Product recalls have and will continue to be a constant in the medical device industry. But despite a recent drop in recalls, confusion surrounding 21 CFR 806, Medical Device Corrections and Removals, and what to do once a recall is initiated remains.

In this Q&A with Steven Niedelman, lead quality systems and compliance consultant to King & Spalding’s FDA & Life Sciences practices team (Washington, DC), the former FDA official opens up to MedTech Intelligence about where device manufacturers stand in the world of recalls and the action that needs to be taken once they recall a product.

MedTech Intelligence: What’s the biggest challenge that manufacturers face in the area of recalls and the subsequent action they must take?

Steven Niedelman: Manufacturers wrestle with whether or not a field corrective action is necessary (whether it’s a correction or a removal), whether it’s reportable, as well as accurately assessing the risks associated with the potential corrective action. Industry faces the challenge of balancing severity of risk, frequency and probability of occurrence, and needs to understand that severity of risk trumps the other factors. There have been Class I recalls with simply one event reported that had a catastrophic outcome. When industry considers whether a recall is reportable under Part 806, firms need to take into account information that is available, such as previously classified recalls for the same or similar situation, by accessing the FDA recall database on www.fda.gov to determine how FDA classified that action.

It’s important for industry to understand that they do not classify a recall, the agency classifies the recall. They can just “guesstimate” as to where their recall action may fall. Industry is only responsible for reporting Class I or Class II recalls under Part 806, for those situations that reduce a risk to the patient.

MTI: Are there any misconceptions in this area, and does a lack of transparency between FDA and industry play a role?

Niedelman: For years there’s been a lack of transparency from the agency with regard to how they conduct their health hazard evaluation. Hopefully this congress [Medtech Intelligence conference] will dispel that, and the agency will be transparent and share what they consider to be the important factors.

However, industry needs to do a better job of due diligence when confronted with these situations and obtain as much information and intelligence as possible about similar recalls and situations. This will allow them to more accurately assess their situation to see where they fall with regard to risk associated with a potential field action.

Manufacturers should routinely access the FDA database to see if there are similar recalls and find out what competitors are doing in similar situations. They can’t just randomly say, “our situation is different and therefore we’re a Class III recall and don’t have to report it.” You really need to be objective and do your homework to make the right decision, because there is the potential consequence of the agency disagreeing. With any decision you make, it’s important to document those decisions and maintain that documentation so FDA doesn’t think that it was an off-the-cuff decision not to report.

MTI: Once a company initiates a recall, what’s the single most important action they must take?

Niedelman: If it’s a reportable event under 21 CFR 806, those actions must be reported to FDA within 10 business days of the firm making the decision to take that action. Those 10 days go by quickly, and FDA expects those 806 submissions to be complete. Don’t be late because you’re missing 10% of the information—you can always supplement that. It’s important that you meet the 10-day deadline. FDA has been somewhat aggressive in sending warning letters to those firms that have not reported corrections and removals as they should have been.

MTI: What’s the biggest mistake you see companies make concerning product recalls?

Niedelman: I don’t think it’s a mistake; I think it’s a lack of understanding as to how to calculate frequency and probability. There are many ways of slicing and dicing the data. Many firms will use that data to their best advantage. From an agency perspective, all it takes is one event that could be catastrophic and result in a recall. Firms need to be objective in assessing the information, understanding that severity of risk trumps everything else. Firms need to act appropriately, because the agency will expect them to do so on a regular basis.