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Medtech guidance digest September 2014

This article was originally published in SRA

Executive Summary

Simply click on the links to access the documents.

Country

Organization

Title

Status

International

AHWP

Adverse Event Reporting Timelines Guidance forMedical Device Manufacturer and its AuthorisedRepresentative

Draft

International

AHWP

Playbook for Implementation of a Medical DeviceRegulatory Framework

Draft

US

FDA

Internet/Social Media Platforms with Character Space Limitations: Presenting Risk and Benefit Information for Prescription Drugs and Medical Devices

Draft
Comment period reopened until 29 October

US

FDA

Internet/Social Media Platforms: Correcting Independent Third-Party Misinformation About Prescription Drugs and Medical Devices

Draft
Comment period reopened until 29 October

US

FDA

Content and Format for Abbreviated 510(k)s for Early Growth Response 1 (EGR1) Gene Fluorescence In-Situ Hybridization (FISH) Test System for Specimen Characterization Devices

Draft

US

FDA

Custom Device Exemption

Final

US

FDA

Class II Special Controls Guideline: Dengue Virus Nucleic Acid Amplification Test Reagents

Final

US

FDA

Class II Special Controls Guideline: Tryptase Test System as an Aid in the Diagnosis of Systemic Mastocytosis - Guideline for Industry and Food and Drug Administration

Final

US

FDA

Highly Multiplexed Microbiological/Medical Countermeasure In Vitro Nucleic Acid Based Diagnostic Devices - Guidance for Industry and Food and Drug Administration Staff (PDF - 799KB)

Final

US

FDA

Recommendations for Screening, Testing, and Management of Blood Donors and Blood and Blood Components Based on Screening Tests for Syphilis

Final

US

FDA

Policy Clarification for Fluoroscopic Equipment Requirements

Draft

Key

AHWP – Asian Harmonization Working Party

FDA – Food and Drug Administration

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