Per the FDA, the draft guidance is intended to help clarify whether activities performed on devices are likely "remanufacturing." Such clarification is intended to help provide consistency and better understanding of applicable statutory and regulatory requirements. The draft guidance also provides recommendations for information that should be included in labeling to help assure the continued quality, safety and effectiveness of devices that are intended to be serviced over their useful life.
Filter your results:
6 Results Found
Aug 26, 2021
Jun 23, 2021
The Occupational Safety and Health Administration (OSHA) issued an emergency temporary standard (ETS) on Monday, June 21, to protect health care workers from occupational exposure to COVID-19. The ETS applies, with some exceptions, to health care settings where people may share space with COVID-19 patients or interact with others who do. The ETS requires health care employers to develop and implement a COVID-19 plan that identifies and controls COVID-19 hazards in the workplace.
Jan 23, 2020
ASHE has acknowledged proven best practices and partnered with health care professionals to provide a tool to enable health care organizations to manage their most valuable assets. This will aid users in articulating a risk assessment model, and it will provide a comprehensive explanation of how the model enables organizations to maintain compliance. Download the Tool
Oct 9, 2019
- In 2016, the Centers for Medicare & Medicaid Services (CMS) adopted new Conditions of Participation that incorporated the 2012 editions of NFPA 101 and NFPA 99. CMS recently provided ASHE with the following guidance on some frequently asked questions regarding the new CMS requirements.
May 8, 2019
The 2017 ASHE Advocacy Report includes articles on improving codes, code compliance, and outreach. DOWNLOAD NOW