Part II will drill down into how FDA is regulating advertising and promotion for 510(k) devices and will cover in-depth FDA’s General/Specific Use guidance and how it is actually being interpreted today in 510(k) submission discussions and enforcement matters. We will discuss what options management has for marketing a device with a broad intended use statement when the market is in more specific indications/uses, including addressing the risk or what happens if FDA later disagrees with the company’s position on what is on or off-label. We will briefly discuss the “begin-with-the-end-in-mind” strategies that can be employed when going to FDA to seek that initial clearance for a device. We will discuss claims construction techniques and their impact on device design, supportive clinical trial design, reimbursement claims and the claims that can be obtained and claims that may take the device into a de novo or PMA pathway. We will discuss what FDA considers the “intended use” versus “indications” versus the “label.” For example, can the company promote claims about clinical, animal or bench data that was submitted to FDA in its submission? Can the company use information/language in the cleared “Device Description” “Mechanism of Action” “Summary Statement” promotionally? Importantly, we will cover specific cases and Warning Letters as examples of how FDA is viewing this topic today.
Marketing your Medical Device in the new FDA/OIG Enforcement Environment Part 2
- On July 8, 2014 at 11:07AM
- Categorized in Conferences