Changes in FDA Submission Review Process.
It comes as no surprise to most medical device manufacturers to hear that the FDA has significantly increased the level of detail required for premarket notifications (510(k)s) and premarket approvals (PMAs) over the past year. It is clear that the submission review process includes more plentiful and more detailed questions than ever before.
Are you struggling with how to respond to FDA questions or concerned about how much information is needed for your next submission? CCS can help. We have supported over a dozen submissions so far this year and we have also participated in numerous conference calls with the FDA and several (preIDE) meetings at FDA headquarters.
Avoid unnecessary delays by letting us streamline your next submission. Our experience covers a wide range of devices, let us help with yours.