FDA Issues Draft Guidance on Export Certificates for Devices
The FDA released a new draft guidance on its review process for a Certificate to Foreign Government (CFG) and listed the reasons it may deny a request. Read More
AdvaMed Takes Issue With FDA Guidance on Humanitarian Device Exemption
AdvaMed said it strongly supports the FDA’s efforts to provide clarity around “probable benefits” from marketing authorizations for humanitarian use devices,… Read More
Devices News
FDA Proposes to Define Certain Device Accessories as Class I
The FDA issued a list of medical device accessories that it believes are safe and effective enough to be categorized as Class I and requested public feedback on the proposed list. Read More
Gottlieb Highlights Commitment to New Pediatric Devices
FDA Commissioner Scott Gottlieb said the agency wants to encourage the development of medical devices designed specifically for pediatric patients and noted “there are still far too few devices on the market designed specifically to trea... Read More
TGA Offers New Guidance on Electronic Instructions for Use
Australia’s Therapeutic Goods Administration issued new guidelines on electronic instructions for use for medical devices. Read More
GEM City Engineering Cited for Document Controls
A litany of major GMP deficiencies — ranging from inadequate document control procedures, CAPA, device acceptance procedures and procedures to control product — plagued GEM City Engineering and Manufacturing during a Feb. 21 to March 1 F... Read More