2012年 10月 1日

FDA Urged to Develop Security Plan for Wireless Implantable Medical Devices

The US Government Accountability Office (GAO) has issued recommendations that the Food and Drug Administration develop a comprehensive plan to improve the agency’s ability to review and monitor active implantable medical devices that rely on wireless and other advanced technologies.
2012年 9月 21日

US FTC Issues Advertising, Privacy Guidelines for Mobile Medical App Makers

It’s not just the US Food and Drug Administration mulling over how to regulate mobile medical applications these days. The US Federal Trade Commission (FTC) has also recently come out with guidelines for medical app developers targeting advertising and privacy issues. The FTC recommendations cover basic legal requirements that medical app manufacturers must meet in order to market their products, introducing obligations for these companies to be met along with FDA medical device registration requirements.
2012年 4月 9日

FDA Lists Final Guidance on 513(g) Requests for Information

The US Food and Drug Administration has published final guidance on its process for accepting and responding to 513(g) Requests for Information from medical device manufacturers and sponsors.
2012年 5月 10日

New FDA Guidance Targets Pediatric Exposure to X-Ray Devices

The US Food and Drug Administration is planning new premarket notification requirements for manufacturers of X-ray
2012年 5月 22日

FDA Report Slams EU Medical Device Approval Process

A new report issued by the US Food and Drug Administration argues that the European Union's regulatory system fails to ensure safety of high-risk medical devices it approves .
2012年 6月 7日

CDRH Process for Resolving Internal Medical Device Review Disagreements Needs Improving

Processes in place to resolve scientific disagreements among FDA medical device reviewers need stronger definitions and clearer lines of responsibility, according to the US Health and Human Service
2012年 6月 22日

FDA Guidance would Reclassify Implanted Blood Access Devices to Class II (Special Controls)

New draft guidance from the US Food and Drug Administration (FDA) would allow reclassification of implanted blood access devices for hemodialysis procedures to Class II (special controls).
2012年 7月 10日

US MDUFA Changes Signed into Law (Finally)

( Update: The following blog entry was revised on July 23, 2012 to reflect the most recent fee schedule in place at the FDA.) The Medical Device User Fee Amendments of 2012 (MDUFA III) providing increased funding for the US Food and Drug Administration have been signed into law as part of the FDA Safety and Innovation Act (FDASIA) by President Obama following months of intense negotiations between medical device industry and regulatory representatives.
2012年 8月 23日

Important changes to US FDA establishment registration requirements

There are important changes coming soon from the US FDA that may affect your company...
2012年 9月 12日

FDA Details New Medical Device Registration and Listing Requirements

The US Food and Drug Administration has published a list of frequently asked questions regarding

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