Regulatory considerations might not seem to be the highest priority when you’re in the early stages of developing a medical device, and it can seem like a daunting task.

Fortunately, although your product is likely to have unique features, it’s also likely that there will be some previously developed products that are related in some way – for example, in the technology, format, indication or patient needs. So, discovering the compliance pathway that those devices followed is a good starting point for your own regulatory journey.

Resources on medical device compliance

But where to start?

With the US market the top priority for many, two large and publicly available resources on regulatory submissions to the US FDA are especially helpful:

• Devices@FDA catalogues all 510(k) premarket notifications and PMA premarket approvals for medical devices since 1976.
• The De novo database lists all de novo classification orders since 2012, for devices of low to moderate risk considered to be ‘not substantially equivalent’, either by the sponsor or following a 510(k) submission.

Both databases are updated weekly, and in addition to basic information such as the device description, device classification, and the applied standards, they contain data on indications and contraindications for use, potential hazards, and the scale of non-clinical tests and clinical studies conducted for design validation. The last point is particularly important, because the number of devices used in these tests provides pointers to the scale of the manufacturing setup that will ultimately be needed for your device.

Having said that, interrogating the databases requires some experience and prior knowledge, especially because they don’t support searches for device-type keywords. It is worth investing some time to become familiar with similar or competing devices, so you can search the database to gain real-world data about what works, and to gain insights into the process that the manufacturer went through in order to achieve acceptance. The De novo database is particularly interesting, because by its nature it contains more upfront detail about the novel innovations, rather than referring back through a chain of previous similar submissions.

Understanding the standards landscape

But what about the standards that you might be asked to show compliance with?

In addition to the standards that are required for all medical devices (ISO 13485, ISO 14971), there are general standards, covering domains such as software (IEC 62304), general safety (IEC 60601), biocompatibility (ISO 10993), or implantable devices (ISO 14708), that provide the entry point and framework for working in those domains.

As another layer, there are collateral standards that include guidance for specific hazards (e.g., IEC 60601-1-11 for home healthcare) and particular standards for specific device types (e.g., ISO 14708-2 for cardiac pacemaker). Each layer of standards is generally additive and augments the general standards to provide a complex set of requirements for your medical device.

Understanding the breadth of standards that you’re likely to comply with at an early stage of product development can help to reduce the overall effort needed, by reducing the number of design iterations as new standards or requirements are uncovered. It also increases the likelihood that you’re successful when you ultimately submit your design evidence to a regulatory body.

Where standards do not exist, for particularly novel features or devices, the backbone of medical device development is the ISO 14971 risk management process to determine what risk are or are not acceptable, and what requirements and tests are needed to mitigate these. This process is undertaken as part of your device development, and a close collaboration between technical, regulatory, and clinical experts is essential to avoid pitfalls, and to manage the technical trade-offs and clinical risks of your device.

Compliance research for compliance success

Rather than considering regulatory compliance as something to defer to during the later stages of a project, earlier is better. In the early stages, even a modest amount of research into the compliance routes taken by existing products, and the suite of standards that you might be asked to show compliance with, can help inform design decisions and allow you to plan for future compliance activities.

By reducing the risk of unpleasant surprises in the form of unexpected demands for testing, or the need for costly reworking, such actions ultimately allow you to tackle the whole process with more confidence, and so give your project a greater chance of success.

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