Tips to Stay Away from Pitfalls When Planning a Pre-Sub or Q-Sub Strategy for FDA Submissions

Introduction

When submitting a pre-submission or Q-submission, asking the right questions to the U.S. Food and Drug Administration (FDA) is vital while seeking feedback. I suggest thoroughly reviewing the FDA Q-Submission Program. Poorly formulated questions can lead to suboptimal responses. Inadequate planning can cause to spot and fix possible problems with a device filing. Lack of preparation is a failure to zero in on the potential best regulatory approach.

A thorough preparation for pre-submission is a must in acquiring valuable insights from the FDA. This initial work can speed up the whole product development process. Manufacturers can confidently proceed to the next step with a more efficient and practical approach to product development by asking the right questions.

Suppose your organization deals with medical devices or in vitro diagnostics. In that case, you can benefit from the FDA’s Pre-Submission Program. This program can provide valuable feedback from the FDA for specific regulatory steps.

FDA is well-known for offering feedback on proposed bench, pre-clinical, or clinical programs. Their review can help a device’s planned regulatory strategy. The FDA can also talk about predicate devices that have already been chosen and decide if the products that go with them are acceptable.

Pitfalls to Avoid

Companies must take the Pre-Sub Program seriously because device makers often make serious mistakes, especially when they submit questions that aren’t well thought out. To maximize their time with the FDA, groups should make the most of the chance to ask well-thought-out pre-submission questions that give valuable and relevant information.

However, many manufacturers often don’t do enough as they provide short and pointless descriptions of their products, vague details about how they work, and data that fails to demonstrate how their products differ from similar ones on the market. This approach will yield inaccurate feedback. However, companies can save significant amounts of dollars and time during the development phase simply by asking the right questions.

Example of Pre-Submission Questionnaire

Suppose you want to submit your device to the FDA. In that case, it is imperative to provide detailed information about the device, including its history, usage data, and potential concerns. It’s also important to look at past development programs and explain how you plan the regulatory strategy. To help you prepare for a Pre-Submission meeting, consider the following questions -

Question 1

Insufficiently Formatted Question: Are the proposed biocompatibility studies sufficient to support the clinical trials?

Improved Question: It is clearly stated that the biocompatibility testing for the device will follow the recommended protocol that is used for devices with limited blood contact. The design team will use industry-standard materials for the device. The team will follow the standard manufacturing process. Therefore, there is no need for carcinogenicity testing. I would appreciate hearing the FDA’s perspective on this issue.

Question 2

Insufficiently Formatted Question: Would the FDA consider this device suitable for the De Novo pathway?

Improved Question: We investigated the FDA database extensively but found no current predicates for our device. Nonetheless, our product is made of low-risk ordinary materials like water and salts. As a result, it qualifies for a De Novo request. Our product has been proven to be biocompatible. Furthermore, the earliest Good Laboratory Practices (GLP) reports have demonstrated its safety. Again, scientific trials involving over 2,000 patients have proved that our technology is safe and effective. Given the supporting evidence, we’d like to know if the FDA agrees that a De Novo submission is the best regulatory route.

Question 3

Insufficiently Formatted Question: Can this device be used for the De Novo pathway as per FDA guidelines?

Improved Question: A primary predicate device shows how the Alpha Graft is substantially equivalent to the predicate. Alpha Graft was chosen as the primary predicate based on its indication for use and technology (absorption over time). We have also proven that this device is the same as other 510(k)-approved devices that use the same technology or have the same usage. The Alpha Graft is compared and contrasted with already cleared graft material in Section 3 of the Pre-Submission form. We think that the material is an appropriate predicate. Are there any other suggestions for a predicate device that the FDA may have?

Question 4

Insufficiently Formatted Question: Does the FDA agree with the proposed Modular Pre-Market Approval (PMA) strategy?

Improved Question: Section 5 of the Pre-Submission packet states that we plan to submit N (specify the number) of PMA modules.

• The first module, due in January 2024, will contain pre-clinical testing results, including biocompatibility, sterilization, and bench testing.
• The second module will include manufacturing information.
• Section 6 of the Pre-Submission packet states that the third module will contain literature, U.S. data, and OUS data.

We will use literature to support the device’s application to individuals over 85 years old. The U.S. and OUS data were collected using the same protocols and criteria as the predicate device. The data will be presented per the IDE Number. We will also provide sales and complaint data, as the device has been commercially available in Canada since 2017. Do you agree with this approach for module three, FDA?

Conclusion

The FDA can provide accurate, valuable, and actionable feedback. But device makers must ask clear, well-thought-out questions.

Essenvia is the market leader in facilitating pre-submissions with a single-click submission platform. The team utilized the FDA-specified interactive Pre-Star PDF Template. Our team has spent countless hours researching. We developed a platform that helps medical device makers with PreStar and eSTAR.

Essenvia knows how to gain relevant input from the FDA, often resulting in faster submissions and quicker product approvals. For more information, please get in touch with support@essenvia.com.