A premarket submission made to the FDA demonstrating that the device is at least as safe and effective, Substantially Equivalent (SE), as a legally marketed device that is not subject to PMA. It is a key pathway that any medical device manufacturer planning to market in the U.S. must understand.
Predicate Device
Predicate devices are legally existing products that have already been cleared by the FDA under 510(k) subtypes The new device must have the same intended use and technological characteristics as a predicate device to be able to use a predicate device. If it differs, the new device must show that such a question of safety and effectiveness is not raised.
Substantial Equivalence
The new device is at least as safe and effective as the predicate, To demonstrate substantial equivalence, the manufacturer must relate their device with that of the predicate based on intended use, technological characteristics, performance data and safety & effectiveness. These comparisons are reviewed by the FDA to determine if they allow for clearance of a new device.
De Novo Submission
De Novo submission is a different regulatory pathway for new medical devices that are not predicate devices. The De Novo process is different from the 510(k)-precertification program, but it represents an alternative route for those low- to moderate-risk products that otherwise would not have a predicate. This path would create a new device classification, making the 510(k)-option available to future devices that reference the newly established classification.
Why 510(k) Consultants?
Why Hiring 510(k) Consultants is Useful in Managing Regulatory Complexities:
- Knowledge: Consultants are experts on FDA regulations and submission requirements.
- Efficiency: They reduce wastage from both the submitter and the reviewers by ensuring that all documentation has been uploaded in full with accurate testing content.
- Risk Mitigation: Consultants identify and take care of potential issues before submission is made, mitigating the risk of hold-ups or rejections.
Cost of 510(k) Submission
Submitting 510(k) costs anywhere from $20,500 to over $40,000 depending on the complexity of the device and any associated testing or clinical data requirements as well if you use external third-party service or FDA review fees from $6,000 to 22000. In addition, cost of testing and additional charges extra
510(k) Submission Process
This contains a few key steps of the 510(k)-submission process:
- Establish Predicate Device: Identify a predicate device with which to compare.
- Gather documentation (device description, intended use, performance data and substantial equivalence comparison) to prepare the submission.
- Submit 510 (k) application authorization in the Required fee along with the Application.
- The FDA reviews the submission, often followed by requests for more information or clarification.
- If the device is determined to be substantially equivalent, the FDA gives 510(k) clearance.
510(k) Clearance and Benefits
The FDA 510k Clearance allows the manufacturer to market its device in the United States. 510(k) Clearance Features and Benefits:
- Market Entry (Market), U.S. medical device market, which has the highest value.
- Gives a Competitive Edge: Idea regulatory observance alternates the enterprise standing order to higher-competitive rank.
- Investor Confidence: FDA clearance may induce investment as it confirms that the device is safe and performs under its intended use.
Conclusion
The FDA 510k submission process is an important pathway to market for you, as a medical device manufacturer looking towards the U.S. Through establishing substantial equivalence to a predicate device, manufacturers can bring products that are proven safe and effective via the regulatory process. However, one of the benefits gained from using 510(k) consultants is that it speeds up and de-risks your submission to make clearance easier, resulting in a market access advantage over other competing products.