When to Throw the Least Burdensome Flag on FDA
10/06/21 • 34 min
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
Investigational Device Exemption (IDE)
ISO 10993 - Biological Evaluation of Medical Devices
Code of Federal Regulations (CFR)
Medical Device User Fee Amendments (MDUFA)
The Greenlight Guru True Quality Virtual Summit
MedTech True Quality Stories Podcast
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
Investigational Device Exemption (IDE)
ISO 10993 - Biological Evaluation of Medical Devices
Code of Federal Regulations (CFR)
Medical Device User Fee Amendments (MDUFA)
The Greenlight Guru True Quality Virtual Summit
MedTech True Quality Stories Podcast
Previous Episode
Past, Present, Future State (and World) of Quality in the Medical Device Industry
Quality is a concept that is often overcomplicated in the medical device industry. With complexity comes mistakes, which is why it's so important for manufacturers to simplify!
In this episode of the Global Medical Device Podcast Jon Speer is joined by Mark Alpert, director of quality at Greenlight Guru with thirty years of industry experience in quality, about the past, present, and future global landscape of medical device quality.
Some of the highlights of this episode include:
- Mark and Jon agree that the medical device industry is at a crossroads currently because Europe is a ‘hot mess’ when it comes to quality. Countries with different agendas and requirements led to inconsistencies and interpretations of laws.
- It takes time, often several years, for companies to transition to new or revised regulations and standards.
- Some companies are only beginning to implement, adopt, and change their processes in a way that they understand what risk-based approach means for their management systems.
- Some medical device companies have lost their way when it comes to quality, and many believe the quality profession is partly to blame for being driven by tools, not data.
- Mark describes a do versus don’t do mindset to bring creativity, objectivity, and ability to scale back into the procedure process, such as during audits.
- Do not seek or expect perfection. Do the best you can to move forward and know that there are opportunities for improvements. Demonstrate confidence, compliance, and processes in place that drive improvement.
Memorable quotes from this episode:
“I think today, we’re also at a very interesting crossroads when it comes to quality. There’s a number of different facets.” Jon Speer
“It’s going to take years before companies can really adopt, implement, flow down, and make it inherent in how they do business every day.” Mark Alpert
“Once complexity creeps into the system, you’re just about guaranteeing mistakes will be made that will result in some non-conformances.” Mark Alpert
“A lot of companies, I think their quest is towards compliance.” Jon Speer
Links:
FDA - Quality System Regulation
European Union Medical Device Regulation (EU MDR)
European Union In Vitro Diagnostics Regulation (EU IVDR)
The Greenlight Guru True Quality Virtual Summit
MedTech True Quality Stories Podcast
Next Episode
Quality Insights from a 40+ Year Veteran of the Medical Device Industry
In this episode of the Global Medical Device Podcast, Jon Speer talks to Herschel “Buzz” Peddicord, founder and CEO of InControl Medical, which designs and manufactures patented devices for the control of incontinence.
Listen to Buzz share his valuable insights from spending four decades in the medical device industry, developing products that address and improve quality of life and truly make a difference in patient lives.
Some of the highlights of this episode include:
- Guard Cash: It takes some medical device startups to raise additional rounds of funding and capital, but don’t give up or be ashamed to ask for advice about designing and developing devices to get them to market.
- Anytime you develop a medical device product, you must test, maybe redesign, connect with target customers, and overcome the FDA’s regulatory challenges.
- More than 60 million women experience female urinary incontinence and another 17 million deal with fecal incontinence. Yet, treatments such as medications and surgery aren't effective.
- The two types of female incontinence are stress urinary incontinence due to weak pelvic floor muscles caused by childbirth or high-impact exercise and urge incontinence caused by the overactive detrusor bladder muscle.
- Herschel decided to develop a device that treats both types of incontinence. Attain is a transvaginal device that delivers dual stimulation signals to all muscles involved in causing incontinence.
- No woman has ever died from urinary incontinence, but it dramatically changes their lifestyle. Attain allows women to get away from using pads and diapers to stay dry and avoid leakage.
Memorable quotes from Herschel Peddicord:
“Female urinary incontinence - it is an absolutely huge market. More than 60 million women deal with urinary incontinence and another 17 million deal with fecal incontinence.”
“Incontinence in 90% of the cases is a muscle issue.”
“We have about a 93% success rate at stopping urinary incontinence.”
“As far as we know, no woman has ever died from urinary incontinence, but it dramatically changes their lifestyle.”
Links:
The Greenlight Guru True Quality Virtual Summit
MedTech True Quality Stories Podcast
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