When Should A Device Regulatory Path Be Discussed?

In today’s quest to get a device to market things move pretty fast and people wear many hats. In this the regulatory path is often ignored during the design and development phase. The regulatory pathway is an essential part of device development that needs to be discussed early in the project plan design stages. This discussion will help with developing accurate project timelines and projected costs, as well as allocating appropriate regulatory resources. Some questions that definitely need to be answered early are:

• What is the intended use? What are the indications for use?

The answers to these two questions will determine the risk class of the device, potential predicates and whether a submission is necessary. It's a must to understand the intended patient population that will be targeted and what the device is intended to do.

• What is the device description?

The device description determines claims and helps with predicates, product codes, performance testing etc. All of these help determine the regulatory path. But as the design process progresses over time the description may need to be updated if the device capabilities change.

• What is the predicate device?

Determining the predicate device(s) will give you the basis to establish equivalence with respect to: intended use, product code, design, claims, performance, safety, effectiveness, labeling, biocompatibility, standards, and other applicable characteristics. You may use a predicate that is already being marketed by your firm. If this is the case then the standard review time will be shorter.

• Are there applicable guidance’s that can be utilized?

Guidance for Industry documents are developed for FDA staff, regulated industry, and the public that describe the agency's interpretation of or policy on a regulatory issue. There are also specific guidance for some devices that should be followed so be on the look out for those.

• Are there standards the need to be followed?

Depending on the type of device there may be applicable international and FDA recognized standards that need to be followed. Some of these standards test for biocompatibility, electrical interference, packaging/transport and sterilization to name a few. Unless your company has the in-house capability to test to these standards this type of testing should be considered from a budget perspective as well as lead time of the testing house.

• Is clinical data needed?

Performance testing data is required for all traditional 510(k)s. The FDA also mandates that some device types require you to submit clinical performance data to establish equivalence. Clinical data collection can be a lengthy process so it is best to determine this very early in the process.

If these questions are answered and documented in a regulatory plan early in the development process the regulatory path can be an easier road to navigate and may not result in many requests for Additional Information (AI) from the FDA.

Our advice is to bring a regulatory professional into the device development process as early as possible. If your company does not have an in-house regulatory team then let O’Connell & Myers, LLC guide you through the rough waters of the 510(k) submission process.