Medtech Insight is part of Pharma Intelligence UK Limited

This site is operated by Pharma Intelligence UK Limited, a company registered in England and Wales with company number 13787459 whose registered office is 5 Howick Place, London SW1P 1WG. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction

FDA Tempers Accuracy Standards For Hospital Glucose Meters In Final Guidance

Executive Summary

The US agency finalized two closely watched guidance documents for blood glucose systems used in the hospital and at home. The guidance focusing on hospital point-of-care systems included a key revision of proposed accuracy standards from a 2014 draft guidance that had been broadly maligned as too tough.

You may also be interested in...



US FDA Redrafts Glucose Meter Guidances With Small Updates

The agency finalized two parallel guidance documents in 2016 relating to hospital point-of-care and patient over-the-counter use of blood glucose meters. But it has now reissued the documents in draft form to make what an agency spokeswoman referred to as "mostly minor" changes.

US FDA Panel To Tackle Hospital Glucose Meter Accuracy Issue

FDA says it has become aware of large data sets that raise new questions about the level of accuracy that blood glucose meters can deliver in an intensive-care hospital setting using capillary blood samples. An advisory panel will be tasked March 30 with considering the issue and its impact on assessing risk-benefit of the devices in the hospital environment.

First Glucose Meter Cleared For Hospital ICUs As FDA Continues Work On Guidance

FDA hopes the clearance of Nova Biomedical’s Nova StatStrip blood glucose monitor for hospitalized patients will help alleviate fears that increased regulatory standards will restrict critically ill patients’ access to point-of-care glucose testing. But the clearance does not necessarily settle the agency’s long-term policy plans for hospital-use glucose meters.

Related Content

Topics

Related Companies

Latest Headlines
See All
UsernamePublicRestriction

Register

MT103936

Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel