5 Signs Your Medical Device Could Become a Target of FDA Scrutiny

Recent CDRH Enforcement Report Provides Useful Clues

FDA medical device

Last month, the FDA issued a Medical Device Enforcement and Quality Report, which provides a summary of FDA annual inspections data and a good explanation of their current approach to regulatory compliance. In providing this data and their commentary, the FDA is telling MedTech companies that they have a big stick (i.e. the number of annual inspections has gone up in the last 10 years), but they are also offering a sweet carrot (i.e. they are taking a “risk-based” enforcement approach) to focus more on Quality rather than simple Compliance. 

In the past decade, there has been a 46% increase in the number of total device inspections by the FDA and a 243% increase in foreign device inspections.

If you read between the lines, this report provides important clues about factors which can land your medical device in FDA’s crosshairs. There is nothing more intimidating than receiving an FDA inspector at your site for an un-announced, for-cause, inspection! Here are 5 warning signs that can elevate your risk level from the FDA’s viewpoint:

1) You are under-reporting adverse events compared to your peer group.

FDA requires manufacturers to report device related serious injuries, deaths and malfunctions under 21 CFR Part 803. Data cited in the report suggests that manufacturers tend to under-report these events in FDA’s view. Over the past decade, FDA identified deficiencies in adverse events reporting at more than 2,000 medical device establishments. When companies were cited for violations during an inspection, their reporting increased 3 times compared to the year prior to the inspection. Clearly, FDA believes that enforcement through inspections is necessary to drive the right level of reporting. 

But what is the right level?

Unfortunately, there is no clear threshold or a magic number to figure this out. It all depends on the general industry-wide reporting level for the type of device and its maturity level. If the FDA suspects your reporting levels are below the industry average, they are likely to look at you more closely. This is not the only factor in their assessment, but it could be a symptom of other underlying problems.  

2) You are taking longer to respond to field failures including voluntary product recalls.

Medical device recall actions are usually taken voluntarily by manufacturers as a preventive measure to reduce the risk of injury. Under 21 CFR Part 806, these are required to be reported to the FDA. If you are taking longer to respond to field issues either by correcting them timely in the field or issuing a recall, this is another signal to the FDA that there might be deeper underlying quality issues. 

FDA cites data in the report that companies with Part 806 reporting issues reported 20% more voluntary recalls in the year following the inspection. In addition, they were 8 times more likely to report a recall following inspection than the industry average. By focusing on this issue, FDA is claims there was a 50% increase in the number of annual recalls since 2009. 

3. Your devices are malfunctioning more frequently and/or you are having recurring failures.

Malfunctions are device failures compared to specifications. Device failures do not always lead to serious injury, but some of them may have a higher risk than others. These could be software failures, alarms, broken components, battery failures, sparks, fires, or shocks. A single event may not cause injury, but repeated failures can create an ongoing safety issue.

When there is an increase in these failures and the trend continues, or the same type of failure happens repeatedly, there is usually an underlying deeper problem. FDA is more likely to focus on devices with such track record and take action, as in case of the infusion pumps cited in the report. 

4. You are slow to respond to FDA observations and/or your responses are not satisfactory.

FDA expects timely and thorough corrective action to issues identified during inspections. Typically, they will issue a warning letter if they are not satisfied with the response and they don’t believe the corrective actions taken are effective. The number of warning letters peaked in 2012 when 189 such letters were issued representing a more than 7-fold increase compared to 2007.

Lately they have taken a more interactive approach with companies by providing feedback on corrective action plans and monitoring progress along the way.

This is like getting a “second chance” from the FDA!

The FDA has realized that warning letters are not always effective in resolving issues and improving patient safety. Working collaboratively with the violative company seems to be a new approach. As a result, the number of warning letters issued has declined, yet nearly 20% of the companies remain non-compliant on follow-up inspections. 

Expect more scrutiny from the FDA if you fall in this category. Best course of action is to take timely and effective corrective action. 

5. You do not have a culture of quality focused on patient safety and organizational excellence.

Finally, the report cites recent steps the FDA has taken to promote a culture of quality and moving beyond just compliance and enforcement. The hidden message is that the FDA is going to keep an eye on how you conduct business and whether you have integrated patient safety in your strategic business objectives. There is a new expectation on Management Responsibility!

In 2018, the Center for Devices and Radiological Health (CDRH) launched a voluntary Case for Quality (CfQ) pilot program. Although still a pilot program, FDA is considering expanding this into a more formal program in 2019 to complement their traditional oversight activities. This is a carrot-and-stick approach; the idea being that companies who can demonstrate a high level of quality and organizational excellence will lower their burden of FDA inspections. Consider the following statement in the FDA announcement on this pilot program:

“By participating in the voluntary CfQ Pilot Program, FDA intends to forego conducting surveillance inspections. FDA will still conduct “For Cause” inspections where appropriate.”

If you have a culture of quality – not just routine compliance – fear not! Otherwise, there is a high likelihood that FDA will target your organization more scrutiny under their risk-based targeted approach.

The FDA monitors medical device malfunctions, industry compliance trends, and public health concerns to take targeted actions against “high risk” manufacturers.

Keep in mind that the FDA has access to a large amount of data on adverse events, malfunctions, and compliance trends. While the data is not perfect, it is sufficient to raise red flags and provide direction to the FDA to prioritize their enforcement activities.

It is important to monitor your own data, and other publicly available industry data to identify these signals as part of a robust post-market surveillance system.

Don’t become a target for the FDA!


Medical Device Enforcement and Quality Report, 2018

Case for Quality Pilot Program, December 2017

21 CFR Part 803, April 2018

21 CFR Part 806, April 2018