What is an RTA?

In the context of medical device Regulatory Affairs, a Refusal to Accept (RTA) is a request from the US FDA for additional information or clarification on information submitted in a 510(k) application.

What is a 510(k) Application?

A 510(k) application is a premarket submission made to the US FDA to demonstrate that a medical device is substantially equivalent to a legally marketed device and does not require premarket approval. The FDA reviews the information submitted in a 510(k) application to determine if it is complete and provides sufficient evidence to support clearance of the device.

If the FDA determines that additional information or clarification is needed to decide on the 510(k) application, it will issue an RTA. Receiving an RTA can delay the clearance process and result in additional costs and resources for the medical device manufacturer.

Most of the refusals are due to small reasons. Here are five tips to help avoid an RTA during the 510(k)-clearance process:

• Thoroughly follow Regulatory requirements: Before submitting your 510(k) application, it is important to thoroughly research the Regulatory requirements for your specific device and ensure that your application meets all of these requirements. This involves following the relevant FDA guidance and RTA checklist, as well as utilizing the FDA Q-submission program.
• Accurate Classification of 510(k): Pre-market submissions are of three (03) types named as, Traditional, Abbreviated and Special 510(k). The intended use of your device is one of the most important aspects of your 510(k) application. It is important to clearly define the intended use of your device, including what it is designed to do and what it is not designed to do. This will help to ensure that your device is classified correctly.
• Choose the correct predicate device: The FDA typically requires that 510(k) applicants demonstrate that their device is substantially equivalent to a legally marketed predicate device. It is important to carefully evaluate the appropriate standards and predicate devices to use for your device and to provide a comprehensive comparison between your device and the predicate device in your application. You can review current devices and their information by searching the FDA’s medical device databases.
• Provide comprehensive test data: Your 510(k) application must provide data about the safety of the device (cyber security, shelf-life, biocompatibility, Electromagnetic compatibility (EMC)) or other verification and validation documents.
• Avoid discrepancies in information: It is a must to maintain consistency throughout the 510(k) application. For example, the indication for the ‘use’ statement comes up multiple times in the document. It is extremely important to keep the wording consistent even if the intent is unchanged.

By following these tips, you can increase the chances of a smooth and efficient 510(k) clearance process and avoid an RTA. However, it is important to remember that each device and each Regulatory situation is unique, and it is always best to consult with Regulatory experts or the FDA for specific guidance on your device and application.

For further information and queries about the 510(k) application process and other services pertaining to device registration, schedule a call with our Regulatory experts.