Medical device labeling guidelines have been updated by the U.S. Food and Drug Administration (FDA) with the aim of clarifying the ways in which medical devices may be labeled in order to prevent confusion for caregivers, patients and medical staff.
The FDA’s final rule has established a system for the unique identification of medical devices that is based on their use and means of distribution. As the system becomes fully implemented, device labels will carry a unique device identifier (UDI). Companies responsible for device labelling are also required to submit certain information pertaining to each device to the FDA’s Global Unique Device Identification Database (GUDID) so that the public can search for and download this information. Continue reading
General medical device labelling requirements are outlined in the FDA’s 21 CFR Part 801. This documentation outlines the minimum requirements for all medical devices. Here is an abbreviated rundown on the 5 most common medical device labeling requirements. Continue reading
The Prescription Drug Marketing Act (PDMA) was signed into law by President Ronald Reagan on April 22, 1988. Its purpose is twofold: to ensure that medicinal products purchased by consumers are both effective and safe to use, and to protect U.S. consumers from misbranded, adulterated, counterfeit, under-active, or expired prescription drugs. Prior to the establishment of the PDMA, legislators felt that U.S. consumers were unable to buy prescription drugs with the confidence and certainty that the medications were effective and safe. This was found to be a result of three factors: Continue reading
Unique Device Identification (UDI) refers to a system that is designed to mark the labels of medical devices used within the healthcare system. The U.S. FDA released a final ruling on the system in 2014. The system is intended to be fully implemented over the next several years. Continue reading
10 Things to Know
21 CFR Part 11 is a section of Title 21 of the Code of Federal Regulations that authorizes the U.S. FDA rules and regulations related to electronic records and electronic signatures (ERES). It outlines the criteria which designate ERES to be a reliable equivalent to paper records. Here are ten important things you need to know about 21 CFR Part 11. Continue reading
As promised, the AIM Healthcare Committee is in the process of understanding and developing thought around the impact and opportunity of UDI in a healthcare provider setting. Lisa Fohey CMRP PMP, Director of Supply Chain at the Children’s Hospital of Wisconsin, will be giving a presentation on the topic of the impact and the opportunity of UDI in a healthcare provider setting at the next AIM Healthcare Committee meeting, this coming Thursday January 15th 2015 at 10:00am Eastern.
Meeting GS1 Barcode Labeling Requirements
GS1 barcode labeling can be an essential component of accurate supply chain management. Without GS1, many companies in a variety of industries may find it nearly impossible to track shipments and identify products as they make their way through the vast network of transportation channels that funnels goods throughout the world. Meeting the GS1 barcode labeling requirements is one way for a company to prevent loss of products and to comply with industry logistics standards. Continue reading
The Federal Drug Administration (FDA) classifies medical devices. There are three main classifications Class I, Class II, and Class III. The assignment of a classification for a device depends upon the level of risk that is associated with the device. Continue reading
The U.S. Food and Drug Administration (FDA) released the final rule on a Unique Device Identifier (UDI) system on September 20, 2013. The system, along with the Global Unique Device Identification Database (GUDID) was 10 years in the making and is a vital step toward increasing the safety of medical devices. One of the most significant changes is the elimination of the requirement that all implantable medical devices—such as pacemakers and heart valves—have the UDI printed on the device itself. Originally the proposed rule required manufacturers to mark the UDI directly onto the following types of devices: Continue reading
The U.S. Food and Drug Administration (FDA) has established a unique device identifier system(UDI) to facilitate the identification of medical devices. UDI guidelines specify proper usage of the unique device identifier in both human- and machine-readable forms and are intended to enhance the safety of healthcare workers, patients and caregivers. Manufacturers of medical devices are required to enter each device’s information into the FDA’s Global Unique Device Identification Database (GUDID), which will enable the public to search, access and download information about specific devices. Continue reading