MassDevice

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

Home » FDA seeks comment on device reclassification process

FDA seeks comment on device reclassification process

By

FDA

The FDA is looking for public comment on the medical device reclassification process, through which interested parties can request that a device be subject to more or less regulatory oversight.

The classification system determines a device’s regulatory pathway, with Class III devices subject to the most control and Class I devices subject to "general controls" on branding, registration and other mostly administrative concerns.

Bumping a device into a lower class means manufacturers can bring similar products to the U.S. market more quickly and with fewer regulatory hurdles.

The FDA opened up a public comment period today, extending to mid-January, to get perspective on whether the information gathered during reclassification submissions is necessary and useful, whether it’s gauge on timing and burden is appropriate, and how to improve on the process and minimize burden.

The agency is also looking for ideas on how to use automated collection techniques and other forms of information technology to make the submission process easier.

The watchdog agency estimated that it reviews about six reclassification submissions each year. Each submission takes about 500 hours to process, amounting to about 3,000 hours every year spent on making reclassification decisions.

Suggestions and comments must be sent to the FDA by January 13, 2012, according to an agency notice.

In case you missed it

RSS From Medical Design & Outsourcing

  • EPA delayed notifying residents of ethylene oxide emissions
    The EPA delayed notifying neighbors of an Illinois medical device sterilization plant of ethylene oxide (EtO) emissions the agency measured in 2018, according to an inspector general’s report released yesterday. The report also says that “leadership” in the agency’s Office of Air and Radiation also failed to conduct public meetings with residents either near the… […]
  • 9 medical devices you should keep an eye out for in 2021
    The medical device industry weathered the COVID-19 pandemic well — and is now set to roll out a host of innovations in 2021. Economists generally expect the U.S. to see a boom as we emerge from the pandemic and resulting recession. Medtech companies appear set to ride the wave this year, with plans to seek… […]
  • Greenlight Guru to provide QMS to NIH diagnostics program
    NIH has chosen Greenlight Guru to provide quality management software for its COVID-19 rapid diagnostics program. The agency launched the Rapid Acceleration of Diagnostics (RADx) program in March 2020 to speed the development, commercialization and implementation COVID-19 testing technologies. As the only QMS provider currently available to all projects in the RADx program, Greenlight Guru… […]
  • MicroCare names CFO
    MicroCare (New Britain, Conn.) has announced the appointment of John Stardellis as the company’s new chief financial officer (CFO). Stardellis joins MicroCare with more than 20 years’ experience in a variety of finance, policy and operational leadership roles. Most recently, he served as CFO at i-Health, a division of DSM Nutritional Products. “John’s track record with… […]
  • Mayo Clinic helps launch two new companies for improved diagnostics
    Mayo Clinic announced that it is introducing a new technology platform to support two new companies it has launched. Rochester, Minn.–based Mayo Clinic’s Remote Diagnostics & Management Platform (RDMP) is designed to connect data with new AI algorithms and augment human decision-making within existing clinical workflows, according to a news release. Get the full story… […]
  • Intertek gains FDA nod for premarket device testing
    Intertek has won accreditation under an FDA pilot program for testing laboratories, the company said this week. The accreditation authorizes Intertek’s 12 “medical centers of excellence” to perform premarket testing of devices for the U.S. market. The Accreditation Scheme for Conformity Assessment pilot program is a voluntary program developed to provide increased confidence in testing… […]
  • HHS shoots down ‘flawed’ plan to let some devices skip review
    The Biden administration has nixed what it described as a “flawed” Trump-era decision to exempt certain medical devices — including infusion pump controllers and fetal monitors — from regulatory review. HHS published the original notice in the Federal Register on Jan. 15, shortly before President Joe Biden was set to take office, without speaking with… […]
  • More than 50 medtech testing sites win FDA pilot accreditation
    The FDA announced today that more than 50 laboratory sites were chosen to participate in its program for streamlined regulatory reviews. In total, 53 sites made the FDA’s initial list for participation in its Accreditation Scheme for Conformity Assessment (ASCA) program, which will set out to support more streamlined regulatory reviews of medical device market… […]
  • Medline Industries up for sale?
    Medline Industries is looking for a buyer in a deal that could be worth $30 billion, according to a report in the Wall Street Journal. The Journal cites “people familiar with the matter” saying that Northfield, Ill.-based Medline has hired Goldman Sachs to manage the process. The people added that the company might alternatively seek… […]
  • Micro to add plant in Costa Rica
    Contract manufacturer Micro today announced plans to open a new plant in Costa Rica. The 32,000 ft² facility will significantly increase Micro’s cleanroom assembly capacity, according to the Somerset, N.J.-based company. It will be located in the Zona Franca Metro business park and is expected to open in late 2021 with operations beginning in 2022.… […]
  • Survey shows solid medical device industry performance despite pandemic
    By Stewart Eisenhart, Emergo Group Medical device and IVD manufacturers report healthy performance over the course of 2020, but also faced significant operational and regulatory challenges related to the coronavirus pandemic. Get the full story here at the Emergo Group’s blog. The opinions expressed in this blog post are the author’s only and do not… […]

Leave a Reply