When it is time to get your product to market, there are a number of options available. We work closely with clients to develop a submission strategy for optimal success based on their needs. Reglera has a successful history of submissions and average 510(k) clearance times are less than ninety days.
Some of the submissions we have extensive experience with include:
510(k)
A pre-market submission to demonstrate substantial equivalency to a product currently on the market.
513(g)
A formal request for classification that can be made prior to a 510(k) submission.
De Novo
Classification intended for lower risk devices to get them to market where there is no predicate device.
Pre-IDE
In order to facilitate the initiation of clinical trials under the IDE regulation, the FDA encourages sponsors to begin communicating with the ODE reviewing division prior to the submission of the original IDE application. This communication may take the form of a "Pre-IDE" meeting and/or a "Pre IDE" submission.
IDE
Clinical trials using unapproved medical devices on human subjects are performed under an Investigational Device Exemption (IDE). Clinical studies with devices of significant risk must be approved by FDA and by an Institutional Review Board (IRB) before the study can begin.
Pre-Market Approval (PMA)
Submissions for Class III devices (high risk) or devices found not substantially equivalent to Class I and II predicates through the 510(k) process.
Route To Market (Device)
The FDA has numerous requirements that must be completed before products can be distributed in the United States. Each approval depends on the type of device and risk to public safety. Our Route To Market Service is a low cost approach to evaluating all possible approval options and helping you decide which is most appropriate for your business.
Our experienced team learns about your product, the market it serves and any predicate devices and technology. We will have discussions with FDA as necessary and ensure that you begin your approval process in the appropriate manner so you do not have to change your strategy midstream.