The Association for the Advancement of Medical Instrumentation (AAMI) is reporting that the Food and Drug Administration (FDA) has released an amendment that seeks to move up the deadlines for establishing a unique device identification (UDI) system for certain medical devices.
Â
Specifically, the amendment would apply to implantable, life-supporting and life-sustaining devices. The amendment would mean that such devices in the Class III or high-risk category would need a UDI marking one year earlier than first proposed. Implantable devices in the Class II or moderate-risk category would need a UDI marking three years earlier than first proposed. The UDI on the label and device package would be required one year earlier. Implantable devices in the Class I or low-risk category would need the UDI marking five years earlier than first proposed, with the label and device package requirement one year earlier than first proposed.
The FDA is accepting public comments on the proposed change to the UDI timeline until Dec. 19. To read further from AAMI about the public comment process, CLICK HERE.
Product Locator: Spring and Early Mother's Day Gift Guide for Infection Prevention Personnel
March 27th 2024Whether it's a spring holiday, birthdays, or no reason at all, infection prevention personnel love to give and receive gifts that help at the end of a stressful day. Infection Control Today® offers some gift ideas for infection prevention personnel and their families.
Rare Disease Day 2024: Spotlight on Rare Infectious Diseases
February 29th 2024Rare Disease Day on February 29, 2024, shines a global light on the impact of rare diseases, including rare infectious diseases. With a focus on early diagnosis and treatment access, this day highlights the struggles of those with rare conditions.
Infection Prevention in Low-Resource Settings: Two Infection Preventionists Consult in East Africa
January 29th 2024Infection preventionists Heather Saunders and Stephanie Mayoryk's journey to East Africa emphasizes the positive impact of infection prevention efforts in low-income countries. Despite challenges, their experience encourages IPs to engage globally, fostering hope and passion for providing excellent patient care.