All Clarivate Analytics websites use cookies to improve your online experience. They were placed on your computer when you launched this website. You can change your cookie settings through your browser.

More information on our cookie policy.

BioWorld. Link to homepage.

Powering insights from Cortellis. Link to Cortellis page on Clarivate website.
  • BioWorld
  • BioWorld MedTech
  • BioWorld Asia
  • BioWorld Science
  • Data Snapshots
    • BioWorld
    • BioWorld MedTech
  • Special reports
    • Artificial intelligence
    • Coronavirus
    • Diagnosing the state of COVID-19 testing
    • Drugs to Watch 2020
    • The next pandemic
    • Premium reports
      • BioWorld Financings Reports
      • Disease Forecast Reports

BioWorld. Link to homepage.

  • Sign In
  • Sign Out
  • My Account
Subscribe
BioWorld - Friday, January 15, 2021
See today's BioWorld MedTech
Home » Fourth time a charm as FDA finalizes POC blood glucose meter guidance
To read the full story, subscribe or sign in.

Fourth time a charm as FDA finalizes POC blood glucose meter guidance

Last updated: Sep. 28, 2020
By Mark McCarty
No Comments
The U.S. FDA’s effort to compile a guidance for prescription, point-of-care (POC) blood glucose meter (BGM) test systems seems to show that guidances can be as iterative as the devices they govern. The FDA announcement for the Sept. 28, 2020, final guidance said that the differences between the 2020 final and the 2018 draft include “a minor edit” regarding user accessibility and a technical correction for hemoglobin testing concentration, yielding a document that is finally ready for prime time after four tries over six years.
BioWorld MedTech Regulatory Diabetes Diagnostics Breast implant FDA

Popular Stories

  • British flag

    Accuracy, utility of COVID-19 lateral flow tests questioned in the U.K.

    BioWorld MedTech
    LONDON – A huge row has broken out in the U.K. about the accuracy and utility of COVID-19 lateral flow tests (LFT) in screening asymptomatic people, as a pilot...
  • Total artificial heart being manufactured

    Carmat's artificial heart receives CE mark

    BioWorld MedTech
    Carmat SA said its total artificial heart received the CE mark, and the company plans to ramp up production to enable the launch of the device in the second...
  • Today's news in brief

    BioWorld
    BioWorld briefs for Jan. 14.
  • Israeli flag

    Israel continues to shine as hub of med-tech innovation

    BioWorld MedTech
    In recent years, Israel has proven to be a hot spot for med-tech innovation. The country boasts more than 1,500 companies in the health care and life sciences...
  • Doctor examining child in wheelchair

    Sarepta DMD phase II hangs in ‘balance’ as disparity in North Star leads astray

    BioWorld
    Sarepta Therapeutics Inc.’s miss on a key phase II ambulatory endpoint in its Duchenne muscular dystrophy (DMD) trial may have been caused by a dramatic disparity...
cortellis ad

BioWorld Premium

Enjoy extended coverage for the most complete market view with BioWorld, BioWorld MedTech, and BioWorld Asia in a single, easy to access subscription.

Subscribe
  • BioWorld
    • Today's news
    • Analysis and data insight
    • Clinical
    • Data Snapshots
    • Deals and M&A
    • Financings
    • Newco news
    • Opinion
    • Regulatory
    • Science
  • BioWorld MedTech
    • Today's news
    • Clinical
    • Data Snapshots
    • Deals and M&A
    • Financings
    • Newco news
    • Opinion
    • Regulatory
    • Science
  • BioWorld Asia
    • Today's news
    • Analysis and data insight
    • Australia
    • China
    • Clinical
    • Deals and M&A
    • Financings
    • Newco news
    • Regulatory
    • Science
  • BioWorld Science
    • About
    • Archives
    • Today's news
    • Search BioWorld Science
  • More
    • About
    • Archives
    • Article reprints and permissions
    • Contact us
    • Cookie policy
    • Copyright notice
    • Data methodology
    • Privacy policy
    • Share your news with BioWorld
    • Staff
    • Terms of use
A Clarivate Analytic solution. Link to Clarivate website.
Follow Us

Copyright ©2021. All Rights Reserved. Design, CMS, Hosting & Web Development :: ePublishing