UA-1777106-1
skip to main content
  • About Medmarc
  • Contact
Medmarc - Treated Fairly
  • LinkedIn Icon Link
  • YouTube Icon Link
  • Blog Icon Link
  • Twitter Icon Link

Toll free number 888-633-6272

  • Insurance Solutions
  • Broker Resources
  • Risk Management
  • Claims Management
  • Life Sciences News and
    Resources
  • FAQs
  • Apply for Coverage
  • Report a Claim
  • COVID-19 Pandemic Response

Toll free number 888-633-6272

  • Search
  • About Medmarc
  • Contact
  • Social
    • LinkedIn
    • YouTube
    • Blog
    • Twitter
  • Insurance Solutions
  • Broker Resources
  • Risk Management
  • Claims Management
  • Life Sciences News and Resources
  • FAQs
  • Apply for Coverage
  • Report a Claim
  • COVID-19 Pandemic Response
  • Home
  • Life Sciences News and Resources
  • blog.medmarc.com

blog.medmarc.com

  • News and Resources Overview
  • blog.medmarc.com
  • Announcements
  • Events
  • Publications
  • Webinars
  • Videos

House User Fee Bill Emphasizes Inspections

May 16, 2022

The House of Representatives is processing legislation to renew the FDA’s user fee programs, a bill that includes a number of key provisions for drug and device makers alike. The bill is likely to be...

User Fees Could Reach $1.9 Billion in MDUFA V

April 28, 2022

Negotiations between FDA and industry regarding the reauthorization of the Medical Device User Fee Amendments (MDUFA V) are complete and the final commitment letter summarizing the deal is expected to...

AdvaMed Revises its Code of Ethics

April 27, 2022

The Advanced Medical Technology Association (AdvaMed) is the largest medical technology association, representing life sciences device, diagnostics, and digital technology manufacturers. The...

FDA Reissues 2018 Draft Guidance for Cybersecurity

April 11, 2022

The FDA has released a draft guidance for cybersecurity in medical devices, which is a revised version of a similar document published in October 2018. If enacted as a final guidance as written,...

FDA’s Device Center Issues Two Guidances for Appeals

March 30, 2022

The FDA has released two guidances for appeals of regulatory decisions, one each for mammography facilities and the other for medical device premarket reviews. These are the first two final guidances...

FDA Publishes Finalized Guidance Document for Pre-Launch Activities Importation Requests (PLAIR)

March 24, 2022

On March 2, 2022, the US Food and Drug Administration (FDA) published the finalized guidance document titled, “Pre-Launch Activities Importation Requests,” or PLAIR. This document was updated from the...

Preparedness Emphasized in FDA Voluntary Recall Guidance

March 7, 2022

The FDA final guidance for voluntary recalls applies to all FDA product centers, devices and drugs included, and offers some clarity regarding terminology. However, the agency urged companies to take...

FDA Strives to Harmonize 21 CFR Part 820 with ISO 13485:2016

February 28, 2022

The Food and Drug Administration (FDA) has continued to move towards harmonizing U.S. regulations with international standards for the regulation of medical devices. On February 23, 2022, FDA...

FDA Released Finalized Guidance Document for Combination Products

February 14, 2022

In January 2022, FDA released a new final guidance document titled, ‘Principles of Premarket Pathways for Combination Products’ which has caused many manufacturers to reevaluate their FDA compliance...

FDA Discussion Paper Addressing 3D Printing of Medical Devices at the Point of Care

February 11, 2022

The U.S. Food and Drug Administration's (FDA's) Center for Devices and Radiological Health (CDRH) issued a discussion paper titled, ‘3D Printing Medical Devices at the Point of Care’. FDA requested...

  • 1
  • 2
  • 3
  • 4
  • 5
  • »

Subscribe to Medmarc's News and Resources

Medmarc Insurance Group Logo
  • Insurance Solutions
  • Broker Resources
  • Risk Management
  • Claims Management
  • Life Sciences News and Resources
  • FAQs
  • Apply for Coverage
  • Report a Claim
  • COVID-19 Pandemic Response
  • About Medmarc
  • Diversity, Equity, and Inclusion
  • Contact
  • Investor Relations
  • Search
  • Legal Disclaimer
  • Privacy Policy
  • Trademark
  • Careers
  • LinkedIn Icon Link
  • YouTube Icon Link
  • Blog Icon Link
  • Twitter Icon Link
  • Phone Number
  • Toll free number 888-633-6272
  • Copyright © 2022 Medmarc. All Rights Reserved.