In Depth: US FDA Medical Device Registration and Compliance

Information current as of January 2017.

The US market represents more than 40% of the global market for medical devices. Yet for many manufacturers, the process of obtaining clearance from the US FDA can be daunting. In this seven part slidecast we will demystify the FDA device clearance process, breaking it down into understandable steps and explaining each one. Once you begin the series you may skip to the next section at any time.

Here is what we will cover:

  1. An overview of the US market and regulatory framework [runtime = 3:58]
  2. The steps involved in classifying your medical device [runtime = 3:56]
  3. Quality Management System requirements [runtime = 3:25]
  4. Product testing and clinical data requirements [runtime = 3:08]
  5. Registration dossier preparation [runtime = 5:12]
  6. In-country representation for companies with no US office [runtime = 2:08]
  7. Device listing on the FDA website and maintenance [runtime = 2:39]