1. FDA Developing New Pathway for Device Clearance

    FDA Developing New Pathway for Device Clearance

    'Data show that nearly 20 percent of current 510(k)s are cleared based on a predicate that’s more than 10 years old. 'That doesn’t mean the products are unsafe. But it does mean that some devices may not be continually improving, which is the hallmark of health technologies,' Gottlieb and Shuren added.

    To advance its goals, the agency is considering making public on its website a list of cleared devices that have demonstrated substantial equivalence to older predicate devices. It is considering focusing on predicates that are more than 10 years old as a starting point, so that the public is aware of those technologies.

    Read Full Article
  1. Topics Mentioned

  2. Beacon Promotional Product Web Store

     

    Click on the picture to go to our web store and find out special of the day.  You can also contact us with any questions.  Email us at:  Sales@Beacon-SM.com

     

  3. BLN Newsletter Supporters:

     

     

    Consulting and Outsourcing, Business development for our clients.

    Beacon now also offers thousands of Promotional Products with your logo.

    We provide our clients with qualified leads.

     

  4. Robert Williams Leading CPA in OC, CA.

  5. Independent Insurance

    health, Life, Medicare, Long Term Care, Disability & Retirement Planning

  6. Starfish Signs & Graphics

  7. Categories

    1. Balanced Living:

      BLN Blogs, Financial, Good News, Lighter Side of Life, Mental, Physical, Social, Spiritual
    2. Communities:

      Bike, Business, High Tech