Exporting medical devices from the United States often requires a certificate for products regulated by the FDA. An export certificate gives information from the FDA on the product’s regulatory status. The FDA has revised medical device export certificates fees for the second time since the program began in 1996. Medical device export certificate processing costs have gone up over … Read More
Electronic Medical Device Reporting
Electronic Medical Device Reporting (eMDR) requires medical device manufactures and importers to submit medical device reports (MDRs) in an appropriate electronic format so the information can then be processed, reviewed, and archived by the FDA. The eMDR final rule will be effective on August 14, 2015. There are two options for submitting eMDRs: eSubmitter or Health Level 7 Individual Case … Read More
AccessGUDID Open for Public Use
AccessGUDID is now open for public use. The FDA has released data for devices with unique device identifiers (UDI) to the public through a website called AccessGUDID. The FDA’s final guidance in 2013 explains the UDI purpose and requirements. A UDI must be included on most device labels and packages, and device identification information must be submitted to the FDA’s Global Unique Device … 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
Medical Device Recall vs. Enhancement
The Distinguishing Medical Device Recalls from Medical Device Enhancements guidance addresses questions and inconsistencies that arise when making changes to a marketed device. When determining whether a change to a device is classified as a recall or enhancement, you should always carefully review all appropriate regulations. The FDA defines a medical device recall as “a firm’s removal or correction of … Read More
Medical Device Data Systems, Medical Image Storage Devices, and Medical Image Communications Devices Draft Guidance
The Medical Device Data Systems, Medical Image Storage Devices, and Medical Image Communications Devices draft guidance has been released to communicate the FDA’s standpoint on enforcing regulatory controls in regards to digital health efforts. The FDA understands that medical device access to digital technology has the opportunity to create more efficient and improved patient care. This draft guidance discusses how … Read More
OMEDtech YouTube Channel
OMEDtech has recently launched it’s first video on our YouTube channel. This video gives a brief overview of how OMEDtech meets the needs of the medical device community. Please take a moment to check out OMEDtech’s first video and subscribe to our channel so that you don’t miss any of our upcoming video presentations.