MassDevice

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

Home » FDA: Average PMA time to decision hits record low

FDA: Average PMA time to decision hits record low

By

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.

In case you missed it

RSS From Medical Design & Outsourcing

  • COVID-19 immunity test developers at MIT seek diagnostic manufacturer
    MIT researchers have developed a device for predicting an individual’s COVID-19 immunity and are looking for a diagnostic company to get it manufactured in large numbers and approved by the FDA. The lateral flow test uses the same technology as at-home rapid antigen COVID-19 tests to measure neutralizing antibodies for SARS-CoV-2 in a blood sample,… […]
  • GE Healthcare picks AI imaging startups for inaugural Edison Accelerator
    GE Healthcare and Nex Cubed have selected seven companies focused on artificial-intelligence-augmented medical imaging for the first cohort of the Edison Accelerator in Canada. The companies will be matched with mentors and test their technologies with GE’s new Edison Digital Health Platform over the next three months. The program will end with innovation showcase presentations… […]
  • Boston Scientific whistleblower launches corruption investigation
    Boston Scientific (NYSE:BSX) is investigating claims that the company violated the U.S. Foreign Corrupt Practices Act in Vietnam. Marlborough, Massachusetts–based Boston Scientific disclosed receipt of a whistleblower’s allegations in its latest filing with the Securities and Exchange Commission. “In March 2022, the company received a whistleblower letter alleging Foreign Corrupt Practices Act violations in Vietnam.… […]
  • 5 essential leadership lessons from Cathy Burzik for medtech’s next generation of women leaders
    Cathy Burzik, a seasoned senior executive in the healthcare industry, has successfully led major medical device, diagnostic, diagnostic imaging and life sciences businesses. Cathy Burzik, CFB Interests (as told to MedExecWomen co-founder Maria Shepherd) One key to being a successful women leader in MedTech: “Play nice, but play to win.” Cathy Burzik, who received a… […]
  • Stratasys plans to buy Covestro’s additive manufacturing business
    Stratasys (Nasdaq:SSYS) said today that it has a deal to purchase the additive manufacturing materials business of Covestro. The deal includes R&D facilities and activities, global development and sales teams across Europe, the U.S. and China, a portfolio of approximately 60 additive manufacturing materials, and hundreds of patents and patents pending, Stratasys said in a… […]
  • New implant design prevents scar tissue without drugs, MIT says
    Mechanically inflating and deflating an implantable device for 10 minutes a day prevents immune cells from building the scar tissue that has been a major obstacle for artificial pancreas researchers. That’s according to new findings from a team of MIT engineers who built mechanical deflection into a two-chambered, soft polyurethane device tested on mice. By… […]
  • Blue Spark’s TempTraq catches fevers faster. Fever prediction is next.
    Blue Spark Technologies developed the first wireless continuous temperature monitor patch, TempTraq, to enable faster fever detection than standard manual readings every four hours. Westlake, Ohio-based Blue Spark is now looking at fever prediction rather than just detecting them. The R&D team is working on developing an AI neural network model built on the company’s… […]
  • Harvard researchers plan to sell at-home, PCR-grade COVID testing system
    The Harvard University researchers who developed an ultrasensitive, PCR-grade nucleic acid detection technology plan to commercialize it as a portable COVID-19 test. Harvard Medical School professor Peng Yin, who also leads the Wyss Institute for Biologically Inspired Engineering’s Molecular Robotics Initiative, founded 3EO Health to sell the device. “In order to optimize the value of… […]
  • FDA reports sterilization challenge progress as EPA takes aim at EtO emissions
    The FDA offered an update on its efforts to make medical device sterilization safer as the EPA identified 23 U.S. facilities where use of ethylene oxide (EtO) presents a risk to communities. The FDA said it is similarly concerned about unsafe EtO emissions and highlighted work with the medical device industry to reduce EtO usage… […]
  • AdvaMed defends EtO facilities on EPA’s cancer risk list
    The Advanced Medical Technology Association (AdvaMed) today reacted to the EPA’s listing of commercial sterilization facilities causing elevated risks of cancer with a defense of the facilities and a call for more research. AdvaMed CEO and President Scott Whitaker said all of the listed facilities are in compliance with regulations and warned against closures. “The… […]
  • EPA flags high-cancer-risk EtO sterilization facilities across the country
    The EPA today identified nearly two dozen U.S. cities where commercial sterilizers using ethylene oxide (EtO) contribute to an elevated cancer risk for residents of surrounding communities. EtO is used on about 20 billion medical devices each year — or about half of all sterile medical devices —  and in some cases it’s the only… […]