Hello everyone and welcome back to another issue of MedTech Compliance Chronicles! We are now right on the heels of putting our medical device on the US market! There is still one critical topic to cover, however, before we dig into market applications, that is: Post-Market Surveillance. Given its name, you may be wondering why are we talking about “post-market” anything if we aren’t on the market yet? Well, that is an unfortunately common thought but a dangerous one to get trapped in. Although, in the US, specific post-market surveillance is not required of every device, if the FDA decides it is required for yours and you have not prepared for it, it could result in months of delays in market approval.
So, what is post-market surveillance? Well, in short, once a medical device reaches the market, the work of ensuring its safety and effectiveness does not stop. Post-market surveillance (PMS) is an essential process that helps manufacturers gather real-world data, detect potential issues early, and maintain the safety and efficacy of their devices. In today’s post, we’ll explore the regulatory requirements and practical strategies for implementing an effective PMS program, ensuring that your device continues to meet both regulatory expectations and patient needs.
Regulatory Requirements
Luckily for many manufacturers, post-market surveillance (PMS) in the US is significantly less burdensome than many other markets are currently becoming. The quality systems regulations (part 820 that we just spent half a year covering) cover the vast majority (and only permanent) PMS requirements in its complaints, nonconforming product and CAPA requirements. However, for any class II or III devices the FDA can request specific post-market surveillance in accordance with 21 CFR part 822. However, in general, the FDA only orders PMS for devices intended to be implanted for more than 1 year, have excessive pediatric use, be used to support or sustain life outside of a device user facility (i.e., outside of a hospital or physician’s office, etc.) or if the device is expected to possibly have adverse health consequences. It is that last part that is the “catch all” that gets most class III devices a PMS order.
If the FDA decides that your device is subject to post-market surveillance, they will send you a letter informing you of the decision. If your device falls into one of the categories listed above or is class III, you can probably expect a PMS order as a condition of market approval, hence why you should have a plan in order prior to submitting your application. If the FDA orders PMS for your device, there will state in the order a particular “surveillance question” that the PMS is supposed to address. They may list multiple surveillance questions.
Once you have received an official order to conduct PMS under part 822 there are a couple more administrative requirements in addition to conducting the actual surveillance. First, you must submit your plan as to how you will conduct PMS to the FDA within 30 days of receipt of the order. Your plan must detail how you will conduct the PMS, including methods of study, data collection and analysis. The plan must be capable of adequately addressing the surveillance question(s) (if multiple surveillance questions require different methods, multiple PMS plans may be required to address all surveillance questions). The FDA will communicate with you on the adequacy of your plan but once it is approved, you generally must begin the PMS within 15 months of receipt of the original order. After plan approval, you must send the FDA a general update report every 6 months for the first two years and annually after that until the final report is issued. The final report, detailing the overall results of the PMS and providing an answer to the surveillance question, shall be submitted no later than 3 months after collection of the final data point. Also note that if you are answering multiple surveillance questions with differing methods, you may require different reports for each method or surveillance question.
Components of a PMS Program
PMS can cover a wide range of topics, as broad as the entire medical field. However, there are some basic components that will be beneficial to all PMS programs. The first, as with most projects, are well defined scope, objectives and responsibilities. These can be particularly more difficult to manage with PMS than with internal projects as, depending on the method of PMS being utilized, there can be a lot of interfaces with external bodies (testing facilities, IRBs, regulatory authorities, etc.). Just remember that the overall objective is to answer the surveillance question. Your scope should follow logically from the surveillance question. It is the responsibilities where you will need to do your due diligence to make sure that studies have the necessary review and independence to be valid and also the right people working on them to drive them to completion.
The next two components applicable to all PMS are data collection and analysis. This is where a lot of the details about the PMS will come out. The particular method of PMS will heavily dictate how the data will be collected and the type of data that is collected will determine the appropriate means of analysis. Remember that the overall goal is answering the surveillance question(s). The data collection and analysis portion of the PMS plan will be one of the more heavily scrutinized portions because ultimately, the data and how it is analyzed will either provide the right type of information, and enough of it, to answer the surveillance question or it will not. If the data to be collected in the plan is lacking the appropriate information (either in type or quantity), then the rest of the PMS plan becomes a moot point. We will get into the methods of implementing PMS and some examples of the types of data that will go along with them in the next section. For the analysis methods, you must choose valid methods, which is discussed in general in this post on statistical techniques. Detail on specific techniques will require further research.
The final two portions of a PMS program are feeding the information gathered back into the risk management process and taking appropriate actions. The analysis of the PMS data should provide you with some worthwhile information on how your medical device is operating in the field. If all is perfect (rarely the case) then you could just submit the final report to the FDA stating that is the case and go back to the simple monitoring requirements of the QMS. It is likely, however, that you become aware of some type of issues with your device. The good news is, if the PMS plan is adequately designed, you should now have much of the data to begin revising your risk management documentation and working on corrective actions. Some examples of follow-up actions to PMS may include, for example, if surveillance data reveals that users are consistently misinterpreting instructions for a device, leading to incorrect usage, the manufacturer might decide to update the labeling or instructions for use. Alternatively, suppose PMS data shows that a particular component of a medical device is failing more frequently than anticipated, posing a potential safety risk. This information would prompt a review of the device's design. The risk management team might decide to redesign the component to enhance its durability, thus reducing the likelihood of failure. Whatever the specific case, the ultimate point of this final portion of PMS is to ensure that manufacturers are actually doing something with the information they collect through PMS orders.
Implementation Strategies
So, we have talked a lot about the regulatory requirements and requirements of the overall PMS program, but how do you actually perform the PMS itself? Thankfully, there are a host of implementation strategies that can fit a whole range of products, surveillance questions and organizational capabilities. When choosing an implementation strategy, first you must choose between whether you are going to perform any actual studies or testing or if the PMS will be entirely information based. From there, you will have a couple of different options for each path.
In cases where you have decided (or sometime the PMS order may specify it as required) that your organization needs to actively carry out a new study or testing, there are a couple of decisions to make. Initially, you will need to decide if your organization will perform the study or testing itself or if you must hire a 3rd party, keeping in mind that scientific validity is required for any study performed and so the proper independence and authority of investigators will need to be accounted for if deciding to perform internal studies. There are then many differing options for studies/testing available. You can perform full blown clinical studies, focused around the specific surveillance question. Alternatively, a close comparison if clinical studies are not feasible can be animal studies (though new editions of the ISO 10993 series are requiring that animal testing be minimized). Finally, there is additional laboratory or bench testing of the device. The choices usually come down to the specific surveillance question being asked. For example, if the technology in the device is new, a full clinical study might be necessary to learn about the device in use. Whereas if the technology is more refined but, say, uses a different material than predicate devices with similar technology, then an animal study evaluating biocompatibility of the new material may be all that is necessary. Additional testing may be chosen if the surveillance question is calling into question certain performance aspects of the device.
The other option for implementing PMS is an entirely information based strategy. This can involve more enhanced/active collection of feedback from customers, searching regulatory databases for your device and devices that use similar technologies for reported issues and searching scientific literature to determine if your device is up to the current “state-of-the-art.” These types of PMS are generally used more for when your device or devices similar to yours have recently exhibited possible trends of less serious issues or, if you are trying to expand the use of your product, to gather information on its performance in its new use environment, etc.
Conclusion
In the end, basic PMS for all manufacturers are embedded in the QMS requirements. Outside of the basic PMS requirements, the FDA can order PMS for specific devices. When the FDA gives such an order, they will present one or multiple surveillance questions which the PMS is supposed to answer. The manufacturer of the device in question must then develop a PMS plan to be approved by the FDA that will adequately address the surveillance question(s). In general, there are two types of PMS. Conducting actual studies or tests are common methods for higher risk devices or devices with newer technology while information based PMS tends to be more for lower risk devices or devices that have been on the market for a while and thus, have a lot of real world data already around them.
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