5 Ways to Ensure your 510k Submission Testing Goes off Without a Hitch

Any engineer who has ever had a hand in the design or manufacture of a medical device understands the enormous pressure that an FDA 510(k) submission brings to a company, large or small. There are countless due dates, action items, and vendors to coordinate with during this high stakes process. And typically, mechanical testing is one of the last stops before submitting to the FDA.

毫不奇怪，有些公司忽略了提前规划测试举措，从而遭遇提交的延误，影响了市场，盈利能力，甚至可能是公司的长期成功。

通过遵循我们的医疗设备测试，避免了这些不期望的是，从事专家的建议，使机械测试510（k）流程最轻松的部分：

1.聘请FDA顾问

我们经常被问到问题，例如，FDA寻找什么？我可以测试和仍然通过的是什么？我应该使用什么谓词？“

虽然这些问题具有优点，我们建议聘请专门制定最坏情况理由和执行510（k）提交的监管顾问。作为独立的测试实验室，元素没有与FDA或任何政府机构的隶属关系。我们的工程师可以建议客户的典型趋势和技术，我们看到所用的技术，但是，我们是测试的专家，而不是510（k）的过程。通过聘请可靠的顾问，您将直接访问有多年的FDA经验和提交过程的人。这个人会知道FDA正在寻找什么，可以帮助您提前计划以避免令人不快的惊喜。

2. Feasibility Testing: Early and Often

大多数人不会跳进游泳池，而不是先粘在脚趾中来测试水域。对于为FDA 510（k）提交而设计的设备也是如此。在最终确定设计或概念之前，经过多轮可行性测试至关重要，以确保该装置具有足够的强度和疲劳性能。可行性测试对于通过进行微小的变化和测试这些变化的效果，可用于优化已经充分的设计。

通过在可行性测试中投入少量前线，您可以节省失败的官方提交测试的可能性，这将导致灾难性的挫折。

3.了解你的谓词

谓词设备是我们从植入设计师和制造商收到的大多数问题的主题。“我在哪里可以找到谓词数据？”“我如何获得谓词？”“我真的需要谓词吗？”

答案是,是的,FDA总是需要一个小鬼lant to be compared to a predicate device or predicate data. Therefore, predicate devices are one of the most important considerations for 510(k) submission, and should not be an afterthought. Whether you locate previously published predicate data or you procure predicate devices for side-by-side testing, make certain that the data or devices are acquired well ahead of schedule for testing. The predicate devices set the acceptance criteria for your testing projects and give a benchmark to measure against. Often times, multiple predicates are used.

4.早期写协议

Test protocols are critical for 510(k) submissions. Often, clients believe that since they are testing to a known ASTM standard, that a protocol isn’t necessary. In other cases, clients assume that the test lab includes test protocols that are sufficient. Neither of these cases is true.

协议通常包括比测试方法的更多信息，例如理由和最坏情况大小的理由，以及有关指示，使用，图纸，偏差等的信息。可以使用彻底的协议，并将“丢弃”进入510（k）提交，并提供了解释理由的巨大结构。由于协议草案所需的时间长度，早期开始这个过程是至关重要的。请务必解释您的协议中的任何和所有偏差，以及您的FDA顾问可以帮助您的其他所需文档（参见＃1）。

虽然测试实验室可以帮助您开发与协议的测试相关部分，但通常实验室对构建全面协议所需的所有信息并不遗证。此外，协议开发通常被认为是咨询服务，除了实际测试成本之外还被账单。元素经常帮助客户端创建协议。我们的客户更频繁地拥有已经开发的协议。在这些情况下，我们的团队将在项目开始之前审查该协议，并且通常能够提供节省时间和金钱的建设性反馈。

5. Be Generous with your Timeline

Pressure comes from many angles during the 510(k) submission process. Owners and investors, in particular, often press for extremely tight timelines for completing a submission. While this is understandable, designers and manufacturers should be careful to ensure that their proposed timelines are realistic and achievable. Only allowing three weeks for seven weeks of testing, for instance, is a surefire way to miss your submission deadline. Check with your testing partner ahead of time to get a feel for how much time will be needed to complete testing and to ensure availability. Element enables clients to schedule test frames months in advance, which eliminates the headache caused by having to wait in a lab’s queue when samples are finally available.

在许多情况下，制造商遇到了其他供应商造成的延误。因此，公司往往试图在测试阶段“弥补时间”。在这些情况下，整个行业通常可以提供加快的选择，但务必在开发时间线时递增额外的成本与结果更快。并与您的期望变得逼真。机械测试太重要了，无法随意地匆忙。