Medical Design Technology
Published on Medical Design Technology (https://www.mdtmag.com)

Home > FDA Updates Guidance on Pulse Oximeter Applications

FDA Updates Guidance on Pulse Oximeter Applications

The FDA publishes guidance for pre-market notification submissions for pulse and blood oxygen level monitors.

FDA

The FDA issued new guidance governing premarket notification submissions for pulse oximeters. The new guidelines apply to all 510(k) submissions for the non-invasive blood oxygen level and pulse rate measuring devices.

In the guidance [1], published March 4, the FDA specified new rules for identifying, testing and assuring safety for the systems. The new document overrides the 1992 guidance on the same category. The FDA's goal is to help device companies prepare their premarket notifications, or 510(k)s, for any pulse oximeter.

Content Item Type: 
News [2]
Meta Canonical URL: 
http://www.mdtmag.com/news/2013/03/fda-updates-guidance-pulse-oximeter-applications
Summary: 

The FDA issued new guidance governing premarket notification submissions for pulse oximeters. The new guidelines apply to all 510(k) submissions for the non-invasive blood oxygen level and pulse rate measuring devices. In the guidance, published March 4, the FDA specified new rules for identifying, testing and assuring safety for the systems.

Contributed Author: 
Mass Device
Legacy NID: 
146 721

Deeper Insights

<% if ( rc.ss_related_image_url != null ){ %>
?cmpid=regwallcontent&utm_source=Deeper%20Insights">">
<% } %>

?cmpid=regwallcontent&utm_source=Deeper%20Insights" + ""><%- rc.label %>

<% if ( rc.ss_search_logo != null ){ %>
">
<% } %>
Advertisement
googletag.cmd.push(function() { googletag.display("dfp-ad-clone_of_wallpaper"); });
(function() { var _fbq = window._fbq || (window._fbq = []); if (!_fbq.loaded) { var fbds = document.createElement('script'); fbds.async = true; fbds.src = '//connect.facebook.net/en_US/fbds.js'; var s = document.getElementsByTagName('script')[0]; s.parentNode.insertBefore(fbds, s); _fbq.loaded = true; } _fbq.push(['addPixelId', '745881082149515']); })(); window._fbq = window._fbq || []; window._fbq.push(['track', 'PixelInitialized', {}]);
(function(d,s,i,r) { if (d.getElementById(i)){return;} var n=d.createElement(s),e=d.getElementsByTagName(s)[0]; n.id=i;n.src='//js.hs-analytics.net/analytics/'+(Math.ceil(new Date()/r)*r)+'/1743435.js'; e.parentNode.insertBefore(n, e); })(document,"script","hs-analytics",300000);

Connect with Medical Design Technology

  • Facebook
  • Twitter
  • YouTube

Resources

  • About Us
  • Advertising Info
  • Contact Us
  • Contributor Guidelines
  • Digital Editions
  • Directory FAQs
  • Privacy Policy
  • Product Announcement Form
  • Subscriptions
  • Terms & Conditions

Topics

  • Cardiovascular
  • Diabetes
  • Home Healthcare
  • Implantables
  • Medical Diagnostics
  • Neurology
  • Oncology
  • Orthopedics
  • Pain Management
  • Prosthetics
  • Regenerative Medicine
  • Surgical
  • Wearables

© Copyright 2018 Advantage Business Marketing

var _qevents = _qevents || []; (function() { var elem = document.createElement('script'); elem.src = (document.location.protocol == "https:" ? "https://secure" : "http://edge") + ".quantserve.com/quant.js"; elem.async = true; elem.type = "text/javascript"; var scpt = document.getElementsByTagName('script')[0]; scpt.parentNode.insertBefore(elem, scpt); })(); _qevents.push({ qacct:"p-jsEPJWTckjCbE" });
Quantcast
googletag.cmd.push(function () { googletag.display("dfp-ad-roadblock_modal"); });
"" style="border: 0px; vertical-align: bottom;">
googletag.cmd.push(function() { googletag.display("dfp-ad-roadblock_modal"); });

Source URL: https://www.mdtmag.com/news/2013/03/fda-updates-guidance-pulse-oximeter-applications

Links
[1] http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM081352.pdf
[2] https://www.mdtmag.com/content-item-types/news