Question: Why should device companies take advantage of the FDA pre-submission process?
Answer: Ensuring that new orthopedic devices are compliant with FDA regulations can be an expensive and lengthy process. Few things are more frustrating than spending an exorbitant amount of time and money conducting studies or clinical trials before submitting a 510(k), only to find out FDA recommends other data than that used in your research and development. The truth of the matter is that it’s better to confirm with FDA the details of your submission in order to maximize efficiency and minimize risk. FDA’s free pre-submission program is a great way to accomplish this.
Essentially, the purpose of the pre-submission program is to negotiate a regulatory plan with FDA. Companies should consider the pre-submission process for an Investigational Device Exemption, Premarket Approval and even a 510(k) for a major implant product that requires an expensive test. Almost no 510(k)s make it through FDA’s review process without some kind of deficiency or request for more information. Utilizing the pre-submission process provides an opportunity to address potential concerns early in the process, and it can significantly reduce the risk of delays once a 510(k) is under review.
It’s important to understand that while FDA will provide expertise to help determine the precise plan for a product, it will not design or customize a plan for you. Rather, companies must provide FDA with a high-level view of their device—its predicate, what it’s made of, clinical indications for use, test plans—and propose questions for feedback.
When a company participates in the pre-submission process, FDA provides written feedback and, when requested, participates in a meeting or teleconference with the applicant. FDA responds to all of the questions posed by the applicant in writing within 70 days of the submission. In just two and a half months, companies can de-risk their regulatory pathway and begin conducting tests with confidence.
There are several examples as to why companies may want to consider taking advantage of the pre-submission program.
When it comes to more costly and time-consuming studies, the pre-submission process can reduce the risk of wasting resources. For example, knee-wear tests can take a long time to complete. Biocompatibility, extractables and leachables tests are very expensive and are required more often than not, even on something as common as a hip implant. For these reasons and more, companies should perform tests to FDA’s satisfaction the first time rather than having to repeat them. Test labs can be backed up for several weeks, sometimes months, and no company wants to waste time or money getting products ready to market.
If a company is working on a novel device, whether in material or design, it’s especially useful to engage FDA. Companies must propose exactly how they will manage technological differences in a device compared to predicate devices, and it will take longer if the predicate device is unclear. It is better to do this in the pre-submission process than the 510(k).
New companies may find the pre-submission program to be beneficial. The pre-submission process is a good way to introduce yourself and your company to FDA and gain further insight not outlined in guidance documents. It also provides an opportunity to get to the know the people who will be reviewing your future 510(k)s. Chances are at least one person who reviews your pre-submission paperwork will also review the 510(k).
Taking advantage of FDA’s pre-submission program offers several benefits. By taking early steps to ensure that studies and clinical trials are performed appropriately, the process will run more smoothly and new products can be in the hands (and knees and hips) of eager patients most efficiently.
Robert A. Poggie, Ph.D., is President of BioVera, Inc., a consulting company specializing in FDA and Health Canada regulatory strategy and execution, with expertise in biomaterials, applied research and device testing. His previous employers include Smith & Nephew, Implex, Zimmer and Pipeline Orthopaedics.