Practical FDA Strategies to Avoid Stunning Disaster
Wed, Oct 17
11:15 a.m. New York time
Remember: You’ll receive the slides and video replay even if you can’t attend the live event.
There are three sure ways that result in FDA submission disaster. First, you identify the wrong regulatory pathway (e.g., 510(k) instead of De Novo). Second, you spend your money on the wrong testing. Third, when the FDA offers advice, you ignore it. Many De Novo applicants make at least one of these mistakes.
Imagine you just invented a fantastic, elegant, prototype device to treat patients. The device is a non-significant risk device, so you obtain IRB approval and perform limited clinical testing. Preliminary results are overwhelming, and you immediately begin benchtop testing for an eventual 510(k) submission. Four months later, your benchtop testing is completed and you submit your 510(k). Unfortunately, the FDA identified your device as non-substantially equivalent. The FDA advises your firm that a De Novo Request will be required along with human clinical data. The FDA also recommends that you submit a draft clinical study protocol to the FDA as part of a pre-submission request prior to conducting the study.
Since you already have a clinical study protocol approved by an IRB, you continue the study instead of waiting for FDA feedback in a pre-submission meeting. Eventually, you submit a pre-submission request to the FDA, but at this point you have already collected two months of data from nearly 100 clinical subjects. The FDA provides email feedback that they have safety concerns that require you to modify your clinical study significantly. Specifically, the FDA wants you to have a control group using a sham device, and the FDA wants you to gather additional clinical endpoints to address their safety concerns regarding the long-term use of your device.
What should you do now?
Fortunately, you are still developing your medical device, and you haven’t made these mistakes yet. If you are developing a medical device, I always recommend verifying two things with the FDA before you start any testing: 1) verify that you identified the correct regulatory pathway, and 2) verify that your testing plan meets FDA requirements for a submission. If your device requires a De Novo Request with clinical performance data, there are several practical FDA strategies you should consider prior to spending more money.
On October 17 @ Noon EDT, Rob Packard will present a guest webinar on De Novo submissions hosted by Joe Hage. Rob will share some of the lessons learned from recent 510(k) and De Novo submissions, and he’ll offer practical strategies that will help you achieve earlier positive cash flow and reduce your testing costs.
Bonus! Additional information on this topic, immediately available after your free registration.
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