Help! Survey Says Outside Help is Beneficial in FDA Remediation Processes

Underwriters Laboratories (UL LLC), a Northbrook, Ill.-based safety science company, recently completed a survey of medical device companies and how they respond to U.S. Food and Drug Administration (FDA) enforcement actions such as Form 483s and warning letters.

According to the report, in 2012, the FDA’s Center for Devices and Radiological Health (CDRH) issued more than 4,000 483s to medical device companies, and 210 warning letters. In addition, the CDRH reported that companies recalled 2,475 products in 2012. While all indications point to a slight decline in these numbers in 2013, the 2012 data suggests that many life science companies must prepare for, and respond to, more FDA facility inspections.

Survey respondents were mainly quality, regulatory or compliance executives. Thirty-four percent of the medical device companies had 1,000 employees or more; seventy-seven percent made Class I or II devices; and 67 percent were in the cardiovascular, electromedical, and implantable device sectors.

A main focus of the survey was to evaluate how much medical device companies use third party consultants to aid in remediation with the FDA post-enforcement action; whether companies were satisfied with using third parties; and what they are looking for in third parties.

In the United States, FDA inspections are unscheduled, which, as UL’s Health Sciences division Marketing Manager Tara Kambeitz points out, is a novel experience for medical device manufacturers based abroad.

“Most of the other regulatory agencies around the world have an annual audit schedule,” Kambeitz told Medical Product Outsourcing. “They come in every year and people know what to expect. They know what an ISO 13485 audit is going to be like and what to expect from their auditors. They know what to expect from their notified body. Having the FDA come in on relatively short notice and not knowing what to expect is very different for our customers outside the United States  It is a different audit mentality.”

Seventy-five percent of survey respondents indicated they had been inspected by the FDA, and out of those, 30 percent said the inspection happened in the past two years. Consistent with the FDA’s own statistics about the nature of the findings, both CAPA (corrective action/preventative action) and complaint management topics were cited most often by respondents. The survey allowed for respondents to enter a category of FDA concern that was not represented, and 10 respondents wrote in “design controls.”

“This is not surprising, as FDA has repeatedly told industry that design is the beginning of the device product lifecycle, and when the product reaches the market, CAPA serves as the feedback loop that improves risk assessments and drives design improvement,” the report stated.

Companies such as UL are learning that offering certification services is becoming less of a value-add service and more of an expected service.

“Companies are having trouble getting regulatory approval in markets around the world,” said Kambeitz. “Of course, FDA has a reputation as one of the toughest regulatory bodies to get approval from, especially for our customers that are based in other countries.”

The majority of respondents to the survey were small, under 1,000 employees. These, said Kambeitz, are the companies that face the most challenges.

“FDA enforcement actions that typically make the news are the findings at large companies with stockholders and products that are very public,” Kambeitz explained. “Smaller companies that don’t have the same level of resources face a bigger challenge. It’s all the more important for them to reach beyond their internal resources, to make sure they don’t fall down a path of destruction. Once you move beyond the warning letter, FDA can require the use of third parties to verify compliance with FDA QSR rather than you resolving the issue using your own resources. So it can get quite expensive and damaging to a company’s reputation.”

And as anyone with products on the market knows, reputation is everything. This is where companies can benefit from the experience of third parties such as UL, as they can lend their own name recognition to a company that the FDA may not have much prior experience with. Customers have said as much to Kambeitz, who noted that the more experience a company has with remediation, the more likely they are to find success with the FDA. In fact, one survey respondent made sure to stress that “reputation with FDA and proven experience” was the most significant qualification desired when hiring a third party consultant.

Survey respondents bolstered the idea that hiring an outside consultant was more beneficial than relying on internal resources:

“It helped to bring in an ‘outside’ perspective to get better buy-in from upper management,” said one respondent.

Another noted that while it was beneficial to get outside help at some locations and in some divisions, it was found unnecessary with others.

The most popular reason respondents said they chose a third party was that they “needed quick resolution and dedicated resources.” Indeed, the response time for Form 483s is just 15 days, so speed is a necessity.

Disorganization and sub-par expertise is the death knoll for third party consultancies, according to survey respondents, which is why, Kambeitz noted, consultancies need to have a deep reach into the community of experts. Former FDA inspectors are ideal resources, as they have the very specific skill set and experience needed to help companies understand the FDA’s expectations and processes.

But as the old adage says, if you want to feed a man for more than just a day, teach him to fish. Training a company’s internal staff using the same training course used by FDA inspectors themselves—a service UL offers—is an ideal way to prepare company staff for inspections both in the short and long term.