I agree that those devices may need to be regulated by all three sub-agencies. If the design contains any drug or biologic components, the other agencies might come after us if we don't get those components approved by them. I think it would be less of a hurdle to misclassify your device as highly risky, than misclassify as low-risk, hurt lives, and risk going to jail. Pre-PMA and Pre-IDE meetings take place for these discussions. Its better to have conversations with Regulatory and FDA sooner than later so that the gray areas can be resolved before filing for the wrong sub-agency or class categories. These mistakes can cost the company a lot of time, and be a very expensive mistake to submit the wrong document to the wrong agency.

I agree that sometimes it is difficult to classify a medical device, especially if it is a combination product. Having a combination product brings in the additional challenge of determining the primary mode of action to see if the CDRH, CDER, or CBER will be involved. To prevent misclassification, the company can look at similar combination products that perform in a similar way and raise similar safety and efficacy questions. Misclassifying can waste time, money, and resources which can be very detrimental especially if the product is highly valuable or if it is a starup company with few resources. To prevent this, the FDA has a Request for Designation process which can help a company know what the lead center will be. This process does take 60 days which could delay approving a product, but it is better to do this than not be prepared for the lead center's approval process. As for the classification of medical devices within the CDRH, companies can either informally request the CDRH for guidance or submit a 513(g). The FDA has a process called the 513(g) where companies can request a formal classification and recieve information on the product's specific regulatory requirements or exemptions.

It is better to be proactive and ensure you are classifying your product right, especially since the FDA has measures for this. Sending in a request for the wrong classifcation can lead to fines, wasted time and money, and a diminished reputation of the company.

Hurdles may not be the right term to use when accidently classifying a device as a Class III instead of a Class II. From a project management prospective, misclassifying a medical device within the wrong section can be detrimental. The approval process for a Class III device is significantly more expensive and more time consuming. From a safety perspective, a misclassification theoretically can ensure the device is proven to be safer than it has to be. From a practical perspective as others have mentioned, going through the process of allocating resources for costly clinical trial designs and post-approval studies when a 510K would have sufficed is not good for project morale. It would be a solid assumption to make that for more traditional devices, early interactions with regulatory agencies and advisors significantly reduce the likelihood of misclassifications. For more modern devices, which begin to incorporate AI or other functions, the "grey area" does become more apparent. The question would then relate back to the idea of whether regulatory agencies are too slow to update their regulations. In the modern and future generation of medical devices, misclassifications may become much more common then they already are.

This topic raises an important question about the flexibility of medical device classification, particularly in ambiguous cases. In reality, the classification process inherently involves many grey areas, and real-world cases tend to be even more complex.

Since regulatory decisions involve close collaboration with FDA agents, how a device is classified can sometimes depend on how the submission is structured. The way a company presents its device in regulatory filings plays a crucial role in determining its classification. As mentioned in the lecture, "It's all about what you write in the document."

This raises an interesting point: Could a true Class III device be described in a way that makes it more justifiable as a Class II? If so, would companies intentionally take this approach to avoid the stricter requirements and higher costs associated with Class III regulations? These are key considerations in the regulatory landscape and highlight the strategic role of regulatory affairs in medical device approval.

Filing for FDA approval of a misclassified device can cause major hinderances to the entire process, whether the company filed a class II device as class III or the other way around. The time from submitting an application for approval to hearing back from the FDA can be significant, so it best to avoid mistakes as much as possible in order to shorten this communication. If a company were to file a device as Class III and be told by the FDA that it is actually Class II, then they would have wasted time and resources on over-testing in order to meet the tight demands of a Class III device. Although over-testing a device is not the worst thing that could happen, it could be a costly mistake that delays the approval of a device. On the other hand, if a company files a Class III device as Class II, this could cause them to have to perform additional testing that they had not accounted for. This could cause the project to go far over time and budget, which can be detrimental and even cause potential failure. These are all avoidable risks if companies do their research and consult with experts early on, allowing themselves to plan and budget for the correct regulatory requirements. 

@mjc22 Hi there! I agree with you that filing for FDA approval of a misclassified device can cause major hinderances to the entire process. I can recount a personal experience with this. While I was interning in a small startup over the summer, I was involved with an orthopedic device made from polymers that featured bioresorbable characteristics, complicating its classification. At first, we believed it would be categorized as Class II because of its resemblance to current bioresorbable implants; however, due to its unique degradation characteristics and possible systemic impacts, there was a real compelling case for Class III. I remember having a meeting with my coworkers how a major issue with an erroneous classification submission is the likelihood of serious delays in our company. If you file as Class II and the FDA classifies it as Class III, you will have to undergo a more stringent PMA process, prolonging approval by several years! Conversely, if you file early as Class III but it is later classified as Class II, you will have spent time and resources on excessive testing that wasn't needed. There’s a strategic benefit to over-classifying instead of under-classifying though in my opinion, since it’s simpler to downgrade than to upgrade. Unfortunately, however it still results in wasted resources and possible investor worries about extended timelines.

I agree, filing in a wrong classification could result in significant delays and could also lead to financial burdens depending on the class type. Filing a Class III device as Class II is riskier, as the FDA may require more testing, delaying approval and potentially risking patient safety. 

This could raise concerns about patient safety and force the company to restart parts of the approval process. To prevent such issues the companies should have early communication with the FDA through pre-submission meetings allowing for clarification on classification and regulatory expectations reducing the risk of costly reclassification. 

I agree that the largest challenge that would come with misclassifying a device is stunting your timeline. Additionally, more resources and a deeper budget may be necessary to complete additional testing for a misclassified device. I think filing for a lower class device and being told the device actually is a higher class would have the most impact on your project. If you classify your device as higher than it could be, you likely were already planning for extensive testing which may not be necessary if the FDA classifies your device lower. If you did not anticipate clinical tests and then are told that you need it for your device, that would blow up your entire project timeline and budget. 

Misclassification of a medical device occurs when it is assigned an incorrect regulatory category, leading to compliance issues and potential safety risks. This can result in inadequate testing, improper labeling, or failure to meet necessary regulatory requirements. Misclassification may lead to delays in market approval, product recalls, or legal penalties for manufacturers. Ensuring accurate classification requires thorough understanding of regulatory guidelines, intended use, and risk levels associated with the device. Proper classification helps streamline regulatory approval, ensuring the device meets safety and performance standards before reaching patients.