Swift IDE approval is possible when your submission convinces FDA that you know your investigational device well and you have robust bench and pre-clinical data to demonstrate the device is ready for further evaluation in humans. This calls for clear technical, not creative, writing. While certain scenarios do allow for a well-written rationale or data-leveraging, your IDE is not the place to weave complicated tales.
In addition to following the established FDA guidance on IDE content, we recommend using FDA’s interactive pre-submission process. Working with the FDA review team can help lay out the roadmap of detailed information that is expected for your device and clinical study. Ready to take FDA on your IDE journey? Here are five tips for a strong, approvable IDE submission.
1. Beneficial bench testing
Robust bench tests provide tangible evidence to demonstrate your device does what you say it can do. The “what” and “how” are important aspects of bench tests to ensure repeatability over numerous units; however, it’s critical to consider the “why,” or the clinical rationale, behind those tests, too. For example:
- If your device will be delivered to a distal region of the anatomy, ensure your bench model includes representative tortuosity and distance to prove it can get there.
- If the user will need to pull on the device to remove it, obtain tensile strength data to provide adequate confidence that the device can be reliably removed intact, without experiencing failures that could lead to an adverse event or unplanned surgical retrieval procedure.
- If any product components are subject to fatigue, carefully consider the expected clinical exposure of the product in the body and test the appropriate type and number of cycles in a representative environment (e.g., fluids, temperature). FDA wants to understand how the device will perform in a patient, and simulated testing on a benchtop model will provide the confidence they need to approve testing in humans.
2. By the book biocompatibility
Biocompatibility tests are lengthy and expensive, and no one wants to repeat them. Yet, despite the well-established standards and guidance documents, and specialized laboratories running these tests, sponsors still stumble with sample prep and extraction ratios.
- Consider regulatory guidance carefully and use the pre-sub process to request FDA weigh-in on your biocompatibility plan.
- Assess all elements of your final, finished product for potential biocontact exposure, including delivery systems and accessories, and test representative samples.
- Use appropriate extraction ratios for the biocontact type and duration, and consistently use the same ratio across all relevant biocompatibility tests.
- If there is a valid reason for the ratios to vary, be sure to explain that in an overarching biocompatibility summary report or in the IDE body itself. A solid biocompatibility profile is essential for your IDE and future market authorization.
3. Admirable animal studies
Medical device testing oftentimes requires pre-clinical animal models, another expensive and potentially lengthy endeavor. These models give important insight into usability, effectiveness, and safety, but only if you test the clinically representative version of your product in a well-accepted representative model with sufficient sample size.
- Consider regulatory guidance carefully and use the pre-sub process to get buy-in from FDA on your pre-clinical plan.
- Ensure the device will be used in a clinically representative way (i.e., follow the instructions for use) to generate accurate data and meaningful conclusions. This is especially important when discerning whether adverse events that occurred in the animal are relevant to your device or procedure.
- Consult with appropriate experts to fully understand animal test findings, both the positive and not-so-positive, so you can clearly justify how they apply to the safety and effectiveness of your device. Then, either explain those findings to the FDA, or if necessary, perform the test again.
4. Manageable manufacturing info
The last potentially troublesome category that sponsors struggle with is manufacturing. While a fully scaled, GMP-compliant manufacturing facility is not required at this point in the product development process, it’s still necessary to convince FDA that your manufacturing processes will consistently and reliably yield products that are safe for human use. Meet the following manageable expectations to convince FDA that your device is ready for clinical use:
- Make and test devices that are representative of the clinical product.
- Perform distribution tests and sterilization validation in accordance with recognized standards.
- Ensure your bioburden monitoring occurs frequently enough to account for seasonality and to contribute enough data points for trending analysis.
- Establish an acceptable method to monitor bacterial endotoxin.
5. Full circle feedback
FDA may provide a list of considerations or recommendations appended to the IDE decision letter with this statement: “The recommendations and/or considerations below do not relate to the safety, rights or welfare of study subjects and they do not need to be addressed in order for you to conduct your study.” To avoid any delays associated with feedback,
- Either tell FDA how you have implemented the suggestions or provide a rationale for why they do not apply, or
- If you don’t understand the recommendations, schedule a meeting to discuss the details with FDA.
When you carefully follow IDE content and format recommendations and leverage opportunities for pre-submission discussions with FDA, your IDE submission can get approved within 30 days. Increase the probability of achieving that goal by considering the tips above.
