What if you submit your 510(k), IDE, or other submission type to FDA only to get an additional information request (AI request)? What do you do for requests that seem overly burdensome? Thanks to a new FDA pilot program known as the Least Burdensome Flag, manufacturers now have a process and methodology they can deploy if and when this scenario arises.

In this episode of the Global Medical Device Podcast host Jon Speer talks to guest Mike Drues, President of Vascular Sciences, about the ways in which manufacturers should approach responding to AI requests via the Least Burdensome Flag program from FDA CDRH.

Some of the highlights of this episode include:

You do have options to push back if you think the FDA’s response or request for more information, data, or testing is overly burdensome or unnecessary.
Understand why the FDA is asking you for additional testing or to collect additional data. The FDA should be able to give you a legitimate reason.
Despite some trite responses, FDA cannot ask you to do whatever it wants. The FDA must give a specific reason, and then you decide whether to accept or fight against it and wave the least burdensome flag.
Informal and formal options include understanding concerns of the agencies and working with review team to come up with a compromise or amicable solution.
Escalating the issue is another option with an email or phone call to move things along and voice your concerns. If a compromise cannot be made, document the final product.
The goal of the Least Burdensome Flag is to quickly address the FDA’s requests that submitters do not believe are least burdensome or held to a different standard than the legally marketed predicate device.
Before throwing the Least Burdensome Flag, you need to meet specific criteria: Try to address concerns with the lead reviewer, limit it to two topic areas, and submit it within 60 calendar days of FDA issuing the request or deficiency letter.
The last resort option is taking the issue to court. Tread cautiously because you can win the battle, but lose the war.

Memorable quotes from Mike Drues:

“Why is FDA asking us to do this additional testing, collect this additional data, whatever? FDA should be able to give you a legitimate reason as to why they’re looking for this information.”

“We should respect the FDA, but at the same time, they should respect us.”

“The goal of the Least Burdensome Flag is to quickly address FDA requests.” “Whatever we do, that needs to be justified. There needs to be a reason for doing it...needs to be justified based on the biology and engineering.”

Links:

Developing and Responding to Deficiencies in Accordance with the Least Burdensome Provisions

FDA/CDRH Webinar - The Least Burdensome Provisions: Concept and Principles

510(k) Submission Process

Investigational Device Exemption (IDE)

ISO 10993 - Biological Evaluation of Medical Devices

Code of Federal Regulations (CFR)

Medical...

When to Throw the Least Burdensome Flag on FDA

Global Medical Device Podcast powered by Greenlight Guru

When to Throw the Least Burdensome Flag on FDA