In addition to a redesign of the TGA website and the latest fee schedule, there are some exciting new developments in the effort to form a unified regulatory system between Australia and New Zealand.

New draft guidance from the US Food and Drug Administration would reclassify some in vitro...

The Global Harmonization Task Force’s (GHTF) has issued guidance establishing a uniform, global system for adverse event reporting during pre-market clinical investigations of medical devices.

A new study by US medical device industry lobbying group Advanced Medical Technology Association (AdvaMed) finds that prices for medical devices and diagnostic products have increased at less than one-fourth the rate of other medical products and services due to high pricing competition.

The growing rate of US Food and Drug Administration inspections and warning letter issuances, already higher than last year, will continue to increase according to a report by FDANews.com (subscription required).

Mexican medical device regulators plan to establish simplified registration for in vitro diagnostics and other low-risk products, and to exempt another 1,700 health products from medical device reg

Highly anticipated draft guidance on mobile medical applications has been published by the FDA’s Center for Devices and Radiological Health (CDRH) and Center for Biologics Evaluation and Research (CBER). Targeting specific subsets of mobile medical device applications , the guidance should help answer some longstanding industry questions of how—or whether—US and other regulators would approach such devices. The guidance could furthermore serve as a template for other medical device market regulators determining how to establish requirements for this burgeoning sector of the device industry.

A new analysis of 510(k) premarket review timeframes by the US Food and Drug Administration cites response times from companies to additional information requests as the key causes of review delays. Overall, the FDA study found that between 2001 and 2010, percentages of 510(k) submissions that prompted Additional Information (AI) requests increased steadily and substantially—from 38% in 2001 to 77% in 2010. Average 510(k) decision time frames during that same period followed a similar trajectory, particularly from 2005 onward: In 2001, 510(k) decisions took an average of 102 days to reach, and in 2010 that average increased to 140 days. (These numbers track closely to a recent analysis of 510(k) clearance timeframes conducted by Emergo.)

The European Commission has published draft regulation covering electronic instructions for use in the European Union that would affect both device medical device manufacturers and notified bodies.

Drugs Control General of India (DCG(I)), the country’s regulatory agency overseeing medical devices and pharmaceuticals, is currently lacking a director, stalling all