Medical Device Enforcement and Quality Report

December 3, 2018By Anne K. Walsh & Adrienne R. Lenz, Senior Medical Device Regulation Expert

In light of recent criticism of FDA’s oversight of medical devices, it is curious why FDA did not release a report touting the success of its enforcement activities with the same fanfare as its report on its plan to modernize the 510(k) program, which we reported on here. The Medical Device Enforcement and Quality Report (Report), available here, claims FDA’s increased inspections have led to improved compliance by industry. The Report provides five conclusions:

  1. The FDA has increased its oversight through additional device inspections.
  2. The FDA has taken a targeted, risk-based enforcement approach to address specific device areas of concern.
  3. The FDA’s focus on violative products and adverse event reporting during inspections has led to an increase in voluntary recalls and adverse event reporting.
  4. Most firms have corrected violations on follow-up inspection.
  5. The FDA has taken steps to promote device quality, not just compliance with regulations.

In the first section of the Report, FDA notes that since 2007 there has been a “46% increase in the annual number of device inspections” (from ~2000 inspections in 2007 to 2952 in 2017) and a “243% increase in the annual number of foreign device inspections” during the same time period. Report at 2. FDA also gives itself credit for implementing the Medical Device Single Audit Program (MDSAP), which permits FDA to accept regulatory audits by other jurisdictions. It is unclear how this increased number of inspections corresponds to the total number of registered medical device facilities (i.e., whether FDA is inspecting a greater percentage of registered medical device facilities now than in 2007).

The second section of the Report describes how FDA uses a targeted, risk-based enforcement approach to address issues that FDA identifies through reported malfunctions, industry compliance trends and public health concerns. The report provides three case studies as examples of success stories: infusion pumps, automated external defibrillators (AEDs) and radiation therapy devices. Each case study identifies the numbers of inspections conducted, facilities inspected, and warning letters issued, and highlights improvements in reductions of recalls and adverse events as a result of these actions.

Next, the Report notes that FDA has focused on reporting of recalls as required in 21 C.F.R. Part 806 and reporting of adverse events as required in 21 C.F.R. Part 803 during inspections. FDA concludes that firms are more likely to report recalls and adverse events after receiving inspectional findings. This seems to be an obvious result. The open question remains whether the public is better served by compliance with reporting obligations.

Similarly, the fourth section reports that firms tend to have corrected violations on follow-up inspections. FDA notes that through their increased number of inspections and focus on higher risk device types, “the annual number of Official Action Indicated inspections has increased 59%” and that the number of Warning Letters also increased between 2008 and 2012. Id. at 7. Interestingly, despite seeing positive outcomes from their increased scrutiny, the report indicates that more recently there has been a decrease in the number of Warning Letters issued as FDA is taking a more interactive approach with violative firms. Indeed, FDA issued just 32 Warning Letters to device companies in FY2018; compared to 213 letters issued at the peak in FY2012.

The final section provides an overview of the Case for Quality initiative launched in 2011 to elevate industry’s focus from “baseline regulatory compliance to sustained practices that advance medical device quality and safety to achieve better patient outcomes.” Id. at 8. According to FDA, reports coming out of the pilot program, specifically related to use of a voluntary quality maturity appraisal model, suggest positive outcomes.

Overall, the Report’s message is that enforcement actions are robust and effective. It is unclear whether FDA intends to update this report annually, using other case studies to support effectiveness of its efforts. Firms should continue to be diligent in ensuring compliance and inspection readiness and may also benefit by looking beyond regulatory compliance to further promote device quality.

Categories: Medical Devices