FDA Guidance Updates Categorization Policy For IDEs, Expedites CMS Coverage

The FDA has issued a guidance that would streamline and clarify the categorization process for investigational device exemptions (IDEs). While the Advanced Medical Technology Association (AdvaMed) is still reviewing the document, a spokesperson commented that updated policies would expedite Centers for Medicare and Medicaid Services (CMS) coverage and increase patient access to new technology and enrollment in FDA-approved clinical trials.
Source: Medical Design Online News - Category: Medical Equipment Source Type: news