufacturers of reprocessed single use devices. Moreover, as details of the FDA’s proposals for monitoring post-market device safety begin to materialize, it appears that the agency expects the device industry to do much of the “heavy lifting” involved in implementing whatever program takes effect.
The industry has a vested interest in following the FDA’s efforts to implement a new post-market safety program to ensure the program does not overburden medical device manufacturers with new regulatory requirements that ultimately may not improve the overall safety of medical devices in the marketplace.
Initiative Details
The FDA’s decision to develop and implement the new safety program was born from a recent review of its current post-market safety programs, including those related to device recalls, MDR reporting and MedSun. On the basis of its review, the FDA drafted a report on medical device safety that, in part, identified weaknesses in the agency’s current device safety web that the FDA intends to address through the Postmarket Transformation Initiative.
The program is being administered by the FDA’s “Postmarket Transformation Leadership Team” from the Center for Devices and Radiological Health (CDRH). This group consists of senior level FDA management as well as outside consultants who are experienced in device safety and medical product regulation. The Leadership Team is in the process of evaluating the FDA’s recent report on device safety and developing recommendations on how to improve safety. The Leadership Team hopes to draft a set of recommendations on how to improve device safety by May or June.
According to the FDA, the agency initially intends to focus on the following areas in its implementation of the medical device safety initiative:
• Developing a more effective electronic reporting system for device related adverse events
• Harmonizing medical device nomenclature to improve the identification of medical devices and device safety issues on a global basis
• Improving the identification of device information in patient records
• Facilitating better internal (FDA-wide) collaboration on postmarket safety issues
• Working with the device industry and professional organizations to find ways to improve the safety of medical devices
However, the FDA’s limited budget may restrict any final implementation of its device safety measures. Congress has not authorized any new funding to implement the program, and it is unclear if the FDA will have the resources available to effectively administer a new post-market device safety program.
Proposal for Expanded Reporting
On February 8-9, as a follow-up to announcing its Postmarket Transformation Initiative, the FDA held the first of several collaborative meetings with the public and industry on device safety in the form of a public workshop, “Connecting the Dots of FDA’s Postmarket Safety Activities,” that included participation by AdvaMed. The workshop included discussion on a wide variety of device issues, such as the FDA's recent analysis of post-market safety trends; the device industry's perspective on post-market issues and regulations; new perspectives on product recalls, removals, and corrections; and better collaboration with the industry.
Importantly, the FDA presented draft recommendations on how annual reports for devices subject to pre-market approval (PMA) could be used for monitoring post-market device safety. Currently, annual reports are used to account for device, labeling and manufacturing modifications. This could significantly change, however.
Specifically, the FDA proposed that the content of annual reports be expanded to include device safety information. Under this proposal, companies filing annual reports would be required to include information regarding device changes, adverse events and product complaints. With respect to adverse events, the FDA proposed that companies include a detailed analysis of trends and patterns in device malfunctions or patient inquiries. Such analysis, the agency hopes, would compel companies to examine adverse events more closely and allow companies to arrive at their own conclusions on whether corrective action is necessary. If implemented, this would be a dramatic shift in the current annual reporting requirements.
As a practical matter, expanding the scope of annual reports may prove to be burdensome for both the government and industry—and, ultimately, may not affect the change that the FDA is seeking. From an industry standpoint, amending the annual reporting requirements will tax company resources.
A great deal more data and analysis would need to be included in the report and would require companies to implement new internal procedures for collecting the data that the FDA is seeking. From a government standpoint, reviewing detailed annual reports will require additional staffing and, of course, funding to ensure that the reports are reviewed in a timely fashion. The FDA has acknowledged that even under the current annual reporting system, it has difficulty reviewing annual reports in a timely manner. Further, the proposal does not account for 510(k) cleared or devices merely subject to general controls, which comprise the majority of devices sold.
Conclusion
The FDA continues to grapple with methods for patching the holes in its post-market device safety network. While a number of initiatives are being proposed, a number of questions also must be addressed. Can the FDA effectively implement a post-market program without providing new funding to CDRH to upgrade the timely surveillance of data and information emanating from the marketplace? If the FDA ultimately expands the annual reporting requirements, will the data be used in a meaningful way? Further, will CDRH react to the lack of funding for the safety initiative by imposing regulatory demands or additional user fees on the industry that have not necessarily been proven to affect device safety and protect patients?
It is at this early stage of device safety rulemaking where companies should monitor the various regulatory proposals and carefully consider how their own safety programs will be affected by the shifting tides. As a consequence, members of the device industry must remain vigilant in working with the FDA to ensure that any final medical device safety initiative is fair, effective and implemented correctly.