The U.S. Food and Drug Administration is perhaps the most stringent regulatory body when it comes to accepting clinical data in support of a medical device or IVD submission. That’s the bad news. The good news is that if you meet FDA’s rigorous criteria for clinical study design, your data can most likely be used to support your submissions to other regulatory bodies around the world. Running a clinical study requires a huge investment of time, effort and cost, and finding out that FDA has rejected your company’s 510(k) or PMA application because they found fault with the clinical study design can be devastating. Therefore, FDA offers companies the option of submitting their clinical study protocols to the FDA for a pre-IDE review. While it is not a guarantee, companies who do submit their clinical study protocols to FDA for a pre-IDE review and subsequently adequately address the review issues greatly increase the likelihood that the data from the clinical study submitted in the device application will meet FDA’s criteria, assuming the study outcome is successful, of course. Regulatory Insight has extensive experience writing and submitting pre-IDEs to the FDA. In fact, we almost always insist on submitting a pre-IDE for our clients’ study protocols, especially for novel devices or indications for use. We simply believe that without the benefit of a pre-IDE review, the heightened potential risk of FDA finding fault with the study design after the fact is too great to advise our subjects otherwise. We know precisely what questions to ask during the pre-IDE process to assure that all the bases are covered. Following the pre-IDE review, we will work with the FDA in making any necessary modifications to the clinical study protocol to assure that all of the issues raised through the review are satisfactorily addressed.