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Aerobiotix Announces FDA 510(k) Clearance of Medical Ultraviolet Air Filtration System

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AAAHC Releases Updated Toolkit Outlining Ambulatory Procedure Considerations for Obese Patients

To help ASCs implement necessary precautions and prevent negative outcomes for obese patients, the Accreditation Association for Ambulatory Health Care (AAAHC) has published a fully revised Ambulatory Procedure Considerations for Obese Patients Toolkit.

FDA Updates Information on Respirator Decontamination Systems

The U.S. Food and Drug Administration (FDA) is reissuing the Emergency Use Authorizations for decontamination systems that are authorized to decontaminate compatible N95 respirators for use by healthcare personnel (HCP) to prevent exposure to pathogenic biological...

Collaborative Communities: FDA Participates in 5 New Communities

Since the summer of 2020, the U.S. Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) began participating in 5 new collaborative communities in the medical device ecosystem:

  • The goal of the Case for Quality Collaborative Community (CfQcc) is transitioning from baseline regulatory compliance to sustained, predictive practices that advance medical device quality and safety to achieve better patient outcomes.
  • The mission of the Heart Valve Collaboratory (HVC) is to create a dynamic, interactive collaborative community of stakeholders focused on catalyzing clinical research, advancing regulatory science, addressing knowledge gaps, and creating meaningful advances in understanding valvular heart disease.
  • The overall goal of the Wound Care Collaborative Community (WCCC) is to help assure patients and health care professionals have access to safe, effective, and high-quality medical devices and drugs to treat chronic wounds.
  • The Pathology Innovation Collaborative Community (PIcc) aims to facilitate innovations in pathology that may advance the evaluation of safety and effectiveness of devices and harmonize approaches to speed delivery of devices to patients using collaborative, precompetitive approaches.
  • The mission of the RESCUE (REducing SuiCide Rates Amongst IndividUals with DiabEtes) Collaborative Community is to reduce rates of intended self-injury and suicidal acts by people with diabetes through improved understanding of the risk factors and implementing strategies to address them.

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Collaborative Communities

A collaborative community is a continuing forum in which private- and public-sector members, which can include the FDA, work together on medical device challenges to achieve common objectives and outcomes. Participation in collaborative communities was one of the FDA’s Center for Devices and Radiological Health’s (CDRH) strategic priorities for 2018-2020.

The FDA currently participates as a member of 10 collaborative communities, which have been established and are managed and controlled by external stakeholders. The FDA has reached the goal set as part of CDRH’s 2018-2020 Strategic Priorities of participating in 10 new collaborative communities by December 31, 2020, and is open to participating in others.

Questions?
If you have questions about collaborative communities, or if you have a collaborative community in which you would like the FDA to participate, email CDRHCollabCommunities@fda.hhs.gov.

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