When a novel product (whether it is a medical device, drug, or biologic) seeks FDA approval, it can go to panel. A panel involves a certain group of experts under each FDA center that will meet to approve the PMA and recommend the device market release to the FDA. The panel can heavily influence the release of novel products to the market. Therefore, the individuals on this committee should be carefully chosen. What experience and skill sets do you believe should be requirements to become a member? Would a member with a background in quality control and/or quality assurance provide valuable insight in a FDA advisory panel? Should this type of background be a requirement?
When assembling an expert panel to evaluate a product for FDA endorsement, diversity and a broad range of expertise are paramount to guarantee a comprehensive evaluation of all product facets. This includes its safety, efficacy, manufacturing standards, and overall quality. Key members should encompass medical professionals familiar with the conditions addressed by the product, offering insights into the clinical relevance of trial outcomes, potential adverse effects, and the overarching profile balancing benefits against risks. Additionally, experts well-versed in clinical trial design and interpretation are invaluable for making sense of the data in context. Understanding the statistical significance and ensuring the application of correct methodologies calls for statistical experts, while products with an engineering angle benefit from insights by biomedical engineers or those in related domains. When dealing with pharmaceuticals and biologics, a solid grounding in pharmacology or biotechnology can shed light on long-term effects, interactions, and mechanisms. Quality assurance and control professionals, equipped with an understanding of manufacturing processes and ensuring consistent product quality, add another layer of critical oversight. Their involvement can be instrumental in verifying that the product adheres to good manufacturing practices and that robust systems are in place to address quality-related issues. Ethical experts are also a crucial inclusion, addressing concerns particularly relevant in trials that may pose significant risks or involve vulnerable groups. While having expertise in quality assurance is undeniably beneficial, making it a mandatory requirement might hinder the panel's assembly. It might be more effective to ensure that quality assurance expertise is present when it is particularly relevant to the product in question.
I agree that FDA advisory committees must consist of a variety of experts; yet, I would also add that manufacturing and regulatory considerations are just as vital as clinical and statistical knowledge. Regarding necessary knowledge, members should not only have a strong background in the particular field related to the product (medical devices, drugs, or biologics) but also a thorough awareness of the regulatory environment and manufacturing techniques to guarantee the safety, efficacy, and compliance of the product.
With regard to a background in quality control (QC) and/or quality assurance (QA), I believe this experience would offer insightful panel analysis. Assessing whether the manufacturing process satisfies good manufacturing principles (GMP) and guaranteeing that the product can be consistently produced to the same standard would be tasks for a QA expert. This might stop possible post-market problems such manufacturing flaws causing product recalls.
Though having a QC/QA specialist on the panel will improve the assessment of the safety and quality of a product, I do not think it should be a strict need for every product. Including QC/QA knowledge on panels when assessing products with complicated or innovative production techniques where quality control is a major consideration would be more advantageous.
@fh28 I agree with your perspective on the importance of diversity as well as varied expertise on an FDA expert panel! This is crucial as each member brings a different background to the evaluation, as every side of a product’s safety must be assessed. For instance, including the experts well versed on quality control as well as quality assurance is very valuable since they can guide a team towards successful manufacturing standards and processes. This is overall highly important for ensuring the product is consistent and viable long term. While making a quality assurance expert as a mandatory team member may pose complications in assembling the panel, there is no doubt that their expertise is needed on the team for further success. Along with this, ensuring that the right expertise is present for a given product is important to assess a product’s true safety. For example, a cardiovascular expert should be present when evaluating the safety and efficacy of a heart valve. Given the critical nature of ensuring the right experts for the review of a given product, how can we best determine the priority of choosing experts for an FDA panel?
These are great points. I completely agree that having a diverse panel with a range of expertise is critical for thoroughly evaluating novel products. I think the challenge lies in finding the right balance of skill sets for each specific product being reviewed. For example, products with more complex manufacturing processes would definitely benefit from having QC/QA experts involved to assess long-term viability and consistency. As for determining the priority of experts, it could be helpful if the FDA had a tiered approach, where certain types of expertise like clinical relevance or engineering are always required, and others like QC/QA are included based on the complexity of the product’s design or manufacturing process. This would ensure that the panel is both flexible and comprehensive .
Thank you for your question. It is a very interesting question. I believe that there should be different types of people on the panel.
1. Scientific Expertise: people with relevant scientific expertise in the particular field should be in the panel. It ensures propoer scientific evaluation.
2. Cinicial expertise: clinical experts who use similar products should be in the panel since they can assert how the device will perform in the real world
3.Regulatory experience: they can ensure a tradeoff between innovation as safety.
4. Quality Control and Quality Assurance Experience: They ensure that the product meets rigorous safety, efficacy, and manufacturing standards.
There can be other types of members. However, I mentioned the important person that i believe should be included.
Every user has provided good points on who would be beneficial to be a panelist in a FDA advisory panel. I agree with torikul as they have highlighted generally the most important people that should be included. I would like to add more to each person included. With scientific and clinical expertise, they would be able to understand the science behind the device. In their field or certain research, they would have prior knowledge on what the device is trying to achieve, like what it is intending to treat and the mode of action towards the target audience. They would know more about the human body to understand, for example, if the drug would be able to treat a certain condition, or if a device would be able to help patients with heart conditions or movement issues. This would also include those that have worked with biological tissues and understand the concepts of biocompatibility. These are all scientists or researchers that know the underlying condition, diseases, how materials interact with the body, and the effectiveness to achieve the outcome they want with those devices or drugs. Other types of people that can be included in this section are different types of manufacturers or engineers involved in similar design projects or devices they have worked on. They can provide insight on the device design process and development for that device to provide maximum effectiveness and the desirable outcome throughout the development of their device. In terms of quality assurance and quality control, I think it would be a good idea to include them in the panel because their main responsibilities include ensuring that the product or service meets regulatory requirements, are in compliance, and are within the acceptance criteria. QA/QC can help with risk management of the device and make sure the device is in compliance to stay within the guidelines and standards laid out. They can voice out their concerns if it is non-compliant and that advice can be used to correct their system and product development before any issues arise. I do not, however, think it should be a requirement per say to be a part of the panel.
To answer tm422’s question, I think a questionnaire can potentially help determine the choosing of experts for an FDA panel. It would help to know who has experience in which field of focus. Each panel is different because there are all kinds of medical devices or drugs being developed. Not everyone is well-rounded. If a medical device is centered around the heart, then experts in cardiovascular health should be included in the FDA panel, as well as those that have participated in creating a device revolving around the heart and ensuring the device is in compliance and have met regulatory requirements. I also think that including a consumer representative would be beneficial. They may not have the skills or experience in this type of field, but they would be able to provide the point of view from a consumer or from a patient if they were to use this product and how they think it would help them or not help them.
