The FDA Medical Device Approval Timeline: How Long Does it Take?
The U.S. Food and Drug Administration (FDA) regulates everything produced by drug and medical device companies. The FDA approval process is designed to ensure that every product on the market meets certain standards of safety and effectiveness. However, it can be confusing for anyone trying to navigate it independently. Here’s what you need to know about the FDA medical device approval timeline â€” plus some tips on navigating the regulatory process with as few hurdles as possible.