Medical Device Submissions

We'll help you clear your medical devices by FDA prior to market entry.

 

Medical devices must be cleared by FDA prior to market entry.  Even before the product dossier is submitted to FDA it is important to determine the regulatory status and classification of the device. These criteria will determine what information must be submitted to FDA. 

The next step is to determine whether the product is substantially equivalent to a cleared, marketed medical device. If so, the route will be a 510(k) submission; otherwise a premarket application (PMA) is required. In both cases, there must be data to show that the device is safe and effective.

We encourage medical device companies to consider Medicare and third party reimbursement codes early in the development process to ensure that their product will be covered by insurance and therefore actually prescribed and used.  It is also helpful to determine whether the company qualifies as a ‘small business’ in order to save on the filing fees that must be paid to FDA. 

View Drug & Device resources.

Compliance Simplified

We'll help you cut through the red tape.