FDA can’t explain record-low medical device recalls

Medical device product recalls were down 14.3% in the federal government’s fiscal year 2021, according to a recent Medical Design & Outsourcing analysis of recall data.

The drop was the biggest since the FDA began publicly reporting the data in 2013, and came as the regulating agency put more emphasis on fighting the COVID-19 pandemic.

We reached out to the agency for more information and connected with FDA press officer Jim McKinney, who said in an email that the FDA could not speculate on the significant reduction in device recalls and recall events, but that the numbers should not be viewed as an indicator of general safety.

The following has been lightly edited for space and clarity.

MDO: We found that medical device recalls were down 14.3% and device recall events were down 18.1% in fiscal 2021. Why was the recall rate down? Was it driven by COVID-19?

McKinney: The number of devices recalled in a year is not an indicator of the safety of marketed devices generally and is not a metric that can be analyzed as a trend. There are many factors that may lead a manufacturer to recall a medical device, including the FDA’s ongoing surveillance of a device and analysis of its performance data, the manufacturer’s ability to remediate issues, and the collaboration between the company and agency to ensure the benefits of the device outweigh risks for patients who used the devices.

The FDA wouldn’t be able to speculate on the reduced number of medical device recalls in fiscal 2021, as the number of recalls varies from year to year.

MDO: What effect has COVID-19 had on recalls since the beginning of the pandemic?

McKinney: The COVID-19 pandemic has not changed the FDA’s critical oversight role to protect and promote public health by ensuring medical devices are safe and effective. However, we have seen some interruptions with notification and reporting to the FDA and implementation of mitigation efforts on behalf of some firms with active recalls. The FDA continues to actively work with these firms to address such recalls and implement mitigation efforts as soon as possible.

MDO: Why is this data important?

McKinney: The FDA is committed to providing transparent data on recalls to help keep the public informed of recalls. The FDA will continue to post notifications of Class I recalls on the FDA’s Medical Device Recalls page and information about all recalls, regardless of class, on the FDA’s Medical Device Recalls database and in the Enforcement Report.

MDO: What does the future look like for the Safer Technologies Program?

McKinney: The FDA believes that the Safer Technologies Program (“STeP”) will help patients have more timely access to these medical devices and device-led combination products by expediting their development, assessment, and review, while preserving the statutory standards for premarket approval, De Novo marketing authorization, and 510(k) clearance.