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Global Regulatory Guidelines: Medtech Guidance Tracker, July 2016

Executive Summary

Stay up to date on regulatory guidelines from around the world, with Medtech Insight's Guidance Tracker, with documents updated through July 2016.

Shutterstock: Stuart Miles

[Editor's note: Check out the complete global Medtech Guidance Tracker with sortable and searchable listings going back to 2014 here.]

Fifteen new guidance documents on medical device and in vitro diagnostics from global regulatory authorities were added to Medtech Insight's Guidance Tracker in July. The most guidelines last month came from US FDA, with nine documents, including two draft guidelines on next generation sequencing.

Also on the updated list, a draft guideline from Malaysia explaining how change of ownership may impact the device registration process, and a revised final guideline from South Africa outlining essential principles of safety and performance of devices and IVDs.

The July guidance document listing is below, with links to each guideline.

Medtech Guidance Tracker: July 2016

Country

Organization

Document

Status

International

IMDRF

Competence, Training and Conduct Requirements for Regulatory Reviewers

Draft

International

WHO

WHO manual for organizing a national external quality assessment programme for health laboratories and other testing sites

Final

EU

EC

MEDDEV 2.1/6 - Qualification and Classification of stand alone software

Final

Ireland

HPRA

Guide to Information held by the HPRA (Tracked version)

Final

Malaysia

MDA

Medical device guidance document: Change of ownership for medical device registration

Draft

South Africa

MCC

Medical Devices and IVDs Essential Principles of Safety & Performance

Final

US

FDA

Use of Standards in FDA Regulatory Oversight of Next Generation Sequencing (NGS)-Based In Vitro Diagnostics (IVDs) Used for Diagnosing Germline Diseases: Draft Guidance for Stakeholders and Food and Drug Administration Staff

Draft

US

FDA

Use of Public Human Genetic Variant Databases to Support Clinical Validity for Next Generation Sequencing (NGS)-Based In Vitro Diagnostics: Draft Guidance for Stakeholders and Food and Drug Administration Staff

Draft

US

FDA

Principles for Co-development of an In Vitro Companion Diagnostic Device with a Therapeutic Product: Draft Guidance for Industry and Food and Drug Administration Staff

Draft

US

FDA

Unique Device Identification System: Form and Content of the Unique Device Identifier (UDI): Draft Guidance for Industry and Food and Drug Administration Staff

Draft

US

FDA

Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices: Draft Guidance for Industry and Food and Drug Administration Staff

Draft

US

FDA

Adaptive Designs for Medical Device Clinical Studies: Guidance for Industry and Food and Drug Administration Staff

Final

US

FDA

Information to Support a Claim of Electromagnetic Compatibility (EMC) of Electrically-Powered Medical Devices: Guidance for Industry and Food and Drug Administration Staff

Final

US

FDA

General Wellness: Policy for Low Risk Devices – Guidance for Industry and Food and Drug Administration Staff

Final

US

FDA

FY 2017 Medical Device User Fee Small Business Qualification and Certification – Guidance for Industry, Food and Drug Administration Staff and Foreign Governments

Final

Key:

  • IMDRF: International Medical Device Regulators Forum
  • WHO: World Health Organization
  • EC: European Commission
  • HPRA: Health Products Regulatory Authority
  • MDA: Medical Device Authority
  • MCC: Medicines Control Council
  • FDA: Food and Drug Administration
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