• Skip to primary navigation
  • Skip to main content
  • Skip to primary sidebar
  • Skip to footer
  • Advertise
  • Subscribe

MassDevice

The Medical Device Business Journal — Medical Device News & Articles | MassDevice

  • Latest News
  • Technologies
    • Artificial Intelligence (AI)
    • Cardiovascular
    • Orthopedics
    • Neurological
    • Diabetes
    • Surgical Robotics
  • Business & Finance
    • Wall Street Beat
    • Earnings Reports
    • Funding Roundup
    • Mergers & Acquisitions
    • Initial Public Offering (IPO)
    • Legal News
    • Personnel Moves
    • Medtech 100 Stock Index
  • Regulatory & Compliance
    • Food & Drug Administration (FDA)
    • Recalls
    • 510(k)
    • Pre-Market Approval (PMA)
    • MDSAP
    • Clinical Trials
  • Special Content
    • Special Reports
    • In-Depth Coverage
    • DeviceTalks
  • Podcasts
    • MassDevice Fast Five
    • DeviceTalks Weekly
    • OEM Talks
      • AbbottTalks
      • Boston ScientificTalks
      • DeviceTalks AI
      • IntuitiveTalks
      • MedtechWOMEN Talks
      • MedtronicTalks
      • Neuro Innovation Talks
      • Ortho Innovation Talks
      • Structural Heart Talks
      • StrykerTalks
  • Resources
    • About MassDevice
    • DeviceTalks
    • Newsletter Signup
    • Leadership in Medtech
    • Manufacturers & Suppliers Search
    • MedTech100 Index
    • Videos
    • Webinars
    • Whitepapers
    • Voices
Home » FDA: Average PMA time to decision hits record low

FDA: Average PMA time to decision hits record low

February 26, 2016 By Fink Densford

FDAThe FDA released a report today detailing its stats for pre-market approvals and 510(k) applications for 2015 and the 1st 3 months of 2016, hitting a high-water mark for its time-to-decision for PMAs.

The FDA reported a significant improvement in the average decision time for PMAs, which cover high-risk Class III devices, clocking in at an average of 209 days. That’s a 20% improvement from last year’s average of 262 days, and the lowest time to decision on record for the federal safety watchdog.

The FDA said its percentage of PMAs approved dipped to 91% in the 1st 3 months of 2016, a 7% fall from its record high 98% approval rate in 2015. The numbers are still 5% higher than they were in 2014 at 86%.

For simpler 510(k)s, the agency reported stable numbers in the 1st 3 months of 2016, at 85%. That’s the same as the FDA clocked in 2015 and only 1% higher than its rate of approval in 2014.

The average time to 510(k) decisions decreased 14%, falling from 127 days in 2014 to 109 days in 2015, the lowest time to decision the agency has seen since 2006.

Filed Under: 510(k), Food & Drug Administration (FDA), Pre-Market Approval (PMA), Regulatory/Compliance Tagged With: FDA

More recent news

  • Aurora Spine begins first procedures with Aero lumbar fusion system
  • Caranx Medical surgical robot TaviPilot AI software wins FDA clearance
  • InspireMD launches carotid stent in U.S. after FDA approval
  • Neuros Medical raises $56M Series D to support nerve stim tech
  • CorWave reports first-in-human LVAD implant

Primary Sidebar

“md
EXPAND YOUR KNOWLEDGE AND STAY CONNECTED
Get the latest med device regulatory, business and technology news.

DeviceTalks Weekly

See More >

MEDTECH 100 Stock INDEX

Medtech 100 logo
Market Summary > Current Price
The MedTech 100 is a financial index calculated using the BIG100 companies covered in Medical Design and Outsourcing.
MDO ad

Footer

MASSDEVICE MEDICAL NETWORK

DeviceTalks
Drug Delivery Business News
Medical Design & Outsourcing
Medical Tubing + Extrusion
Drug Discovery & Development
Pharmaceutical Processing World
MedTech 100 Index
R&D World
Medical Design Sourcing

DeviceTalks Webinars, Podcasts, & Discussions

Attend our Monthly Webinars
Listen to our Weekly Podcasts
Join our DeviceTalks Tuesdays Discussion

MASSDEVICE

Subscribe to MassDevice E-Newsletter
Advertise with us
About
Contact us

Copyright © 2025 · WTWH Media LLC and its licensors. All rights reserved.
The material on this site may not be reproduced, distributed, transmitted, cached or otherwise used, except with the prior written permission of WTWH Media.

Privacy Policy