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Medical Device 510(k) Submission Consulting for FDA Clearance

Every year the US FDA “approves” more than 2,000 traditional medical device FDA 510(k) submissions. A significant number of additional FDA submissions are rejected or abandoned by the manufacturer because the required testing was not conducted, guidance was not followed, or other requirements were not met. 

Our highly experienced 510(k) consultants will increase your chances of getting FDA approval, and get it done faster

If you have a medical device that’s ready for commercialization, Oriel STAT A MATRIX can help you navigate the FDA approval (clearance) process. We specialize in medical device compliance and our team of 510(k) consultants understands how the FDA process works and what pitfalls to avoid. As a result, we can generally prepare and submit your 510(k) application more quickly, with less chance of receiving an initial “Refuse to Accept” rejection or an Additional Information (AI) request from the FDA reviewer. Faster clearance from FDA means your device is generating sales sooner.

We achieve positive results using a proven process for preparing your 510(k) Premarket Notification to FDA

We are meticulous about preparation, and emphasize it because we have learned that spending time on preparation results in a higher rate of successful 510(k) submissions at less overall cost to our clients. Here's how we will approach your medical device 510(k) application:  

  1. Confirm your FDA product code, regulation number, and predicate devices. This is crucial. If the wrong product code is chosen, it can lead to rejection of your FDA 510(k) application and months of lost commercial sales. Identifying the correct predicate devices against which you will compare your device is also critical and must be done with care. 
  2. Identify all testing, FDA guidance, consensus standards, and clinical data requirements. The FDA website contains a wealth of information, but it can be overwhelming. This is where having an experienced 510(k) consultant on your side can pay off. Each product code lists FDA guidance documents and/or consensus standards associated with that device. We will research all standards and guidance documents to be followed, along with testing and clinical data requirements to be met, if applicable.
  3. Prepare a detailed gap analysis report to provide a clear pathway for 510(k) submission. With requirements identified and an assessment of your current documentation complete, we will provide you with a detailed gap analysis report showing what information you have now and the data you still need to obtain for a successful 510(k) submission. We will then educate your team on the testing that will be required along with clinical data to be collected, if applicable. 
  4. Compile and submit the FDA 510(k) application and handle post-submission questions. Once all the missing data and testing pieces have been assembled, our FDA consultant will prepare all 20 sections of your 510(k), submit it to FDA, and answer follow-up questions that arise from the FDA reviewer. “Additional Information (AI)” requests are common, but we aim to minimize these by ensuring that all sections of the 510(k) are complete and include all required data as stated in consensus standards and guidance documents. This is the point at which preparation pays dividends in the form of speedier approval.

How long it will take to clear your medical device 510(k)

Even though FDA has a published goal to clear most 510(k) submissions within 90 days, those are working days and not calendar days. Also, if the FDA reviewer issues an AI request post-submission, their internal review clock stops and does not begin again until you provide them with the requested information. As such, the majority of medical devices clear the FDA 510(k) review process in 4-8 months. Simpler devices with limited testing requirements and well-known predicates will be on the short end of that range; more complex products on the long end.

Contact us for more information or a proposal on preparation of your 510(k) application to FDA.

Select a course below to learn more or to register.
 
Course Name Public On-site
US FDA 510(k) and EU CE Marking Medical Device Registration Strategy Training

Learn how to identify an appropriate regulatory pathway to obtain product approval or clearance in the United States and/or the European Union (EU). Click to learn more.

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