Necessary automated external defibrillator accessories: policy regarding compliance date : guidance for industry, stakeholders, health care professionals, and Food and Drug Administration staff

Necessary automated external defibrillator accessories: policy regarding compliance date : guidance for industry, stakeholders, health care professionals, and Food and Drug Administration staff

Collection:
Health Policy and Services Research
Series Title(s):
Guidance for industry
Contributor(s):
United States. Department of Health and Human Services, issuing body.
United States. Food and Drug Administration, issuing body.
Center for Devices and Radiological Health (U.S.), issuing body.
Publication:
[Silver Spring, MD] : Center for Devices and Radiological Health, October 28, 2020
Language(s):
English
Format:
Text
Subject(s):
Defibrillators
Device Approval
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration
Genre(s):
Technical Report
Abstract:
FDA is issuing this guidance to revise its compliance policy regarding the deadline for filing premarket approval (PMA) applications for previously cleared accessories necessary to the operation of automated external defibrillator (AED) systems. This policy is based, in part, in consideration of the burden on healthcare facilities as they transition to FDA-approved AEDs and on the manufacturers as they prepare to implement the PMA requirements while addressing the challenges related to Coronavirus Disease 2019 (COVID-19).
Copyright:
The National Library of Medicine believes this item to be in the public domain. (More information)
Extent:
1 online resource (1 PDF file (3 pages)).
NLM Unique ID:
9918231190306676 (See catalog record)
Permanent Link:
http://resource.nlm.nih.gov/9918231190306676