钱柜平台副总裁兼医疗器械监管负责人, 劳里克拉克, shares hints and tips on how to work more effectively with the FDA over medical device submissions.
When medical device 公司 make an application or submission to the Food and Drug Administration (FDA) a lot of thought goes into how to present the best case. 然而, it’s easy to get so caught up in the big picture of the device that smaller details get overlooked. 这可能会导致无法预见的问题，从而阻碍进展.
Whether you’re working on Investigational Device Exemption (IDE), 上市前的批准(PMA), Premarket Notification (510(k)) or any of the other FDA applications, 注意细节是很重要的. Misuse of terminology or an erroneous decimal point can introduce uncertainty and sink an otherwise watertight submission. The same is true of meetings with the FDA; you generally have one hour to make your case, so it’s important to ensure presentations and demonstrations are as seamless as possible.
Ask the following questions before you hit send on an FDA submission or attend a meeting.
Clarity and consistency should be the defining features of written FDA submissions. 保持结构简单. As my own mentor said: "Tell them what you’re going to 告诉他们, 告诉他们, 告诉他们你告诉他们的". 我总是鼓励客户和同事也这样做.
当钱柜手机版谈到重复这个话题时, FDA submissions are not the place to show off your impressive vocabulary, 特别是当它带来歧义的时候. It’s far better to use the same word repeatedly when describing a device’s structure, 函数, or intended use than to use synonyms which may confuse matters. A busy reviewer is reading the submission, not your high school English teacher.
让FDA审查员更容易找到他们需要的东西. 保持文档的重点, use headings and hyperlinks between sections if it might be necessary to 交叉-reference different sets of information.
最后，在提交之前一定要留出时间进行校对. Ideally, ask someone who hasn’t been closely involved to give the document a final check. 让他们强调任何不一致的地方, 或者意思不清楚的地方, 以及修复打字错误.
If you have the chance to meet with the FDA in person, make sure you maximize the opportunity. 与文档一样，清晰和重点是关键. 通常你只有一个小时的时间走很多路, so don’t take up valuable minutes with 公司 history or credentials. 直奔主题:解释你的设备有什么功能, 概述其医学应用, 提供安全有效的证据.
The end goal is for the FDA to understand your device and approve its use. So, think about what information they’ll need in order to do that, and convey it clearly.
It’s very tempting to take a physical device to face-to-face meetings to show how it works. 但在这里你要小心. 现场演示中会出现很多问题, 破坏设备本身和你的可信度. A more effective approach could be to create a short video introducing the device and showing it in action.
Before the meeting, have a final run-through of the presentation and any supporting videos. 如果可能的话, set up a dress rehearsal – this is a great way to identify any issues that might otherwise trip you up on the day.
It’s always helpful to have an external perspective on FDA submissions and presentations.
Smaller medical device 公司 and start-ups might benefit from a seasoned professional to guide them through the process, 特别是如果这是他们第一次与中情局会面. Larger 公司 may have mastered the art of successful meetings with the Agency, but they can still benefit from an impartial review and constructive advice.
It can also be useful to have someone come on board to ‘play the bad guy’, 挑战和质疑提交. This can reveal problem areas or inconsistencies which may need further work or clarification. Choosing a partner with experience in FDA submissions and meetings can make a significant difference to the outcome. Involving them from an early stage in the process makes it more likely that issues are identified when t在这里’s still plenty of time to rectify them.
When you’re compiling an FDA submission or preparing for a meeting, 感觉就像有很多东西危在旦夕. The process is resource-intensive and often involves input from several people or teams. It’s not unusual to find that changes and additions are being made right up to the last minute, which increases the risk of mistakes or inconsistencies being introduced. 如果你一开始就计划好了, 并安排好内部里程碑, it helps ensure that adequate time is allowed for final checking and rehearsals.
不过, 即使是最好的, most carefully prepared submissions and presentations are still likely to provoke questions from the FDA. Don’t be discouraged by this – it is a normal part of the process. Gaining approval for a medical device isn’t easy, and nor should it be. Review the questions, take stock, and think about how to resolve them effectively. The important thing is to keep the process moving towards obtaining FDA clearance or approval.
劳里克拉克 previously worked as FDA partner at several large law firms in the US. 在次数, her knowledge of regulatory programs that affect medical devices enables her to offer expert counsel to 公司 that are developing new device concepts.
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