510(k), IDE, PMA, HDE Submission Drafting

Hack & Associates authors 510(k)s, IDEs, HDEs, HUDs, PMAs and pre- submissions.  We ensure that your submission is comprehensive, complete, and in full compliance with FDA’s current submission acceptance guidance.

Using our engineering expertise, we accurately respond to science based deficiency letters specifically, those challenging substantial equivalence testing, biocompatibility, and packaging.

Furthermore, H&A provides 510(k) drafting seminars, deficiency reading and responding seminars, and strategies as to how to use literature data to best supplement 510(k)s and IDEs.

In addition, H&A uses medical writers and physicians to help select literature reviews and to review clinical data for submissions.

We can also help draft and review any communications with the FDA including emails, inquiries FDA 483 responses and Warning Letter responses.