Living Innovation Blog
A blog about important topics for medical device and healthcare innovators.
You and the FDA: Medical Device Applications for Pre-Submission Review
In our latest article, Ximedica’s Regulatory and Human Research Affairs Lead, Kimberly Waller, Ph.D., explains how FDA pre-submissions minimize difficult, time-consuming questions from the FDA after submitting your marketing application.
Scheduling pre-subs with the FDA early in the development of your product and regulatory plan will:
- Provide answers to all of your regulatory questions prior to design
- Reduce the burden on your reviewer
- Eliminate the need for lengthy rewrites
To read the full article, please visit: http://www.ximedica.com/images/pdfs/Ximedica_Article_You_And_FDA_%281%29.pdf