Submitting innovative medical products to the U.S. Food and Drug Administration Center for Devices and Radiological Health is a complex and lengthy undertaking that generally begins late in the product development process. Organizations set up their portable medical devices to successfully pass over the regulatory hurdles by approaching each task with careful research and preparation. Here are four considerations that can make the difference in moving to the next step of bringing a medical device to market:
1. Prepare your strategic resources
"Cutting corners will leave a product mired in delays."
The biggest mistake a company can make in submitting a device for FDA clearance is failing to plan ahead. As Medical Design Technology noted, approaching the submission without the proper resources for strategic planning and just hoping for a quick approval process is unlikely to work out. The FDA is only interested in confirming the safety and effectiveness of the device, not the needs of your business, and cutting corners will leave a product mired in delays.
Companies are more successful at passing the submission process when there is a person in the organization dedicated to understanding regulation and working closely with the FDA. This individual, often the Vice President of Regulatory, can guide the device through every step of the approval process and engage directly with the CDRH when necessary. If any questions or problems arise about the product's classification and suitability for clearance, this regulatory expert will be positioned to resolve them as quickly as possible.
2. Choose the right classification and submission path
One of the most important questions a manufacturer must address when submitting a medical product is how the FDA will classify it. While the regulators determine the official classification for the device, knowing how the product will likely be classified and choosing the appropriate submission path leads to a much smoother process. Understanding some key aspects of the classification system, as outlined by the FDA, may save a great deal of time and money:
- Medium- (Class II) and high-risk (Class III) devices must be approved, which involves presenting evidence to demonstrate the product is safe and effective, or cleared, meaning they are found to be sufficiently similar to another product already approved.
- Low-risk, or Class I, devices usually do not need to go through these steps.
- Most medium-risk devices are cleared through the 510(k) Pre-market Notification process, in which the maker demonstrates the new product is equivalent to another that has already been cleared.
3. Don't make too many claims
Consider carefully what claims to make about the device's capabilities and how to word them, as these assertions can have major effects on the submission path. Know what standards have been established for the type of device you are submitting and tailor all statements accordingly. After all, the maker must back up those assertions with clinical evidence to be carefully evaluated by regulators.
The claims a manufacturer presents about the medical outcomes of using a device can alter the classification and make it much more difficult to achieve clearance. For that reason, it's best to keep statements about a product's effectiveness limited and conservative, especially in an initial application. After the device has been approved with a more general statement of its uses, it's possible to file another submission with more extensive clinical data to support further claims.
4. Include all necessary information
Closely review the FDA's refusal-to-accept checklist before submitting an application. Medical Device Academy suggested creating a template for submissions, which will minimize the chances of making one of the many simple errors with the potential to needlessly delay approval. Some of the items that can lead to an immediate rejection of a 510(k) submission include:
- Sending supporting content not written in English.
- Failing to include an "Indication for Use Statement" designating over-the-counter or prescription use.
- Omitting clinical data.
- Neglecting either to identify any past submissions of the same product or neglecting to state that there have been no previous submissions.
- Including descriptions in different sections that are inconsistent with one another.
- Providing insufficient justification for stating the new device is substantially equivalent to one approved in the past in terms of both its uses and the technology employed.
If medical device design firms have not done their homework, submitting their work to the FDA for approval or clearance can be a drawn-out and expensive undertaking. However, with a deep understanding of the applicable regulations, a thoughtful strategy and attention to detail, an organization is on much stronger footing. A readiness to navigate regulations is one of the key factors in successful medical product development.