The majority of medical device companies that submit US Food and Drug Administration (FDA) pre-market submissions, including 510(k)s and pre-market approval (PMA) applications, receive deficiency letters requesting additional information in order for the FDA submission review process can be a challenging, time-consuming, labour-intensive and resource-intensive.
NSF International provides medical device consulting services throughout the FDA pre-market review process, including regulatory strategy, support with submission issues meetings, and the development of deficiency responses.
This white paper identifies the do's and don'ts as a starting point to help navigate the medical device submission process more effectively and efficiently.
Download this free white paper to find out more.
Download to find out more.