• Login
    • Join
  • FOLLOW:
  • Subscribe Free
    • Magazine
    • eNewsletter
    Checkout
    • Magazine
    • News
    • Opinions
    • Top 30
    • Research
    • Supply Chain
    • Device Sectors
    • Directory
    • Events
    • Resources
    • Microsites
    • More
  • Magazine
  • News
  • Opinions
  • Top 30
  • Research
  • Supply Chain
  • Device Sectors
  • Directory
  • Events
  • Resources
  • Microsites
  • Current / Back Issues
    Features
    Editorial
    Digital Edition
    eNewsletter Archive
    Our Team
    Editorial Guidelines
    Reprints
    Subscribe Now
    Advertise Now
    Top Features
    Parylene Coatings for Medical Device Technologies

    The Big Shift: Nearshoring Trends in Medtech Manufacturing

    OEMs Seek Molders Offering Timely Techniques

    Robotic Surgery: Cutting Through to the Latest

    Packaging, Sterilization Considerations Go Part and Parcel with Product Development
    OEM News
    Supplier News
    Service / Press Releases
    Online Exclusives
    Press Releases
    People in the News
    Product & Service Releases
    Supplier News
    Medtech Makers
    Technical Features
    International News
    Videos
    Product & Service Releases
    Live From Shows
    Regulatory
    Financial/Business
    Top News
    'Graft-on-a-Chip' Built to Improve Vascular Graft Success

    Abbott Invests €440 in New Irish Facility

    FDA Approves Guardant Health's NGS-Based Companion Diagnostic

    Reflow Medical Completes DEEPER LIMUS Clinical Trial Enrollment

    NanoVibronix Strengthening its Supply Chain to Address Potential Delays
    From the Editor
    Blogs
    Guest Opinions
    Top Opinions
    Parylene Coatings for Medical Device Technologies

    The Big Shift: Nearshoring Trends in Medtech Manufacturing

    OEMs Seek Molders Offering Timely Techniques

    Robotic Surgery: Cutting Through to the Latest

    Packaging, Sterilization Considerations Go Part and Parcel with Product Development
    Top 30 Medical Device Companies
    Market Data
    White Papers
    Top Research
    Cooling and Melting the Pain Away

    What Are the Fundamentals of Go-To-Market Strategy in Medical Devices?

    Minding the Gap: How Harmonizing Quality Systems Pays Off

    Building Strong Partnerships Between Medtech and Surgeon-Learning Platforms

    Four Key Considerations for OEMs Transferring a Product Program
    3D/Additive Manufacturing
    Contract Manufacturing
    Electronics
    Machining & Laser Processing
    Materials
    Molding
    Packaging & Sterilization
    R&D & Design
    Software & IT
    Testing
    Tubing & Extrusion
    Cardiovascular
    Diagnostics
    Digital Health
    Neurological
    Patient Monitoring
    Surgical
    Orthopedics
    All Companies
    Categories
    Company Capabilities
    Add New Company
    Outsourcing Directory
    Xact Wire EDM Corp.

    JBC Technologies

    Concise Engineering

    Trademark Plastics Inc.

    Cirtec Medical
    MPO Summit
    Industry Events
    Webinars
    Live From Show Event
    Industry Associations
    Videos
    Career Central
    eBook
    Slideshows
    Top Resources
    Medical Computing: COM Express Processes Real-Time Data at the Edge

    The Importance of Building Successful Supplier Relationships

    The Benefits of Outsourcing Innovation in Medtech Manufacturing

    Patching Healthcare Cybersecurity Risks in the Internet of Medical Things

    Leveraging Open Healthcare Data Standards to Improve Medical Device Manufacturing
    Companies
    News Releases
    Product Releases
    Press Releases
    Product Spec Sheets
    Service Releases
    Case Studies
    White Papers
    Brochures
    Videos
    Outsourcing Directory
    Xact Wire EDM Corp.

    JBC Technologies

    Concise Engineering

    Trademark Plastics Inc.

    Cirtec Medical
    • Magazine
      • Current/Back Issues
      • Features
      • Editorial
      • Columns
      • Digital Editions
      • Subscribe Now
      • Advertise Now
    • News
    • Directory
      • All Companies
      • ALL CATEGORIES
      • Industry Associations
      • Company Capabilities
      • Add Your Company
    • Supply Chain
      • 3D/Additive Manufacturing
      • Contract Manufacturing
      • Electronics
      • Machining & Laser Processing
      • Materials
      • Molding
      • Packaging & Sterilization
      • R&D & Design
      • Software & IT
      • Testing
      • Tubing & Extrusion
    • Device Sectors
      • Cardiovascular
      • Diagnostics
      • Digital Health
      • Neurological
      • Patient Monitoring
      • Surgical
      • Orthopedics
    • Top 30 Company Report
    • Expert Insights
    • Slideshows
    • Videos
    • eBook
    • Resources
    • Podcasts
    • Infographics
    • Whitepapers
    • Research
      • White Papers
      • Case Studies
      • Product Spec Sheets
      • Market Data
    • MPO Summit
    • Events
      • Industry Events
      • Live From Show Events
      • Webinars
    • Microsite
      • Companies
      • Product Releases
      • Product Spec Sheets
      • Services
      • White Papers / Tech Papers
      • Press Releases
      • Videos
      • Literature / Brochures
      • Case Studies
    • About Us
      • About Us
      • Contact Us
      • Advertise with Us
      • eNewsletter Archive
      • Privacy Policy
      • Terms of Use
    Online Exclusives

    An Overview of the ASCA Pilot Program

    The FDA published a three-part final guidance on the voluntary program.

    An Overview of the ASCA Pilot Program
    The ASCA Pilot program was set up to foster an accredited conformity assessment arrangement between medical device manufacturers, accreditation bodies, and testing laboratories. Image courtesy of MasterControl.
    Related CONTENT
    • Auriga Inc.
    • WESTPAK, Inc.
    • BMP Medical - Delivering Custom Plastics Manufactured Solutions
    • Simbex
    • DDL Inc.
    David Jensen, Staff Writer, MasterControl03.11.21
    In September 2019, the U.S. Food and Drug Administration (FDA) Center for Device and Radiological Health (CDRH) introduced the Accreditation Scheme for Conformity Assessment (ASCA) Pilot. The program was set up to foster an accredited conformity assessment arrangement between medical device manufacturers, accreditation bodies, and testing laboratories. After receiving comments from the public and industry stakeholders, the FDA released its final guidance for the ASCA Pilot in September 2020.
     
    The Purpose of the ASCA Pilot
    In a nutshell, the FDA intends for the ASCA Pilot to use accredited, third-party testing laboratories to assess the declaration of conformity (DOC) provided by medical device manufacturers in their premarket submissions. These assessments will determine the company’s adherence to the agency’s consensus standards for safety, performance, and biocompatibility.
     
    The voluntary pilot program is designed to help make medical device and in vitro diagnostic (IVD) product premarket reviews more consistent and efficient. The agency also intends for the program to reduce the regulatory burden on device manufacturers by increasing product reviewers’ trust in medical device testing.
     
    ASCA Pilot Final Guidance
    The final guidance for the ASCA Pilot is considerably more comprehensive than the original draft. One notable variance is it includes an expanded section on the policies and processes involved in testing products. For example, guidelines regarding the organizational structure, environmental conditions, and resources of the testing laboratories include:
     
    • Ensuring staff is qualified and continually trained on methods to conduct testing within the scope of the regulations and standards.
    • Implementing procedures for governing the development, maintenance, and use of tests.
    • Maintaining testing equipment to ensure it remains in proper working order according to the accreditation requirements.
    • Setting up procedures for identifying testing errors caused by incorrect calibration or operation of equipment that could affect the accuracy and reliability of testing results.
    • Documenting and reporting all required information as detailed in ISO/IEC 17025.
     
    The FDA’s final guidance for the ASCA Pilot is dispersed across three guidance documents:
     
    • Goals and implementation of ASCA Pilot
    • Basic safety and essential performance standards
    • Biocompatibility testing of medical devices
     
    This article highlights aspects of each guidance that apply to medical device manufacturers and accredited testing laboratories participating in the ASCA Pilot.
     
    #1: ASCA Pilot – Goals and Implementation
    When the FDA first set up the ASCA Pilot in September 2019, the agency set goals for how the program will support its ongoing efforts to use its scientific resources effectively and efficiently to protect and promote public health.
     
    • Enhance confidence in medical device testing – Includes application processes and periodic audits of ASCA-recognized accreditation bodies to ensure they meet the criteria specified by the FDA.
    • Promote consistency and predictability in the premarket review process – The FDA’s commitment to clearly communicate expectations for how results from ASCA-accredited testing laboratories will be included and reviewed in premarket submissions.
    • Encourage effective use of FDA resources – Enlisting third-party organizations to participate in assessing the declaration of conformity (DOC) submissions from manufacturers allows the FDA to devote scientific and regulatory resources to other pertinent priorities.
    • Enhance regulatory efficiency – The FDA expects the application process, periodic audits, and clear communication among participants in the ASCA Pilot will decrease the need for additional information regarding testing methodologies, which will help speed up the submission process.
    • Support international harmonization – In developing the ASCA Pilot, the FDA used elements from international conformity assessment standards in the ISO/IEC 17000 series. In addition, most of the FDA-recognized consensus standards and test methods selected for the ASCA Pilot are international consensus standards.
     
    Medical device manufacturers can use testing performed by an ASCA-accredited testing laboratory to support their premarket submission as long as the laboratory uses an FDA-recognized consensus standard.
     
    #2: Basic Safety and Essential Performance Standards
    This segment of the guidance addresses the responsibilities of accredited laboratories in developing test plans and procedures. For example, tests should be project-specific and include documentation of test details the FDA has itemized in the guidance, such as:
     
    • Test identification information, including title, document number, revision, and effective date
    • Specific test equipment required
    • Warning/caution statements to alert operators of potential hazards
    • Normal and/or unusual ambient conditions, including tolerances for tests
    • Test data to be obtained and recorded
    • Objective acceptance criteria
     
    The guidance includes guidelines for inspecting the manufacturer’s risk management file to obtain objective evidence. Laboratories must also provide a list of all documents examined during the inspection.
     
    #3: Biocompatibility Testing of Medical Devices
    Finally, regulatory bodies are committed to the protection of patient safety. That said, biocompatibility, which involves screening new medical devices for the possibility of patients experiencing adverse reactions, is a pivotal component of the ASCA Pilot.
     
    To comply with the biocompatibility requirements, participant accredited bodies must conform to guidelines in the ISO/IEC 17025 standard, which explains how laboratories need to demonstrate that they operate competently and generate valid results.
     
    In addition, this segment of the guidance states that “all testing should be conducted considering the recommendations in the CDRH Biocompatibility policy as described in the FDA’s guidance ‘Use of International Standard ISO 10993-1.’” The agency created this guidance to assist medical device manufacturers with preparing premarket applications for devices that have direct or indirect contact with the human body. It advises manufacturers on using risk-based approaches to determine if biocompatibility is needed.
     
    Conclusion
    The ASCA Pilot is voluntary. Device manufacturers that choose to use an ASCA-accredited testing laboratory to conduct testing are responsible for including the appropriate information regarding device testing in their premarket submissions. The FDA is still building the ASCA Pilot. As with other pilot programs, the agency will determine at a future date if more regulations, legislation, and public input will be needed before transitioning the ASCA Pilot to a permanent program.


    David Jensen is a staff writer for MasterControl.
    Suggested For You
    Auriga Inc. Auriga Inc.
    WESTPAK, Inc. WESTPAK, Inc.
    BMP Medical - Delivering Custom Plastics Manufactured Solutions BMP Medical - Delivering Custom Plastics Manufactured Solutions
    Simbex Simbex
    DDL Inc. DDL Inc.
    RJG RJG
    High Tech Turning Co. Inc. High Tech Turning Co. Inc.
    Nissha Medical Technologies Nissha Medical Technologies
    Hangsterfer Hangsterfer's Laboratories
    sfm medical devices GmbH sfm medical devices GmbH
    Anjon Medical Technologies Anjon Medical Technologies
    IMA Automation North America IMA Automation North America
    Olympus Corporation Launches Powerseal Advanced Bipolar Surgical Energy Products Olympus Corporation Launches Powerseal Advanced Bipolar Surgical Energy Products
    Babson Diagnostics Raises $31 Million in Series B Funding Babson Diagnostics Raises $31 Million in Series B Funding
    Picarro Unveils EtO Gas Concentration Analyzer Picarro Unveils EtO Gas Concentration Analyzer

    Related Buyers Guide Companies

    • Auriga Inc.

      ...
      Aleksandr Rodionov, Marketing manager 06.09.22

    • WESTPAK, Inc.

      WESTPAK, Inc.

      ...
      Tim Eells, WESTPAK, Inc. 03.04.22

    • BMP Medical - Delivering Custom Plastics Manufactured Solutions

      BMP Medical - Delivering Custom Plastics Manufactured Solutions

      Medical Contract Manufacturing, Design, Assembly & Packaging


    • Simbex

      ...
      Greg Lange, Chief Business Development Officer 11.15.21

    • DDL Inc.

      DDL Inc.

      DDL has been in medical device package, product and material testing industry for almost 20 years. We strive to offer the most effective business practices while employing a staff of technical experts.
      Chris Murphy, Marketing Manager 11.11.21

    Loading, Please Wait..

    Trending
    • Cardinal Health CEO Mike Kaufmann Steps Down
    • BD Recalls Intraosseous Products Over Multiple Issues
    • Abbott Invests €440 In New Irish Facility
    • Medidata Unveils New Tech To Improve Clinical Trial Oversight
    • Chronic, Infectious Disease Prevalence To Benefit Vital Signs Monitoring Market
    Breaking News
    • 'Graft-on-a-Chip' Built to Improve Vascular Graft Success
    • Abbott Invests €440 in New Irish Facility
    • FDA Approves Guardant Health's NGS-Based Companion Diagnostic
    • Reflow Medical Completes DEEPER LIMUS Clinical Trial Enrollment
    • NanoVibronix Strengthening its Supply Chain to Address Potential Delays
    View Breaking News >
    CURRENT ISSUE

    July/August 2022

    • Parylene Coatings for Medical Device Technologies
    • Nearshoring Trends in Medtech Manufacturing
    • View More >

    Cookies help us to provide you with an excellent service. By using our website, you declare yourself in agreement with our use of cookies.
    You can obtain detailed information about the use of cookies on our website by clicking on "More information”.

    • About Us
    • Privacy Policy
    • Terms And Conditions
    • Contact Us

    follow us

    Subscribe
    Nutraceuticals World

    Latest Breaking News From Nutraceuticals World

    Charlotte’s Web Sports Product Line to Undergo NSF Certification Process
    ADM and Benson Hill Partner to Scale High Protein Soy for U.S. Market
    Tazo Transitions to Regenerative Organic Agriculture
    Coatings World

    Latest Breaking News From Coatings World

    SONGWON Industrial Group Reports Strong Q2 Financial Results
    PPG Completes COLORFUL COMMUNITIES Project for Boys & Girls Clubs of Greater Houston
    Paul N. Gardner Now Offers Bacharach Sling Psychrometer
    Medical Product Outsourcing

    Latest Breaking News From Medical Product Outsourcing

    'Graft-on-a-Chip' Built to Improve Vascular Graft Success
    Abbott Invests €440 in New Irish Facility
    FDA Approves Guardant Health's NGS-Based Companion Diagnostic
    Contract Pharma

    Latest Breaking News From Contract Pharma

    AskBio Appoints Clinical Ops Executives
    SpectrumX Partners With UK Contract Manufacturer
    GL Chemtec Partners with Edgewater Capital to Accelerate Growth
    Beauty Packaging

    Latest Breaking News From Beauty Packaging

    Arkay Chairman Emeritus Howard Kaneff Has Died
    Nutricosmetics Market to Hit $13.7 Billion by 2030
    Estée Lauder Pledges 100% Electric Fleet of Vehicles by 2030
    Happi

    Latest Breaking News From Happi

    J&J To Stop Global Sales of Talc-Based Products by 2023
    Net Sales Increase 2% for Naples Soap Company in Second Quarter
    Net Revenue Down 12% for Grove Collaborative in Second Quarter
    Ink World

    Latest Breaking News From Ink World

    Heidelberg Enjoys Successful Start to 2022-23 Fiscal Year
    Mimaki Announces New LATAM Website
    Paul N. Gardner Offers Bacharach Sling Psychrometer
    Label & Narrow Web

    Latest Breaking News From Label & Narrow Web

    Esko, Constantia Flexibles announce acquisitions and more
    Hybrid Software joins The Flexo Xperience Center
    Flexo Wash LLC and Mike Potter celebrate 20 years
    Nonwovens Industry

    Latest Breaking News From Nonwovens Industry

    Focke & Co. to Host Destination: Your Hygiene Hub on August 31
    Exports Dominate Chinese Trade of Tissues, Hygiene Products and Wipes
    Freudenberg to Present Friction Inserts for Wind Energy
    Orthopedic Design & Technology

    Latest Breaking News From Orthopedic Design & Technology

    Dental 3D Printing Market is Expanding 20% Annually
    Study Results Released for Abbott's Concussion Blood Test
    Bone Growth Stimulators Market to Top $3B by 2030
    Printed Electronics Now

    Latest Breaking News From Printed Electronics Now

    eMagin Corporation Announces 2Q 2022 Results
    Zebra Technologies’ Emission Reduction Targets Validated by SBTi
    Identiv Delivers Impressive 41% Year-over-Year Growth in RFID Business

    Copyright © 2022 Rodman Media. All rights reserved. Use of this constitutes acceptance of our privacy policy The material on this site may not be reproduced, distributed, transmitted, or otherwise used, except with the prior written permission of Rodman Media.

    AD BLOCKER DETECTED

    Our website is made possible by displaying online advertisements to our visitors.
    Please consider supporting us by disabling your ad blocker.


    FREE SUBSCRIPTION Already a subscriber? Login