Breaking News

Senate Bill Would Modernize FDA MedTech Inspection Process

By Advanced Medical Technology Association (AdvaMed) | February 16, 2017

This legislation will lead to a higher level of patient safety and more efficient use of inspector time and effort.

The Advanced Medical Technology Association (AdvaMed) issued the following statement from President and CEO Scott Whitaker after introduction in the U.S. Senate of bipartisan legislation (S. 404) to modernize FDA’s medical device inspections process:
 
“Both the medical technology industry and FDA recognize the need for a robust inspections process to help ensure the continued availability of safe and effective devices and diagnostics for patients.
 
“However, the agency’s current inspections process suffers from a lack of consistency, predictability, and transparency, preventing both FDA and industry from addressing quality and compliance issues in an efficient manner.
 
“The legislation introduced today by Sens. Johnny Isakson (R-Ga.) and Michael Bennet (D-Colo.) will help modernize FDA’s inspections process through a risk-based approach that will focus the agency’s limited resources on facilities that have the most potential to impact public health, improving overall patient safety.
 
The legislation would also:
 
  • Establish a process for companies to address deficiencies more quickly and robustly;
  • Create a more focused and efficient inspection process for FDA;
  • Harmonize the inspection process to eliminate regional variations; and
  • Improve communications between FDA and companies to ensure timely implementation of any remediation plans.
 
“This legislation will lead to a higher level of patient safety and more efficient use of inspector time and effort, while not taking away any of FDA’s authority to inspect device manufacturing facilities.
 
“We commend Sens. Isakson and Bennet for their leadership on this issue, and look forward to working with FDA, Congress and other stakeholders in advancing this important bill.”

Related News:

Related Manufacturing:

  • Bringing Imaging to the Cloud

    Bringing Imaging to the Cloud

    Sean Fenske, Editor||February 24, 2017
    As imaging gets more high tech, so too must the solutions that enable more convenient viewability of it.

  • Filling the Gap In Spinal Fusion

    Filling the Gap In Spinal Fusion

    Sean Fenske, Editor||January 31, 2017
    One company has addressed the “performance gap” that’s left in spinal fusion procedures with a unique technology solution.

  • The Biologic Shift

    The Biologic Shift

    Sean Fenske, Editor||January 17, 2017
    As doctors and surgeons evaluate biologic options, emerging OEMs are focusing exclusively on this type of offering.

  • Nature’s Way

    Nature’s Way

    Michael Barbella, Managing Editor||February 23, 2017
    Still in search of that magic elixir, orthobiologics firms are producing natural-based alternatives for traumatic injuries.

  • Let’s Keep It Clean, Folks

    Let’s Keep It Clean, Folks

    Sam Brusco, Associate Editor||February 23, 2017
    Ensuring devices are properly ‘cleaned and pressed’ in sterile packaging is often undervalued, but always important.

  • Surgical Sophistication

    Surgical Sophistication

    Mark Crawford, Contributing Writer||February 23, 2017
    Complex procedures, robotic systems, and infection prevention are driving innovation in surgical instrumentation.