Get on the Right Regulatory Path for 510(k) Submission!
Medical device manufacturers, who intend to market devices in the US, are required to be compliant to FDA regulations pertaining to medical devices. Specifically, the FDA has identified premarket notification requirements that manufacturers must adhere too, which are based on the risk level of the medical device. For example, a 510(k) premarket notification may be required for a medical device. A 510(k) is a submission made to the FDA that demonstrates that a device is at least as safe and effective, that is substantially equivalent, to a legally marketed device, known as a predicate device. The manufacturer is required to receive clearance from the FDA for this 510(k) submittal prior to commercial distribution in the US. Have you submitted your 510(k) to the FDA yet? If not, A Wright Path can help.
Our 510(k) Submission Services
At A Wright Path, an FDA regulatory consultant can help you navigate the 510k process by:
- Conducting a thorough review of your device to determine the appropriate regulatory pathway.
- Preparing your 510(k) submission in accordance with FDA requirements, including those specifically applicable to your medical device.
- Submitting your 510(k) to the FDA and serving as the official contact person on your behalf.
- Communicating directly with FDA personnel with respect to your 510(k) submission and addressing any requests for additional information.
- Preparing any responses to the FDA in a timely manner for when additional information is requested.
Who Must Complete a 510(K) Submission?
The FDA identifies the following four categories of who must submit a 510(k) prior to introducing a device to the US market:
1. Domestic manufacturers introducing a device to the US market.
2. Specification developers who develops the specifications for a finished medical device, but has the device manufactured under contract by another entity.
3. Re-labelers or re-packers make labeling changes, or whose operations affect the device.
4. Foreign manufacturers/exporters of US representatives of foreign manufacturers/exporters.
Do you know which category you fall under?
See how we’ve brought our Partners Success
With strong and solid industry expertise, A Wright Path® navigates and executes the FDA & global regulatory requirements from design to approval, enabling our clients to confidently launch their products into the marketplace.
We can help you with your 510(k) submissions.
We have implemented a 2 phase approach to determine the regulatory pathway to the US market for your device.
Step 1: PREPARE A REGULATORY STRATEGY
- Assess similar devices previously cleared by the FDA to determine your predicate device.
- Prepare a regulatory strategy outlining the required testing to be included in your 510(k).
- Identify all required documentation, including device labeling, necessary to complete your 510(k).
Step 2: PREPARE 510(K) SUBMISSION
- Prepare all the 21 sections of the FDA 510(k) application.
- Prepare the complete 510(k) in accordance with all FDA requirements, including the Refuse to Accept checklist.
- Once approved by you, we submit the required copies of the 510(k) to the FDA for review.