Frequently Asked (Regulatory) Questions

By Bob Marshall, Chief Editor, Med Device Online

The pivot from 25 years as a medical device practitioner to the chief editor’s chair at Med Device Online has been fun. But the change has not been without its challenges. I would MUCH rather wrestle with the most ornery FDA investigator than deal with writer’s block when I need to be creating new content every day.

Seriously, though, the biggest struggle has been the feeling of stepping out of the trenches of medical device development and manufacturing. When I first made the change, I feared I would become disconnected from the daily hands-on opportunities to help create solutions that would eventually result in a better quality of life for people that use medical devices. That is why most medical device professionals come to work each day – to make a difference!

Fortunately, I realize now that I can still make a difference, but in other ways. I get to meet and talk with medical device professionals and leaders every week. They share their stories of success and their challenges. Occasionally, they ask for opinions about situations they are facing. I recently gave a lecture at the University of Pittsburgh on regulatory affairs, and the participants had some great questions about the regulatory aspects of their projects. These experiences have compelled me to write about some of the questions frequently posed to me over the years.

Is A Pre-submission A Good Idea Or A Bad Idea?

This is probably the most frequently asked question by start-up companies. They hear lots of things – both good and bad – about the preSub or Q-Sub process. I have personally heard former FDA personnel – who have moved on to consulting roles – speak about pre-submissions, and they seem to have a negative opinion of the value of the process.

Many of these ex-FDA staffers worked for the agency when pre-submissions were known as a pre-IDEs, and were used primarily for dialogue with the FDA about investigational device exemptions prior to a clinical trial. Since that time, pre-IDEs came to be used for other types of dialogue and, in the spirit of transparency and collaboration, became feedback on medical device submissions in final guidance from the agency, drafted in 2012 and finalized in 2014 (and then updated in 2017).

My own experience with the pre-submission process has been very good; I have seen two very positive outcomes. First, preparing the preSub package requires a company to gather information and describe the device and its use for the FDA. This often reveals gaps in understanding that can be remedied earlier in the development process.

The second advantage of putting the preSub together is the careful formulation of questions for the FDA. Remember, we don’t ask open-ended questions like, “What kind of clinical trial would the FDA like to see for this type of product.” Rather, do the work of crafting a draft clinical plan to include in the preSub package, and ask the FDA if they agree with the plan. The more we can “think like the regulators,” the better chance we have of an expedient clearance or approval.

Can I Get My Medical Device On The Market Sooner With A Europe-first Strategy?

I have heard this question numerous times over the past two decades. In my mind, there is no question the correct answer used to be “yes” — as long as the company had the right partnerships, physical presence, and logistical arrangements to capitalize on the European market once the CE Mark could be applied. Clinical requirements in the EU seemed to be more reasonable than in the U.S., and the Medical Device Directive set a lower, more collaborative bar than FDA requirements.

However, if we look at this question today, much has changed, or is in the process of changing. The European Commission adopted its updated Medical Device Regulations last year, which take full effect in 2020, following a three-year transition period; the EU’s In Vitro Diagnostics Regulations (IVDR) will be fully implemented in 2022. In adopting the new regulatory framework the Commission wrote, “The Commission welcomes the adoption of its proposal for 2 Regulations on medical devices which establish a modernised and more robust EU legislative framework to ensure better protection of public health and patient safety.”

At the same time, here in the U.S., the FDA is talking more about collaboration and focusing on improving its performance relevant to a number of goals outlined in 2017’s Medical Device and User Fee Amendments (MDUFA) IV. According to the Center for Devices and Radiological Health (CDRH) at the FDA, “Industry agrees to pay user fees for specific medical device submissions and other efforts (while) CDRH agrees to increase resources and make reviews more timely, predictable, and transparent.”

We will have to monitor the roll-out of the EU MDR, but I expect any previous benefit of a Europe-first strategy will be lost.

How Much “Paperwork” Will I Need To Get My Device On The Market?

I find this question one of the most difficult to deal with – not because the answer is complex, but because the nature of the question indicates a basic lack of understanding. The medical device development process does require documented procedures for development, manufacturing, and during commercial operations. In many cases, a submission to the FDA for clearance/approval also is required.

But it’s not about the volume of the “paperwork”! It is about developing a mindset and culture within the organization that instinctively does the right things in the most efficient manner to get the device on the market.

If the proposed device is not GMP exempt, the company will need a full quality management system of some 20+ procedures and associated forms. This is not a binder on the shelf. Procedures are created and implemented, training is provided, and both are improved and kept up-to-date. Additionally, if the proposed device is not 510(k) exempt, a submission will be required to get the device on the market. This should be done with great care.

We know from guidance documents what the contents of such a submission should include; just shoveling information into the package is always a bad idea. Start with a clean outline of the content, and include supporting descriptions and reports in the most clear and concise manner. Remember, the FDA has to review every page you provide – make sure each one counts.

We are 510(k) And GMP Exempt; Do We Need To Register With The FDA?

To register or not to register, is that even a question?!! I will admit this one is a bit scary, but there is no such thing as a bad question. I have worked with a few small companies over the years whose devices were Class 1, 510(k) exempt, and GMP/QSR exempt.

Unfortunately, this situation often leads these companies to think they do not need any further interaction with the FDA. That’s bad thinking, if the product meets the FDA’s definition of a medical device. Even with these lowest-risk, least-regulated medical devices, a few things still are required: The company MUST register with the FDA, list its device(s), and pay the annual registration fee. In addition, even with the exemption from GMP/QSR requirements, the device manufacturer must create and document a system for complaint handling and document a method for record retention.

For those of you who develop or manufacture medical devices, what questions do you have? For those of you who work in regulatory or quality, what questions have you heard frequently? Feel free to share in the Comments below.