FDA Registration Guide for Small Medical Device Businesses
A Practical, Step-by-Step Guide for First-Time FDA Registration
Are you starting a small medical device business and feeling overwhelmed by FDA registration requirements?
This FDA Registration Guide was created specifically for small medical device businesses, startups, and first-time manufacturers who need a clear, practical, and organized way to complete FDA registration and listing — without digging through endless regulations.
This is not legal advice or a generic overview.
It’s a straightforward, actionable guide designed to help you understand what to do, when to do it, and what information you need.
This spreadsheet is designed to organize and simplify your process of appraising clinical literature as part of your post-market surveillance activities or Clinical Evaluation Reports (CERs). It allows you to systematically capture key data points such as study design, patient population, outcomes, and relevance to your device. By structuring and standardizing this information, the spreadsheet helps ensure thorough and consistent evaluations, making it easier to identify trends, gaps, and risks.