You've just designed the greatest medical device of all-time. Now what?

If you've developed a medical device similar to one that's already available on the market, 510(k) submission is the fastest and most economical method to get your new medical device cleared by the U.S. Food and Drug Administration (FDA).

If you're not up-to-speed on the latest pre-submission best practices, the 510(k) process can be a lot to take in all at once.

So, what can your organization do to streamline the entire FDA pre-submission process? Keep reading to find out.

5 Amazing FDA Pre-Submission Tips for Medical Device Manufacturers

As an industry-leading electronic quality management system (eQMS) provider, we have a ton of experience orienting medical device manufacturers toward rapid pre-submission success. In fact, it's one of the reasons why we're continually rated as one of the best QMS software vendors. New call-to-action

Here are some of the very best FDA 510(k) pre-submission tips so that you can achieve and expedite 510(k) readiness.

1. Leverage the 510(k) checklist

To kickstart the pre-submission process, we recommend leveraging the FDA's Acceptance Checklist for Traditional 510(k)s. The information is not intended to serve as a comprehensive review, but the FDA does recommend that the submitting organization include this checklist as part of their application.

This checklist can be used to determine whether the 510(k) meets a minimum threshold of acceptability and should be accepted for review. As a best practice, it is helpful to attach the 510(k) Acceptance Checklist following the Table of Contents. This guidance also includes acceptance checklists for other types of 510(k) submissions, including Abbreviated 510(k) Checklist and Special 510(k) Checklist.

RELATED: A Complete Overview of the FDA 510(k) Process (And How to Shorten It)

2. Prepare responses to FDA questions

Regardless of how thorough your FDA 510(k) submission is, the FDA will almost certainly ask additional questions during the preliminary review process. When the questions start to roll in, we recommend preparing a response team.

Use this as an opportunity to align with team members. What is the FDA asking?

As a best practice, after you've reviewed the FDA's questions as a team, consider scheduling some time with the FDA reviewer. That way, you can better understand the questions being asked and how you might prepare an appropriate response.

3. Match predicate

FDA 510(k) requires organizations to show that the device is substantially equivalent to a predicate device. The more alike the devices are, the easier it will be to achieve 510(k) clearance.

Look for every opportunity to match your device to a predicate if it exists. The best way to do this is to document, line by line, the similarities between your device and a device that has already been approved.

RELATED: Medical Device Quality Assurance and Regulatory Compliance in 2020: What You Should Know

4. Gather information on the predicate

Do your homework. To find an equivalent 510(k) approved product, search for marketing literature, product sheets, and instructions for use. As a best practice, consider purchasing the predicate product. Use this as an opportunity to run comparative analysis and testing. How does your device perform compared to the predicate?

5. Complete testing before submission

Finally, we recommend completing all testing prior to submission. The protocol needs to identify what the goal of the test is, sample size, test method, study endpoint, and pass/fail criteria.

Moreover, the results of the performance test should be clearly documented. Note that animal and clinical testing might not be applicable for your unique 510(k) submission.

RELATED: 4 Reasons Overhauling FDA 510(k) is a Great Move

Make Document Management Easy with Qualio

The single greatest thing you can do to streamline 510(k) pre-submission is to invest in an eQMS. In fact, the implementation of an eQMS can help your medical device manufacturing company stay organized right from the start—helping you move faster.

Unfortunately, failure to document your process can result in application rejection and, in turn, significant delays in the approval process.

Our eQMS was created specifically for medical device manufacturers. As such, you can be sure that you have everything you need to get approved faster.

Is our eQMS right for your unique life science organization?

To find out, we recommend downloading our free guide: 12 Question to Ask Before You Buy an eQMS. In it, you'll learn 12 specific questions to ask as you evaluate your eQMS options.

Here's to making the best decision for your organization!

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Published by Robert Fenton September 29, 2020
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