BioWorld. Link to homepage.

Clarivate
  • BioWorld
  • BioWorld Science
  • BioWorld Asia
  • Data Snapshots
    • Biopharma
    • Medical technology
    • Infographics: Dynamic digital data analysis
    • Index insights
    • NME Digest
  • Special reports
    • Infographics: Dynamic digital data analysis
    • Trump administration impacts
    • Med-tech outlook 2026
    • Under threat: mRNA vaccine research
    • BioWorld at 35
    • Biopharma M&A scorecard
    • Bioworld 2025 review
    • BioWorld MedTech 2025 review
    • BioWorld Science 2025 review
    • Women's health
    • China's GLP-1 landscape
    • PFA re-energizes afib market
    • China CAR T
    • Alzheimer's disease
    • Coronavirus
    • More reports can be found here

BioWorld. Link to homepage.

  • Sign In
  • Sign Out
  • My Account
Subscribe
BioWorld - Friday, March 6, 2026
Home » Blogs » BioWorld MedTech Perspectives

BioWorld MedTech Perspectives
BioWorld MedTech Perspectives RSS FeedRSS

Controversial 510(k) changes still up in the air

March 1, 2011
By Holland Johnson
In January when the FDA unveiled its 25-point plan to change the 510(k) clearance program, currently the quickest and most commonly used pathway to getting a medical device to market in the U.S., it appeared that a smooth landing might be in the works for the med-tech industry. That landing, however, was deferred, saddling the program with one of the greatest annoyances to any airline passenger, the dreaded holding pattern, when it was revealed that 30 other more controversial recommendations from the FDA working groups were being delayed. Among the most contentious recommendations being postponed was one for CDRH...
Read More
Previous 1 2 … 43 44 45 46 47 48 49 50 51 Next

Popular Stories

  • Today's news in brief

    BioWorld
    BioWorld briefs for March 6, 2026.
  • Brain and virus with chromosome

    CROI 2026: Neurodegeneration, the challenge of aging with HIV

    BioWorld
    Antiretroviral therapies against HIV have been in use for more than 30 years and have enabled people living with HIV to maintain undetectable viral levels. Many...
  • Depression concept with human, broken brain and heavy rain

    CROI 2026 highlights depression and cognitive vulnerability in HIV

    BioWorld
    The effects of aging pose an additional challenge for people with HIV due to the neurological and psychological consequences that persist despite antiretroviral...
  • News in brief

    BioWorld Asia
    BioWorld Asia briefs for March 3, 2026
  • Concept art for headache

    Slate Medicines launches with focus on headache disorders

    BioWorld Science
    Slate Medicines Inc. has launched with $130 million in series A financing and a focus on advancing next-generation therapeutics for migraine and other headache...
  • BioWorld
    • Today's news
    • Analysis and data insight
    • Clinical
    • Data Snapshots
    • Deals and M&A
    • Financings
    • Medical technology
    • Newco news
    • Opinion
    • Regulatory
  • BioWorld Science
    • Today's news
    • Biomarkers
    • Cancer
    • Conferences
    • Endocrine/metabolic
    • Immune
    • Infection
    • Neurology/psychiatric
    • NME Digest
    • Patents
  • BioWorld Asia
    • Today's news
    • Analysis and data insight
    • Australia
    • China
    • Clinical
    • Deals and M&A
    • Financings
    • Newco news
    • Regulatory
    • Science
  • More
    • About
    • Advertise with BioWorld
    • Archives
    • Article reprints and permissions
    • Contact us
    • Cookie policy
    • Copyright notice
    • Data methodology
    • Infographics: Dynamic digital data analysis
    • Index insights
    • Podcasts
    • Privacy policy
    • Share your news with BioWorld
    • Staff
    • Terms of use
    • Topic alerts
Follow Us

Copyright ©2026. All Rights Reserved. Design, CMS, Hosting & Web Development :: ePublishing