Your regulatory strategy determines whether your 510(k) submission clears the FDA or dies on the vine. It is the deciding factor in how long clearance takes: from 90 days to over six months. Lost months mean lost revenue and re-tasking resources that could be spent on other revenue-generating activities.
Every month that clearance is delayed is a month of lost sales.
The solution is to deploy a set of tactics designed to minimize questions from the FDA and improve time to clearance. Below, we will cover five such regulatory tactics.
What are 510(k) Submissions?
A 510(k) Submission is a premarket submission made to the Food and Drug Agency (FDA) that demonstrates that the device you are marketing is safe, effective, and substantially equivalent to another legally marketed device in the United States.
"Substantially equivalent” refers to a new device that is as safe and effective as a predicate device. A device can be substantially equivalent to a predicate if it has similar intended use as the predicate and shares similar technological features as the predicate. It could also have different technological characteristics as the predicate, as long as the differences have no effect on safety and effectiveness.
Where 510(k) Submissions Fail
There are two major parts to the submission process: the acceptance review and the substantive review. Essentially, acceptance review is all about making sure the submission follows the right formatting and that required sections are included. The acceptance review seeks to determine whether basic requirements such as formatting have been met. If it passes through the review, it advances to the substantive review. This review determines whether there is substantial equivalence.
In general, the substantive review is more difficult to clear. There are countless issues the FDA may raise regarding claims of substantial equivalence.
While there are always risks that your 510(k) clearance can be significantly delayed, it is possible to have a relatively smooth and successful submission process.
The Five 510(k) Regulatory Tactics
- Start with a Pre-submission Meeting Request
Before submitting a 510(k) to FDA, consider getting non-binding feedback through the pre-submission program. It is an optional step - an opportunity to gain insights from the FDA and obtain important feedback. These meetings can yield valuable preemptive insight regarding FDA expectations. They can be face-to-face or teleconference interactions.
- Review the RTA Checklist
You should always refer to the FDA's Refuse To Accept (RTA) checklist to gain insights on the criteria that the FDA uses to assess whether a 510(k) meets the minimum thresholds of acceptability for a substantive review. A review of the RTA checklist enables you to better understand the requirements to prepare the types of information the FDA needs. Including your completed RTA checklist in your submission aids your FDA reviewer during the acceptance review period.
Use the checklist as a reference to make sure your submission will pass the acceptance review.
- Use the Substantial Equivalence Flow Chart
The best way to ensure substantial equivalence exists in your 510(k) submission is to use the same decision-making tool that the FDA uses.
One critical decision-making tool that the FDA developed is the substantial equivalence flow chart. The chart provides industry and FDA staff guidance regarding the prevailing review practices for premarket notification 510(k) submissions. It seeks to identify, define, and explain each of the FDA's essential decision points to evaluate substantial equivalence.
The tool describes in detail the regulatory framework, policies, and practices crucial to the FDA's 510(k) review. The Substantial Equivalence Flow Chart comprises the following questions:
- Question1: Is the predicate device legally marketed? If the answer is yes, a review of all labeling is done to ensure consistency with Instructions for Use (IFU) statements.
- Question 2: Do the devices have the same intended use? If the answer is yes, review the design, materials, energy source, and other features of the devices
- Question 3: Do the devices have the same technological characteristics? If the answer is yes, the device is declared as Substantially Equivalent.
- Cite Reference Devices
A reference device is a legally marketed device used to provide scientific or technical information to help address the question of a new medical device's safety and effectiveness before it is introduced into the market. It is used in addition to the predicate when companies wish to demonstrate a process or method has been used before.
Reference devices should not be confused with split predicates, a concept the FDA does not always deem acceptable.
- Consider 510(k)Stacking
If your ideal 510(k) includes a broad range of indications, it may be better to file a first 510(k) with limited indications for use. Later on, you can add indications for use in the subsequent 510(k)s, which use the first 510(k) as a predicate device.
Focus on the indication(s) that address the largest possible segment of your desired market. Extraneous claims may require additional time to obtain clearance.
Many regulatory tactics exist outside of the five discussed above. Beyond these five tactics that are specific to 510(k) submissions, you should also follow best practices in regulatory writing. High-quality submission documents help you avoid expensive delays and rejections that ultimately lead to extra costs and compliance risks.
Interesting in learning more about how to improve your 510(k) clearance results? Contact us for a no-obligation consultation offered by Medpoint.