Your business, Your passion, Our seasoned expertise
Your regulatory strategy will determine your business success
FDA has different ways to bring a medical device to market that depend on its intended use, technology and novelty :
Investigational Device Exemption
Premarket Approval Applications
The Pre-Submission Request is a means of asking questions to FDA and can be essential in determining which 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)s
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.