• E-mail
• Print
• RSS

FDA offers tips for premarket submissions for coronary and carotid embolic protection devices

Device Regulation Alert: Safety, Compliance and Reimbursement News, March 3, 2008

New FDA guidance issued February 15 provides device manufactures with advice on preparing premarket notification submissions for coronary and carotid embolic protection devices that remove substances loosened during interventional procedures.

The guidance provides information for evaluation protocols and developing labeling for the devices. The FDA will use the guidance when it reviews 510(k) premarket submissions for these devices. That means manufacturers would be wise to carefully consider the recommendations in the guidance when preparing their submissions.

In the guidance, the FDA recommends that manufacturers submitting 510(k) applications for the devices:

• Identify the device by regulation and product code
• Describe characteristics and performance specifications.
• Compare the device to existing devices
• Address risks related to use of the device such as device failure, infection, tissue and blood damage and embolization
• Perform biocompatibility testing on devices that have contact with circulating blood for a limited time.
• Test the devices durability and performance
• Submit clinical data from trials of the device or scientifically-based reasoning for why that data isn't necessary
• Include sterilization and labeling information

• Comment
• E-mail to a Colleague
• Print
• RSS
• Archive

Comments