By EAS Senior Consultant Kevin Walls
The Food and Drug Administration has recently implemented two new rules that affect all medical device manufacturers, initial distributors and repackager/relabelers.
The first new rule that went into effect on September 24, 2014, but up until now affected fewer than 10 percent of medical device manufactures, initial distributors and repackager/relabelers, is the Unique Device Identification (UDI) System. The agency is phasing in the UDI system over seven years. The new rule, established under 21 CFR Part 830, requires labels and device packages of medical devices distributed in the United States to include a UDI including easily readable plain text and Automatic Identification and Data Capture (AIDC) technology – usually a bar code.
The UDI rule also requires specified product information be submitted to FDA’s Global Unique Device Identification Database (GUDID). Most of the information in GUDID will be made available to the public. According to FDA, when fully implemented, the UDI system will serve several important public health objectives:
- It will facilitate the healthcare community, industry, and the public’s rapid and accurate identification of a device using the UDI that appears on the device’s label and device package.
- Medical providers, patients and others will be able to more easily access important information concerning the device, thereby reducing medical errors.
- It will allow more accurate reporting, reviewing, and analyzing of adverse event reports so that problems can be identified and corrected more quickly.
- It will provide a standard and clear way to document device use in electronic health records, clinical information systems, claims data sources and registries, leading to a more robust postmarket surveillance system which can be leveraged to support premarket approval or clearance of new devices and new uses of currently marketed devices.
- It will enable manufacturers, distributors and healthcare facilities to more effectively manage medical device recalls.
FDA has accredited certain Issuing agencies to operate a system for the issuance of unique device identifiers. The information contained in the UDI must also be submitted to FDA using the GUDID. The manufacturer, initial distributor or repackager/relabeler whose name appears on the device label is considered the labeler and is responsible for complying with this new requirement. The labeler must designate an individual as the Regulatory Contact, which may be an employee of the labeler or a consultant. The Regulatory Contact is responsible for making sure that the labeler meets GUDID submission requirements.
EAS Consulting Group can assist your company by playing the role of Regulatory Contact or by acting as your company’s Third Party Submitter to submit your products’ UDIs to the GUDID.
electronic Medical Device Reports (eMDRs)
The second new rule, which goes into effect on August 13, 2015, is related to electronic Medical Device Reports (eMDRs), which is covered under 21 CFR Part 803. According to the FDA “Each year, the FDA receives several hundred thousand medical device reports of suspected device-associated deaths, serious injuries and malfunctions.” The new rule requires that all MDR reports MUST be filed electronically using FDA’s Electronic Submissions Gateway (ESG). In order to submit eMDRs via FDA’s ESG, you must either set up a Web Trader Account or work with a consulting firm that has a Web Trader Account.
EAS can help you set up a Web Trader Account so you can generate and submit eMDRs, or can generate and submit eMDRs for your company using EAS Consulting Group Web Trader Account.