Covid-19 PPE Enforcement Policy Goes into Immediate Effect

(HealthyExaminer.com) – On April 6, 2020, the U.S. Food and Drug Administration (FDA) will host a webinar for device manufacturers and industry to discuss and answer questions on the recently issued, immediately in effect guidances on enforcement policy for personal protective equipment (PPE) during COVID-19.

Background
The FDA issued two immediately in effect guidances on enforcement policy for personal protective equipment (PPE) during COVID-19:

Enforcement Policy for Face Masks and Respirators During the Coronavirus Disease (COVID-19) Public Health Emergency (Revised) (April 2, 2020)
Enforcement Policy for Gowns, Other Apparel, and Gloves During the Coronavirus Disease (COVID-19) Public Health Emergency (March 30, 2020)
The FDA believes the policy set forth in these guidances may help address urgent public health concerns by helping to expand the availability of:

General-use face masks for the general public;
Particulate-filtering facepiece respirators (including N95 respirators); and
Surgical apparel for health care professionals, including gowns (togas), hoods, and surgeon’s and patient-examination gloves during this public health emergency.
Webinar Details
Registration is not necessary.

Date: April 6, 2020
Time: 3:00 PM – 4:00 PM, ET
To ensure you are connected, please dial-in 15 minutes prior to the start of the webinar.

U.S. Callers Dial:

888-233-1204
Conference Number: PWXW1179161
Passcode: 6110103
International Callers Dial:

1-773-799-3794
Conference Number: PWXW1179161
Passcode: 6110103
To view the slide presentation during the webinar:
https://www.mymeetings.com/nc/join.php?i=PWXW1179161&p=6110103&t=cExternal Link Disclaimer

Following the webinar a transcript, recording and slides will be available at:
http://www.fda.gov/CDRHWebinar

We appreciate your feedback on our webinar program. Following the webinar, we will provide a link to a short survey about your FDA CDRH webinar experience, which should take no more than 5-10 minutes to complete. Your responses are confidential and will be used to help ensure the quality of our webinar program.

Note: The FDA does not provide Continuing Education Credits (CEU) or Certificates of Attendance for webinar attendance.

Target Audiences: Industry (medical device companies or distributors, technology manufacturers (including start-up companies or labs), academic and research institutions, healthcare facilities, professional societies, foundations and other non-profits

If you have any questions regarding this guidance document, please contact CDRH’s Division of Industry and Consumer Education (DICE) at dice@fda.hhs.gov, 1-800-638-2041, or 301-796-7100.

Food and Drug Administration
Center for Devices and Radiological Health

Read the full FDA Report here.

As published by HealthyExaminer.com.