Devices & Diagnostics Letter

The Office of Management and Budget has approved the FDA’s long-awaited proposed rule on a unique device identifier (UDI), clearing it for release by the agency.

President Barack Obama signed the FDA Safety and Innovation Act, S. 3187, into law July 9, reauthorizing the Medical Device User Fee Act (MDUFA) and Prescription Drug User Fee Act, and creating new user fee programs for generic drugs and biosimilars.

A pair of FDA final guidances may make it easier for companies to gain approval of devices that use computer software to analyze data gathered during radiology.

House Republicans, joined by a handful of Democrats, voted Wednesday to repeal the 2010 Affordable Care Act (ACA) — the 31^st time the GOP has tried to take down or truncate the law, House Democrats said..

Under a new draft guidance, the FDA’s Pre-IDE Program will be renamed the Pre-Submission Program and cover a broad range of applications — from IDEs, PMAs and 510(k)s to humanitarian device exemptions, de novo filings and more.

Makers of home use medical test kits must be able to demonstrate that they can be properly used by people who lack specialized training, the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) says in new guidance for notified bodies.

OraSure Technologies plans to begin rolling out its OraQuick In-Home HIV Test in drugstores and online in October, following FDA approval this month.

Roche Molecular Systems is preparing a September launch for the first FDA-approved DNA test to measure viral load of cytomegalovirus (CMV) in solid organ transplant patients undergoing antiviral treatment.

An optical supplies manufacturer has received an FDA warning letter for nine violations, most relating to complaint handling, device design and process control procedures.

Makers of hip, knee and shoulder joint implants have two years from July 1, 2012 to apply for their products to be transitioned from Class IIb to Class III devices in Australia, the Therapeutic Goods Administration (TGA) said.