You want to submit a 510(k) to FDA for your product, but you know a Not Substantially Equivalent (NSE) letter will set back your program with further market entry delays, additional fees paid to FDA, and additional expenditure for further tests.
We have filed over 50 510(k)s for our clients, without a NSE finding by FDA. By using Vision28 you will be more likely to obtain clearance to market your device with minimal review time.
A FDA reviewer may come to a different conclusion than you did after reviewing your 510k even though the data shows equivalence, because the “story” in the 510(k) did not convince the reviewer of substantial equivalence.
With over 20 years’ experience writing successful submissions, we know a successfully written 510(k) presents a coherent and consistent Substantial Equivalence argument for the predicate device throughout the entire 510(k). We will provide the reviewer a 510(k) “story” that forms a clear, logical path to follow when arriving at the conclusion your device is Substantially Equivalent to the selected predicate device.
Inexperienced 510(k) writers may become confused with complex technologies, and may fail to make compelling arguments for substantial equivalence, or worse, may misrepresent your product.
Our 510(k)s include a wide range of complexity in products: reprocessed single use devices, simple mechanical devices, complex motor driven electro-mechanical systems, algorithm driven software imaging systems that 3D-print medical devices and In Vivo Diagnostic Kits. We make sure you are collecting the right data as referenced by the correct FDA guidance documents, and we make sure you are developing the product according to recognized standards. We then represent your product compared to the predicate device, and construct the Substantially Equivalent 510(k) “Story.”
FDA 510(k) Reviewers have exposure to all medical devices like yours, and come to expect specific data, data analysis and conclusions as they review competitors’ 510(k)s. Will your 510(k) measure up?
By making sure we are collecting the right data, that is, high quality, necessary data, your business will not spend time and money developing data that will not be adequate or necessary to prove Substantial Equivalence.
Your product is more unique than your competitors, and you are concerned you may not have the right predicate device for your 510k.
Products we have obtained 510(k) clearance have ranged from very obvious predicate devices, to multiple predicates with which to demonstrate Substantial Equivalence. By finding the most appropriate predicates to base your initial 510(k) submission, you build the foundation for additional 510(k)s as you expand your product offering.
Your products unique, and you are not sure 510(k) is the right way to go. You face expensive clinical studies and laboratory studies, and you are not sure FDA will agree with your approach.
In addition to our 20 years’ experience writing successful submissions, we have conducted many pre-submission meetings with FDA and our clients to assure the path you are on will gather the data the FDA requires to find substantial equivalence. By engaging FDA as part of a pre-submission process, you can be certain the money you spend for clinical and laboratory studies are necessary, and will be acceptable to the FDA. We can advise you if a pre-submission meeting is right for you, and we can arrange the meeting and help you prepare for the meeting with FDA.
The Pre-Submission Request is a means of asking questions to FDA and can be essential in determining which regulatory path is best for you.
You may prevent
- Thousands of dollars in fees
- Loss of sales due to product launch delay
You may gain
- Confidence of your financial backers
- Confidence in your business plan
- Confidence in your time to market
- A clear understanding of what FDA expects
Types of things you may want to ask about
- Critical or resource-intensive bench tests or animal or clinical studies
- Adequacy of your proposed clinical studies
- Do you need clinical studies
- Does your 510(k) raise unusual issues
- Do you have the right predicates to compare to in your 510(k) submission
We can help you decide which approach is best for your particular situation; complete the requisite paperwork for the request; review, edit or author the substantive request; and attend meetings or telecoms with you.
Premarket Notification: 510(k)
There are three types of Premarket Notification 510(k)s that may be submitted to FDA: Traditional, Special, and Abbreviated.
We can help you decide which approach is right for you, and then our seasoned professionals will prepare your submission and submit it to FDA.
Traditional 510(k)s may be used for a new device or for a modification to a previously cleared device.
In this submission all test data is included in the submission and the FDA strives to complete their evaluation in 90 days.
Special 510(k)s may be submitted for a modification to a device that already has a 510(k). If a new 510(k) is needed per the guidance for new 510(k) requirements, and there is no modification to the intended use or the underlying technology of the device, then summary information from the design control process may serve as the basis for submission.
FDA strives to clear Special 510(k)s within 30 days, rather than the 90 days required for a Traditional 510(k) submission.
The Abbreviated 510(k) relies on the use of guidance documents, special controls, and recognized standards. An Abbreviated 510(k) submission must include all of the elements of a traditional 510(k). However, in an Abbreviated 510(k) submission manufacturers provide summary reports on the use of guidance documents, special controls, or declarations of conformity to recognized standards, instead of test data, to expedite the review of a submission.
We can provide you a Preliminary Regulatory Assessment which will evaluate your device against FDA regulations to determine what categorization, class, predicates and life-cycle characteristics may apply to your device.
Using this information, we will determine a Regulatory Strategy which includes what submission strategy would be best for your situation, and what special controls, testing, guidance or recognized standards may apply.