A Critical Guidance Has Been Issued – “Refuse to Accept Policy for 510(k)s”

Our very own Teresa Gorecki took to LinkedIn earlier this afternoon to announce…

A critical Guidance has been issued by FDA; the new Guidance, “Refuse to “Accept Policy for 510(k)s”, is now available on fda.gov.

This is an important Guidance document for all firms intending to file 510(k) s for products in their pipelines. Failure to meet these criteria will lead to a “refusal to accept” for the firm’s submission. This results in an increase in overall cycle time to final approval of new devices; once the submission is refused by FDA, the “time clock” begins again for all revised and resubmitted 510(k)s.

This slows approval of new devices; patients must wait for important new devices and technologies and firms must revise their launch calendars and financial projections accordingly. Patients are waiting. It is worth the effort to get the submission “ right the first time”. An overused “slogan” but now an FDA requirement for 510(k) submissions.

One industry expert was quick to reply, “Thanks for sharing – another example of how #FDA is raising the bar on #medicaldevices”