The Food and Drug Administration (FDA)'s Center for Devices and Radiological Health (CDRH) has posted a list of guidance documents under consideration for development, including items on infusion pumps and 510(k) modifications.
The list, which covers items that may be published in fiscal year 2012, is the result of negotiations between the FDA and industry over the reauthorization of the Medical Device User Fee and Modernization Act. In exchange for additional funding from industry, the FDA says it agreed to annually post a list of guidance documents CDRH is considering, and allow stakeholders to weigh in.
"CDRH believes this docket is an important tool for receiving information from interested parties and for making information available to the public," the FDA says in a notice about the initiative.
Specific topics that may be covered in new guidance documents include:
- Medical devices that include antimicrobial agents
- Distinguishing and reporting medical device recalls from product enhancements
- Appropriate use of consensus standards in premarket submissions
- Design considerations for pivotal clinical investigations
- Design considerations for devices labeled for home use
The agency cautions that not all of these topics will become guidance documents and that there could be guidance documents that are not currently on the list. "Our experience over the years has shown that there are many reasons CDRH staff does not complete the entire annual agenda of guidances it undertakes," the notice reads. "Staff are frequently diverted from guidance development to other activities, including review of premarket submissions or post market problems."
Dear Helpdesk: Working in a Toxic Health Care Environment
March 28th 2024Dear Helpdesk is your steadfast companion, offering life coaching and workplace advice from 2 seasoned IPs for some of your most challenging real-life situations. Let us help you navigate the intersection between work and life, guiding you to navigate the dynamic world of infection prevention with confidence and grace. This article is on handling a toxic health care environment.
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.
Catching Up With Vangie Dennis, AORN 2022-2023 President at AORN 2024
March 26th 2024Infection Control Today (ICT) had the privilege of catching up with Vangie Dennis, MSN, RN, CNOR, CMLSO, at the Association of periOperative Registered Nurses' (AORN’s) International Surgical Conference & Expo 2024. As the former president of AORN and an esteemed figure in perioperative services, Vangie Dennis shared insights into her recent endeavors and the exciting new chapter she's embarked upon.
How To Optimize Your Time Management Strategies for the Busy Infection Preventionist
March 25th 2024Is your calendar resembling a chaotic masterpiece of overlapping tasks? Join the club of infection preventionists striving to balance responsibilities. Dive into proven strategies from a fellow infection preventionist to reclaim control of your time, streamline tasks, and boost productivity effectively. This is an IP Lifeline article.