Section 510(k) of the Food, Drug, and Cosmetic Act from the Food & Drug Administration (FDA) requires device manufacturers to notify the FDA of their intent to market a medical device. 510(k) approval is mandatory and one of the most essential regulatory hurdles in bringing a new or updated device to market. Products and companies sink or swim depending on how the 510(k) approval process plays out. Lives and livelihoods can be greatly impacted.

For medical device manufacturers, the FDA 510(k) submission requires significant resources and attention. But for organizations focused on innovation and speeding up time to market, understanding where you currently are in the 510(k) process, as well as what other priorities you should be focused on, is of the utmost importance.

Although there are many instances when these steps overlap, here’s a closer look at the four critical stages in the 510K approval process, and how device manufacturers and their partners can accelerate time to market.

1. Pre-510(k) Submission

There’s a lot of preparation that comes with bringing a big idea to life and preparing it for the scrutiny that comes with an FDA review. Much of the work at this phase is part of the clinical evaluation process as well as building out a project timeline.

The 510(k) submission preparation stage entails identifying most, if not all, vendors, parts, resources and partners for testing and validation. This also includes securing cleanroom space and sterilization validation tools for clinical testing. As bench-top testing is completed, teams can shift their focus to packaging and preliminary testing. It’s also the right time to start finalizing documentation and other materials that will be used in the 510(k) submission and for future regulatory and product launch purposes.

2. Post-510(k) Submission

There are plenty of ways for medical device creators to proactively speed up time to market while awaiting feedback from the FDA. At this stage, with the design frozen, an accurate Bill of Materials and engineering/manufacturing instructions should be in place. With that foundation, manufacturers can move to ticking off project management tasks, including establishing a quality system and creating quality folders for each vendor or materials provider. It’s also the time to start validation and real-time aging tests.

Often, the time between 510(k) submission and approval is a good time to sure up relationships and agreements with contract manufacturers or other providers. This includes aligning on basic pricing and services provided, as well as building out a more detailed quality agreement.

3. 510(k) Approval

Receiving that official approval from the FDA offers a rewarding validation of your work to date. It also kickstarts a whole new phase of manufacturing processes. The first post-approval step is to ensure all previous activities are completed and accurate – the quality agreement should be signed, and a manufacturing agreement should be close to finalized. Make sure all validations and supporting documentation is completed. Only then can organizations prioritize purchasing materials and ensuring adequate inventory levels, supported by a comprehensive Enterprise Resource Planning (ERP) system with appropriate lead times, stock levels, and more.

4. Ramping Up Manufacturing

With the approval and related preparations in place, organizations are well-positioned to shift their focus to internal or partner manufacturing. At this stage, a partner like Life Science Outsourcing will create a detailed proposal and will have conducted a successful customer-supplier audit. Transfer valuations will be underway, and employees will have been hired and undergo training from the contract manufacturer and the device creator.

The above steps are designed to offer helpful markers in the process. But it’s important to note that despite rigorous regulatory requirements, the path for each organization may look a little different. Action items may overlap with various steps or be completed in a slightly different order. Working with a proven manufacturing partner can help streamline the process and identify when deviations could lead to challenges down the road.

Life Science Outsourcing has decades of experience serving device manufacturers as they navigate medical package testing requirements and related standards. That includes providing services based on each stage of the 510(k) process, ensuring the submission goes smoothly.


To learn more about our Medical Device Manufacturing services, be sure to visit our FAQ page or contact a member of our team today.