Pathmaker FDA Law has over 30 years of experience in guiding medical device and pharmaceutical businesses in getting their products approved or cleared. We understand what regulatory bodies require and what path is right for you to get your drug or device to market.
Contact us to guide your business to “yes”.
We’ll guide you through the process and help craft the 510(k) submission to ensure that it meets the substantial equivalence criteria and is approved on its first submission.
Our team will help you put together your pre-market approval to demonstrate that your device is safe and effective.
De Novo Submissions
No predicate device? We’ll help guide you through the process when this is the case to get your device to market.
MDD and MDR
Need help making your device MDR compliant? We can help create your plan to gather clinical data to continue to market in Europe.
Not sure what class your device falls into? Pathmaker will help craft your device description.
International Medical Device Submissions