Don’t get Stuck on FDA

ECM notified body 1282

Regulatory Approval Time is crucial. Whether you assign a dollar value to it or not, your time is valuable to ECM. The values and work ethic displayed by a company’s decision makers have a direct influence on company culture, and many times, on business profitability. ECM strives to improve the efficiency and effectiveness of your business.

FDA Clearance: Medical Device 510(k) Submission Support

Every year the US FDA approves more than 2,000 medical device FDA 510(k) submissions. Nevertheless, a significant number of submissions are rejected or abandoned by the manufacturer because the required testing was not conducted, recommendations not considered, or other requirements were not satisfied.

With our robust 510(k) experience and expertise, ECM can support you in obtaining FDA approval, and getting it done fast

If you want to market your Medical Devices in the USA, ECM can support you through the FDA approval process. As a Notified Body ECM has developed a consistent experience in medical device compliance. Our 510(k) team can leverage our knowledge of the FDA process and guide you through the hazards and drawbacks. Faster clearance from the FDA leads to a faster access to the market and revenues.

Our proven methodology for preparing 510(k) applications
delivers a high rate of positive results.

Here is how we handle your medical device 510(k) application:

  • FDA product code confirmation, regulation number, and predicate devices. This is fundamental. If a wrong product code is selected, the result will be a refusal of your application.  Restarting the process causes a waste of time and loss of sales. Identifying the correct predicate devices for comparison is crucial and must be carried out with care.

 

  • Identify all testing, FDA guidance, consensus standards, and clinical data requirements. FDA provides an abundance of resource information. Reading, sorting and applying that information can be overwhelming. ECM’s experienced 510(k) team can guide you through maze of information. Each product code refers to specific FDA guidance documents and/or consensus standards related to that device. Our 510(k) team identifies all the relevant standards and guidance documents, along with testing and clinical data requirements to be satisfied, when applicable.

 

    • Gap Analysis report to provide a clear route for 510(k) submission. After step 2, ECM will provide you with a detailed Gap Analysis and roadmap for your team on the testing requirements as well as the clinical data to be collected, if applicable.

     

    • Compile and submit the FDA 510(k) application and handle post-submission questions. As soon as all the data and testing results have been gathered, our team will prepare all 20 sections of your 510(k), submit it, and answer follow-up questions from the FDA reviewer. “Additional Information (AI)” requests are common and part of the process, but we reduce this to the minimum by ensuring that all sections of the 510(k) are complete and include all required data.

Let's talk about

ECM America -Unit 506 – 1110 Brickell Avenue 33131
Miami, Fl

(833) 326-2378info@ecmmedicaldevices.com

ECM HQ - Via Ca' Bella, 243, 40050
Valsamoggia (BO)

+39 051 670 5141info@entecerma.it