We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
  • SKIP TO CONTENT
  • SKIP NAVIGATION
  • Drug Products
    • Books
    • FDAnews Books Library
    • Events
    • Form 483s Database
    • Subscription Newsletters
    • Free Newsletters
    • Webinar Training Pass
    • eCFR and Guidances
  • Device Products
    • Books
    • FDAnews Books Library
    • Events
    • Form 483s Database
    • Subscription Newsletters
    • Free Newsletters
    • Webinar Training Pass
    • eCFR and Guidances
  • Clinical Products
  • Advertising
  • White Papers
  • Contact Us
  • About Us
  • COVID-19
  • Sign In
  • Create Account
  • Sign Out
  • My Account
Home » LDT, BioCompatibility Final Guidance Make AdvaMed’s Priority List

LDT, BioCompatibility Final Guidance Make AdvaMed’s Priority List

March 27, 2015

The U.S. FDA should finalize guidance documents on premarket and postmarket data collection, the proposed laboratory-developed tests framework and adverse event reporting, and biocompatibility standards before attacking other priorities, AdvaMed says.

The suggestions come in response to a recent device center document listing priorities in guidance development (IDDM, Jan 9). The agency divided planned guidances into “A” and “B” lists in the report.

In comments posted recently to regulations.gov, AdvaMed urged the FDA to finalize all existing draft guidance for which the comment periods have closed as quickly as possible, but singled out the four documents on the center’s “A” list as particularly important to devicemakers. They are:

  • Balancing Premarket and Postmarket Data Collection for Devices Subject to Premarket Approval;
  • Framework for Regulatory Oversight of Laboratory Developed Tests;
  • FDA Notification and Medical Device Reporting for Laboratory Developed Tests; and
  • Use of ISO 10993-1, Biological Evaluation of Medical Devices Part I: Evaluation and Testing (Biocompatibility).

The letter also asks the FDA to prioritize final guidance on human factors testing, exempting certain devices from 510(k) clearance, expediting access for devices intended to treat unmet needs and reprocessing devices in healthcare settings.

AdvaMed deemed most of the draft guidance the FDA plans to issue this year of medium priority, with the exception of one calling for the use of symbols in device labeling, which the group considers more important.

In addition, several documents not mentioned in the report should be considered high priority, the group said. These include updates to guidance on premarket approval modifications and manufacturing site changes, and device-specific guidance on codevelopment and nonmolecular types of multimarker panels. AdvaMed also wants to see an update of 2013 guidance on presenting risk-benefit information in space-limited internet platforms such as Twitter.

Eleven older guidances should also be reviewed and updated, AdvaMed said.

View AdvaMed’s comment at www.fdanews.com/03-30-13-advamed.pdf. — Elizabeth Orr

Regulatory Affairs

Upcoming Events

  • 26Apr

    MAGI's Clinical Research vConference — Spring 2021

  • 06May

    The World of Post-COVID-19 Clinical Trials: How to Prepare for What’s Coming Next

  • 12May

    Extractables and Leachables: 101

  • 19May

    CDRH’s New Accreditation Scheme for Conformity Assessment: Impacts on Your Future Testing Plans and FDA Submissions

  • 25May

    How Can the Accelerated Availability of Pfizer-BioNTech’s COVID-19 Vaccine be Replicated?

  • 27May

    Evolving Clinical Trials: Continuing the Journey from Paper to Digital

Featured Products

  • Biological Risk Evaluation and Management for Medical Devices

  • GMP Inspection Preparation Checklist: A Tool for Internal Auditing

Featured Stories

  • Fujifilm_Logo.gif

    Fujifilm Begins Late-Stage Trial of Avigan for COVID-19

  • CE mark

    DiaSorin’s 10-Minute COVID-19 Antibody Test CE Marked

  • WHO

    WHO Will Review Two COVID-19 Vaccines from China

  • CE mark

    Qiagen’s High Throughput COVID-19 Test Earns CE Mark

The Revised ICH E8: A Guide to New Clinical Trial Requirements

Learn More
  • Drug Products
    • Quality
    • Regulatory Affairs
    • GMPs
    • Inspections and Audits
    • Postmarket Safety
    • Submissions and Approvals
    • Research and Development
    • Commercial Operations
  • Device Products
    • Quality
    • Regulatory Affairs
    • QSR
    • Inspections and Audits
    • Postmarket Safety
    • Submissions and Approvals
    • Research and Development
    • Commercial Operations
  • Clinical Products
    • Trial Design
    • Data Integrity
    • GCP
    • Inspections and Audits
    • Transparency
  • Privacy Policy
  • Do Not Sell My Personal Information
Footer Logo

300 N. Washington St., Suite 200, Falls Church, VA 22046, USA

Phone 703.538.7600 – Fax 703.538.7676 – Toll free 888.838.5578

Copyright © 2021. All Rights Reserved. Design, CMS, Hosting & Web Development :: ePublishing