Compliance with US FDA regulations is mandatory for marketing and distributing medical devices in the U.S. The US FDA 510(k) approval process authorizes the marketing of medical devices in the US. Timing, completion, and accuracy are of paramount importance in regulatory submissions. In this blog, we have highlighted the importance of strategic timing of US FDA 510(k) submission.
What is US FDA 510(k)?
US FDA 510(k) is a premarket notification process used to demonstrate the device in question is as safe and effective as the “substantially equivalent” device being sold legally in the US. This process involves evaluating and comparing the device with the “substantially equivalent” device already being sold in the US market. This similar product or “substantially equivalent” device is known as a predicate device. The 3 types of US FDA 510(k) are as follows:
- Traditional 510(k): This is the original 510(k) and can be used in any situation.
- Special FDA 510(k): This type of FDA 510(k) is required when there is a modification in the device but the modification will not impact the intended use of the device.
- Abbreviated FDA 510(k): When the submission is based on FDA guidance documents, demonstrates compliance with special controls for device type, or follows a voluntary consensus standard.
Notably, choosing appropriate timing of US FDA 510(k) submission is crucial for a successful application.
How to identify a suitable predicate device?
A predicate device is an FDA-cleared medical device that will be used for comparing your new device. Use the FDA’s product database and three-letter product codes to find a suitable predicate device for your US FDA 510(k) application. We have mentioned some points to keep in mind when choosing your predicate device.
- Intended use: Both the predicate and new device should have the same intended use.
- Technology: Similarity in design, functioning, and materials between both the devices.
- Safety and performance: Safety and performance of both the predicate and new device should be comparable.
Requirements for 510(k) clearance
The following basic information will be required for securing 510(k) clearance:
- The device classification
- The device’s name
- Actions taken to abide by performance standards
- Location the device will be launched in the market
- A comparison with other similar devices
- Clinical trial data, if applicable
- Potential ideas for labels and advertisements that will properly demonstrate the device’s use
- A financial certification
Devices covered
US FDA 510(k) covers low-risk Class I and II medical devices. These devices must have a substantially equivalent predicate device. Furthermore, if a significant change is introduced to a legally marketed device, a US FDA 510(k) premarket notification will be required. A modification that could substantially affect the device’s safety, effectiveness, or intended use will be considered a “significant change”. Moreover, domestic medical device and IVD manufacturers who are trying to introduce new devices to the US market will have to secure the FDA 510(k) clearance. Additionally, re-labellers or re-packers who make device labelling changes will also require this clearance.
US FDA 510(k) process
US FDA 510(k) is a premarket notification having a specific format. The progress is less rigorous and cumbersome. The applicant is required to demonstrate the new device is substantially equivalent to a legally marketed predicate device. The application should be used to prove the new device is as safe and effective as the predicate device.
The US FDA 510(k) submission must be sent to the appropriate FDA centre. The regulatory officials will validate the comparison providing evidence for substantial equivalence claims. Until the applicant has received a response from the FDA confirming their device’s clearance, they are not permitted to market their device.
After reviewing the application and verifying the document, the FDA will clear the device for sale and marketing in the US. Additionally, they will issue a 510(k) number. Then, the number with device details will be uploaded on the 510(k) database.
Ideal timing of US FDA 510(k) submission for different scenarios
We have presented the ideal timing of US FDA 510(k) submission for different scenarios.
- Launching a new device: The ideal timing of US FDA 510(k) submission when launching a new device is after completion of testing and documentation. However, this should be done prior to commercial distribution of the medical device.
- Modifying an existing device: Prior to rolling out changes that affect safety, performance, or intended use of the device.
- Entering new markets: US FDA 510(k) submission should be aligned with product launch plans in new markets to avoid regulatory bottlenecks.
- Post-clinical trials: As soon as clinical trial data is validated it should be incorporated into the US FDA 510(k) submission.
Why does strategic timing of US FDA 510(k) submission matter?
- Early market entry: Submitting your application early allows you to beat competitors to market, especially in segments, such as wearables or diagnostics.
- Reduced risk of refuse-to-accept (RTA): A well-timed submission ensures your documentation is complete and aligned with FDA expectations. This help reduces chances of RTA holds or rejections.
- Faster FDA review: Submissions during less congested FDA review periods (e.g., avoiding year-end rushes) can lead to quicker turnaround times.
- Cost efficiency: Delays in submission can lead to missed revenue windows, increased holding costs, and wasted marketing spend.
- Smooth regulatory journey: Strategic timing allows for better coordination with clinical trials, manufacturing scale-up, and distribution planning. Additionally, a complete and organized 510(k) reduces the risk of confusion with the FDA.
- Reduced risk of rejection: Accurate documentation minimizes queries, errors, and reduces risk of rejection.
- Efficient review: Timely applications provide the FDA sufficient time for thorough review without unnecessary delays.
- Faster clearance: Strategic timing of US FDA 510(k) often leads to faster approvals, thereby helping you enter the market earlier.
When is a US FDA 510(k) submission required?
The FDA mandates that the US FDA 510(k) application be submitted 90 days before you plan to commercially market the medical device in the US. A 510(k) submission is typically required in the following cases:
- Launching a new medical device in the US market.
- The intended use or indications of an already cleared device is changed.
- Significant modifications in design, material, or performance.
3 Pro tips for suitable timing of US FDA 510(k) submission
- Submit at least 90 days prior to planned commercial distribution to meet FDA expectations.
- Coordinate with your internal teams to align regulatory timing with business goals.
- Avoid submitting the application too early. It can lead to premature applications that lack complete data and will lead to costly rework.
Pharmadocx Consultants: Best US FDA 510(k) consultant
Navigating the complexities of the FDA 510(k) can be tricky. Moreover, the strategic timing of US FDA 510(k) submission is extremely vital. Thus, support from a US FDA 510(k) consultant can help you easily navigate the FDA’s 510(k) clearance process. We at Pharmadocx Consultants specialize in FDA 510(k) submission. Our team of seasoned professionals is well-versed in FDA regulations and submission requirements. We will leverage our expertise to help you achieve the approval and registration in a seamless manner.
Moreover, owing to incorrect application, thousands of FDA 510(k) are rejected. Furthermore, in certain cases, the applicants cannot complete their application, as the process is difficult. The Pharmadocx Consultants team is committed to provide proper guidance to their clients to help them successfully secure the approval. As a reputed US FDA 510(k) consultant, we follow a unique approach that helps our clients achieve the approval effectively and efficiently. Moreover, we tailor our services as per client requirements. To avail our services, email at [email protected] or call/Whatsapp on 9996859227.
