CDRH Research Programs provide users with a wealth of information covering a variety of topics and clinical areas. The CDRH has released a new webpage providing more information on its Research Programs. The new webpage allows users to search research by special topic or by clinical area, including: Anesthesiology, General Hospital, Respiratory, Infection Control, Dentistry, Cardiovascular, Neurology and Physical Medicine, Orthopedics, … Read More
GUDID Data Submission Compliance Update
The unique device identification (UDI) rule is being implemented by device classification, with varying compliance dates to the Global Unique Device Identification Database (GUDID). The GUDID system was temporarily taken offline on August 7, 2015 for security reasons. Since the system was unavailable the FDA has decided to extend the September 24, 2015 compliance date for the implantable, life-supporting and … Read More
General Wellness: Policy for Low Risk Devices
The FDA has issued a draft guidance document to provide information for low risk products that promote a healthy lifestyle. CDRH defines general wellness products as products that “are intended for only general wellness use, and present a very low risk to users’ safety.” A general wellness product must either help to maintain a general state of health, or help to reduce the risk or … Read More
UDI Update
The FDA’s Center for Devices and Radiological Health (CDRH) has issued an update on the upcoming Unique Device Identifier (UDI) requirements. Upcoming compliance dates for UDI requirements are: September 24, 2015 for non-class III implantable, life-supporting, and life-sustaining (I/LS/LS) devices September 24, 2016 for class II devices Upcoming dates for Global Unique Device Identification Database (GUDID) Data Submission: January 2015, they will … Read More
UDI Extension
The FDA released their final rule for UDI on September 20, 2013. Most medical devices will require a UDI or Universal Device Identifier. The UDI will have many benefits such as improved product information and faster product identification for problems or recalls. The UDI is a unique code made up of two parts. The UDI Rule gives criteria for labeling, … Read More
Export Certificates and CDRH
The CDRH has released a letter stating that as of March 1, 2014 they will no longer be notarizing FDA CDRH export certificates. The FDA is not under any obligation to provide this service but they have been fulfilling this role. These notarized documents from the FDA have been official and have needed no further action for verification. If you … Read More
CDRH Releases New Strategic Priorities for 2014
The CDRH has released their new strategic priorities for 2014. They will focus on three different areas of improvement with specific goals and deadlines for each area. Their overall goal is for patients to have access to safe and effective medical devices as soon as possible. To accomplish this goal they are looking to make improvements that would encourage medical … Read More