How Your Medtech Company Can Build Trust With FDA Investigators – And The Agency At Large
A Compliance 360° Q&A
Device makers that build bridges with US FDA investigators will have an easier go of things during facility inspections, says Ricki Chase, a former FDA investigations branch director. By doing this, firms can extend that trust to the agency as a whole. Check out our full Q&A with Chase here.
Medical device manufacturers that build bridges with US Food and Drug Administration investigators will have an easier go of things during facility inspections, an ex-agency official says. By doing this, firms can extend that trust to the agency as a whole.
“Professionalism is critical.” – Ricki Chase
“Building trust with the investigator, and therefore the agency, is an integral part of successfully navigating inspections, and if necessary, response to an official action,” said Ricki Chase, compliance practice director for Lachman Consultant Services and a former FDA investigations branch director.
“The investigator is the person you will most frequently interact with, and as ORA likes to say, the eyes and the ears of the agency. This is one of the most critical relationships you will build,” she told Medtech Insight.
ORA is the FDA’s Office of Regulatory Affairs, which handles all the agency’s field activities.
Read our full Q&A with Chase below.
We conducted a routine quality system inspection, but we didn’t see the complaint in the firm's record, or in their MDR filings. And we asked several times if they were aware of the matter, and they denied knowledge for three straight days. On the fourth day, we were presented with a file containing the details of the complaint and its investigation. We were told that it was found in the desk drawer of a member of senior leadership at the firm.
Needless to say, it was difficult to trust the personnel or the documents moving forward.
You should read and train on the FDA’s Investigations Operations Manual, and understand how inspections are conducted and what to expect. This will help you plan and prepare accordingly. Not knowing who to call when the investigator arrives, demanding they sign confidentiality agreements or no-photo agreements, or stalling them on arrival, all diminish trust and send the message that you do not respect that there is a job to be done.
And professionalism is critical. You would be horrified to refer to a member of your leadership by the wrong name. So, learn the investigator's name and how they would like to be addressed. Most investigators are very comfortable with the use of their first name. However, public health service officers may want you to use their title. I was once referred to by the wrong name every day for a 10-day inspection, and it wasn’t until I signed the FDA-483 [inspectional observation form] did they realize they had called me by the wrong name the entire time. It was not good.
Your professionalism goes beyond knowing the investigator's name, however. It also goes to the attitude and posture presented during the inspection. Investigators who are met with aggressive, confrontational, or even weepy management begin not to trust your intent. Aggressive and confrontational individuals are perceived to be hiding something, and weepy individuals are perceived to be creating a distraction from the process.
There have been times when the most responsible individual at the facility has refused to present themselves to receive those documents. FDA investigators are trained that it is their responsibility to issue to this individual. Failure of this individual to produce themselves is seen as leadership shirking its responsibility. So, always strive to present the right person for the job.
Making your knowledgeable staff available demonstrates that personnel at all levels of the organization can communicate their understanding of their role. It also demonstrates that management has nothing to fear from a frontline employee relaying their day-to-day activities.
And keep your promises. Whether you say you will do something during the inspection, during the close-out meeting, or in writing, keep your promises. If you promise a timeframe, do everything possible to meet that timeframe. And if you will not, let the agency or investigator know this before the deadline arrives.
It may feel or seem cliché, but the agency really does view the promotion and protection of public health as a team effort between government, industry and academia. Seek to work together, provide explanation, ask questions, keep promises, and speak to each other with respect for the role that each play. A comfortable conversation builds trust in your knowledge, and in your intent.