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:

  • Rear View Mirror Reflections

    Rear View Mirror Reflections

    Michael Barbella, Managing Editor||March 20, 2017
    AAOS past president discusses his tenure leading the organization.

  • The Shift to Outpatient Total Joint Replacements

    The Shift to Outpatient Total Joint Replacements

    Roger Massengale, General Manager, Acute Pain, Halyard Health||March 15, 2017
    As physicians look to shift patients to a same-day surgical option, technology addresses pain management.

  • Thrombosis: Examining New Preventative Measures

    Thrombosis: Examining New Preventative Measures

    Anthony Kjenstad, Founder and President, Athletic Recovery and Performance||March 9, 2017
    A new, wearable, wrist-watch sized device could offer patients a convenient alternative to current options.

  • Testing Your Patience

    Testing Your Patience

    Mark Crawford, Contributing Writer||March 22, 2017
    Changing FDA guidance and new technologies make device testing a challenging proposition for medtech OEMs.

  • Out of Ideas

    Out of Ideas

    Michael Barbella, Managing Editor||March 22, 2017
    Cost pressures, specialization, and customized solutions are currently driving orthopedic R&D.

  • Made of Sterner Stuff

    Made of Sterner Stuff

    Sam Brusco, Associate Editor||March 22, 2017
    Orthopedic materials are challenged to migrate away from metal while retaining metallic strength.