I agree with you Jafar, I think it's a good idea to have RA (Regulatory Affairs) in the first meeting as well. Having input from RA could help prevent issues in the future of the project. I personally know of cases where the launch of a new product had to be delayed for years because of regulatory concerns. RA was only consulted at the end of the project and that's when the team discovered regulatory gaps - took over 2 years of additional work to correct (there was nothing wrong with the product, it was all about documentation).

Companies hire FDA consultants before they're in trouble to ensure they set up their quality management systems (QMS) correctly. Organizations most commonly hire an FDA consultant when they're facing FDA action or challenges with a product submission .I think it is important to have a FDA regulatory consultant in the first meeting.

Hello All, 

This thread is a little bit of a surprise to me. I would have thought that the (RA) regulatory associate would be one of the most essential people in the entire group. It seems logical to have a person that could tell you what level of clearance the device will need, if there are others like it that could perhaps allow this one to have 510(k) clearance, and how long the regulatory process could take. In addition, there are regulations in place on the company that the device will be sold to or how it would impact different FDA/CDC rules for the sell to the public. I may be over valuing their role, but from my background in the laboratory, regulations are a huge part of the business and everything we change or think of implementing goes through them as well as admin of the company. Very surprising to hear that some companies rather risk a big fine opposed to having a RA on all parts of the project. 

Before this post, I didn't think to have an FDA Regulatory Consultant involved so early on. While I understand the need for customer sales rep and and sales rep for the first meeting, the need for an FDA Regulatory Consultant feels premature only because this is the initiation point where mainly stakeholders are involved. However after reading through the posts, I do understand the need for FDA Regulatory Consultants at first meeting. It might be important for them to be able to highlight any outstanding issues and obstacles early on in the project before putting in resources and money. Not only will it save resources and money to have regulatory associates early on, but it may save time as well. They bring a unique perspective as they can be able to give you a good idea on where the project is potentially safe or unsafe for the market which is extremely important in the field of medical devices. They can also make sure you are on track within the legislation early on as well as advise on any restraints and requirements. This is a huge advantage as you can also effectively prepare and plan because you are made aware of any possible milestones that might be affected, thus giving you a more approbate timeline. After further research, I can effectively conclude that FDA consultants should be joining meetings early on for projects. 

I think its interesting that the question is about FDA Consultants, because there will certainly be a regulatory affairs division in any medical device company and any projects related to new or existing products will require regulatory sign-off on any design submissions, however I am not very familiar with the use of a paid consultant from the FDA. I wonder when an FDA consultant is brought in vs the internal regulatory team. Is it just as @nikhil-nagarjun said, that they are only brought in when there is a particular challenge in the FDA submission? Or do start-ups and smaller companies typically utilize FDA consultants? Additionally, not all projects at medical device companies involve product directly (for example I am working on test method improvement) so a regulatory partner or FDA consultant is not necessary for project completion.

I agree that a FDA consultant should be included in the first project meeting. However, I believe this should also extend to other international regulatory bodies, specifically any international market the company is seeking to enter. It does not have to be every single regulatory body as certain countries/groups of countries follow the same guidelines as another. This is important as some countries are stricter in their regulations regarding medical devices. To avoid any future issues, the company should include a variety of regulatory consultants in the first meeting. While interning at a biopharmaceutical company, I worked with one of their commercially available biologic’s manufacturing documentation and regulatory filings. There I supported the harmonization of the various regulatory filings to ensure the filings are in compliance with the 3 major markets the biologic is in. Although this experience is within the context of the biologics division of regulatory affairs, it still demonstrated to me the importance of maintaining compliance with multiple regulations from different countries. If the product is manufactured according to acceptable ranges not approved by an agency, the product’s continued existence in the market is in jeopardy. Overall, I agree with the suggestion that regulatory consultants should be in the first project meeting to ensure an easier approval process with the regulatory bodies.

Hello,

In medical device projects, the involvement of an FDA Regulatory Consultant can be considered essential, particularly in the early stages of project initiation. As Professor Simon highlighted in the lecture, the inclusion of customer service and sales representatives is vital for gaining insights into market needs and customer expectations. Similarly, the presence of an FDA consultant holds significant value, playing an imperative role in regulating medical devices and ensuring their safety and efficacy. Having an FDA consultant in the initial project meeting is advantageous for several reasons. Firstly, an FDA consultant can provide crucial guidance on navigating the regulatory environment, helping project teams understand the compliance requirements and potential pitfalls. They can assist in determining the appropriate regulatory pathway for the device, whether it falls under 510(k) clearance, premarket approval (PMA), or other categories, and guide the project in meeting the necessary documentation and testing standards. Secondly, early engagement with an FDA consultant can streamline the product development process. By addressing regulatory considerations, project teams can avoid costly delays and setbacks later in the project. This proactive approach can lead to a more efficient development timeline and a higher likelihood of successful FDA submissions.

Hi Jafar,

I absolutely agree that having FDA Regulatory Consultant in medical device projects is essential. Medical devices are subject to strict regulations due to their requirements regarding patient health and safety. This is especially important for ensuring that devices remain necessary and effective as well. An FDA consultant can help the team navigate the vast regulatory requirements in order to approve the product for market use. Understanding and focusing on the FDA requirements from the start ensures that the product develops in a way that is compliant with FDA standards.

Without the guidance of an FDA consultant, teams run the risk of developing unsafe products, which is not only unethical but also highly unproductive and illegal. Products may even be ineffective, which wastes time and resources for both medical device companies and their customers. Therefore, it is important to consult with the FDA and remain in compliance because this allows customers to use safe products as well as trust the products they are using. 

That being said, most of us agree that a FDA consultation is necessary, but how often should this consultation happen in the process of developing a medical device? Is it sufficient enough to consult at only key milestones?