miércoles, 16 de mayo de 2018

N95 regulation update | Expanding collaborations to improve BSL-4 data quality | New food defense training

U.S. Food and Drug Administration - Medical Countermeasures Initiative Update
FDA exempts certain N95 respirators from premarket notification requirements
Streamlining regulation of PPE essential to public health emergency response
Protecting the health and safety of first responders and healthcare workers is an essential part of planning for public health emergencies. Personal protective equipment (PPE) items such as respirators, protective clothing, and eye protection are standard supplies.

One type of respirator routinely used to protect both the patient and healthcare provider from the transfer of microorganisms, body fluids, and particulate material is known as an N95 respirator (pictured). N95s are single-use, disposable respiratory protective devices. 
N95 respirators
FDA and CDC’s National Institute for Occupational Safety and Health (NIOSH) share regulatory oversight of N95 respirators. In a final order released on May 16, 2018, FDA is exempting certain N95s from premarket notification [510(k)] requirements, and executing a Memorandum of Understanding with NIOSH.

The final order and MOU streamline the regulation of N95s to help manufacturers easily identify, understand, and work to meet marketing requirements, and help ensure the availability of safe and effective medical products, particularly during times of increased demand, such as a public health emergency.  This final action will also decrease regulatory burden on the medical device industry and will eliminate costs required to comply with certain Federal regulations.
Image: N95 face mask respirators. These respirators protect people who wear them by removing contaminants from the air. (Credit: CDC/ Debora Cartagena)
Ensuring data quality in BSL-4 labs
FDA course expands domestic and international collaborations in sixth year
Much of the work to develop medical countermeasures for high-priority agents must be done in high and maximum biosafety level (BSL)-4 laboratories to prevent the agents from being released into the environment, and to provide maximum safety for the scientists.

In another sold-out class, FDA and the University of Texas Medical Branch (UTMB) convened 50 scientists and regulators from industry, academia, and government for an intensive, week-long course on ensuring data quality in maximum-containment labs.
2018 Achieving Data Quality in Maximum Containment Laboratories course participants group photo
Participants—including public health agency collaborators from eight countries—completed practice exercises while wearing full BSL-4 suits. Interactive lectures and discussions included the challenges of Ebola human clinical trials, the Animal Rule, and best practices to achieve Good Laboratory Practices (GLP) while managing BSL-4 studies.
Image: Course participants on April 26, 2018. In partnership with the National Interagency Confederation for Biological Research (NICBR), the course included lectures and tours at the United States Army Medical Research Institute of Infectious Diseases (USAMRIID) and the National Institute of Allergy and Infectious Diseases (NIAID) Integrated Research Facility (IRF) in Frederick, Maryland. (Credit: UTMB)
  Related links: 
EUA updates
Emergency Use Authorization, with emergency sign
Zika diagnostic test performance characteristics
Laboratory personnel using Zika diagnostic assays under EUA are encouraged to report performance concerns directly to FDA at CDRH-EUA-Reporting@fda.hhs.gov, in addition to reporting concerns to the manufacturer.

Information about Zika EUAs and amendments is available on the FDA Zika virus response updates page. Also see the latest CDC Zika Laboratory Guidance, last updated July 24, 2017.
Information for industry
More: MCM-Related Guidance by Date
In case you missed it

No hay comentarios: