5 Ways to Ensure your 510k Submission 测试 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, 大或小. 有无数的截止日期, 行动项目, and vendors to coordinate with during this high-stakes process. 通常, 机械测试 是提交给FDA的最后一站吗.

不足为奇的是, 一些公司忽略了计划他们的测试计划, 因此, 提交时遇到延误, 哪些影响上市时间, 盈利能力, 甚至可能影响公司的长期成功.

Avoid these undesirables by following our medical device testing Engaged Expert's advice to make 机械测试 the most effortless part of your 510(k) process:

1. 聘请FDA顾问

We are often asked questions such as, “What does the FDA look for? 我能通过测试的最低限度是多少? 我该用什么谓词呢?”

虽然这些问题有其可取之处, we recommend hiring a regulatory consultant who specializes in developing worst-case rationales and executing 510(k) submissions. 作为独立的检测实验室, im体育APP has no affiliation with the FDA or any government agency. Our engineers can advise clients of typical trends and techniques we see employed, 然而, 我们是测试方面的专家, 不是510(k)程序. 通过雇佣一个可靠的顾问, you will have direct access to someone with years of experience with the FDA and the submission process. This person will know what the FDA is looking for and can help you plan to avoid unpleasant surprises.

2. 可行性测试:尽早并经常进行

Most people wouldn’t jump into a swimming pool without sticking a toe in first to test the waters. The same should be true for devices that are being designed for FDA 510(k) submission. 在最终确定设计或概念之前, it is critical to undergo multiple rounds of feasibility testing to ensure that the device has sufficient strength and fatigue properties. Feasibility testing is also useful for optimizing already sufficient designs by making small changes and testing the effect of those changes.

通过前期投入少量资金进行可行性测试, you are saving the potential for failing the official submission tests, 这将导致灾难性的挫折.

3. 了解你的谓语

Predicate devices are the subject of most questions we receive from implant designers and manufacturers. “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, the FDA always requires an implant to be compared to a predicate device or predicate data. 因此, predicate devices are one of the most important considerations for 510(k) submission, 不应该是事后才想到的. 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. 通常，会使用多个谓词. 

4. 尽早编写协议

测试协议对于510(k)提交至关重要. 经常, clients believe that since they are testing to a known ASTM standard, 协议是没有必要的. In other cases, clients assume that the test lab includes sufficient test protocols. 这两种情况都不对.

Protocols typically include much more information than the test methodology, 比如最坏情况的基本原理和理由, 以及关于适应症的信息, 使用, 图纸, 偏差, 等. Thorough protocols can be used and “dropped” into the 510(k) submissions, and give a great structure for an explanation of the rationale. Due to the length of time required to draft protocols, it’s critical to begin this process early. 一定要解释协议中的任何偏差, along with other required documentation that your FDA consultant can assist you with (see #1).

While test labs can assist you with developing the testing-related portions of your protocol, usually labs are not privy to all the information required to build a comprehensive protocol. 除了, protocol development is typically considered a consulting service, 除了实际的测试费用外，还有哪些费用. im体育APP经常帮助客户端创建协议. Even more frequently, our clients have protocols already developed. 在这些情况下, our team will review the protocols before a project begins and often can provide constructive feedback that saves time and money. 

5. 慷慨地安排你的时间表

Pressure comes from many angles during the 510(k) submission process. 业主及投资者, 特别是, often press for extremely tight timelines for completing a submission. 这是可以理解的, designers and manufacturers should be careful to ensure that their proposed timelines are realistic and achievable. 七周的测试只允许三周, 例如, 是否一定会错过提交截止日期. 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. im体育APP 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.

In many cases, manufacturers run into delays caused by other vendors. Because of this, companies often attempt to “make up the time” at the testing stage. 在这些情况下, expedited options are generally available throughout the industry but are sure to weigh the additional costs vs. the quicker turnaround of results when developing your timeline. 对你的期望要现实一些. Mechanical testing is too important of a process to rush through haphazardly.

im体育APP如何提供帮助? 

im体育APP is FDA registered and ISO/IEC 17025 accredited to provide an extensive range of 510 (k)测试 并提供咨询服务，帮助您获得市场许可. 我们的监管团队将发挥作用 closely with you to ensure appropriate tests are selected for your 510(k) submission. 

For more information about our FDA 510 (k)测试 and medical device consulting services or to request a quote, 立即im体育APP.