US FDA Updates Device Accessory Guidance
Executive Summary
The document explains how to request classifications for new or already approved medical device accessories, independently from their parent devices. It replaces a final guidance from January 2017.
You may also be interested in...
Eight Device Accessories Could Break Free To Class I
The US FDA is floating eight categories of device accessories for low-risk, class I designation as part of its shift to addressing classification of accessories separately from "parent" devices. It also clarifies its approach to orthopedic instruments.
MDUFA IV (And More) Is Law: Trump Signs A Health-Care Bill
President Trump's eleventh-hour signature on the FDA Reauthorization Act puts into play about $1bn in device user-fee collections from industry through FY 2022, new US FDA performance goals and a range of device process enhancements and reforms supported by industry.
FDA Provides Accessories Guidance, But May Be 'Missed' Opportunity
While the US agency's final guidance on medical device accessories provides sponsors assurance the agency could be more lenient in classifying their products, an industry group leader says the guidance left a lot of unanswered questions that will continue to create uncertainty for companies.