2011年 6月 17日

CDRH Takes More Proactive Approach with Notice to Industry Letters

The FDA’s Center for Devices and Radiological Health (CDRH) has published a
阅读更多
2011年 6月 20日

FDA Rolls Out Global Strategy to Oversee Imports

The US Food and Drug Administration (FDA) has launched a new strategy detailed in a new report, the Pathway to Global Product Safety and Quality , to better monitor increasing numbers of imported medical devices and other regulated products hitting the US market. The report calls for a more global approach to regulation of products that fall under the FDA’s purview, recommending four initiatives to carry out the new strategy:
阅读更多
2011年 7月 26日

FDA Clarifies When Device Modifications Require New 510(k)s

New 510(k) submissions. The new guidance, 510(k) Device Modifications: Deciding When to Submit a 510(k)...
阅读更多
2011年 7月 20日

New FDA Study: Insufficient 510(k) Submissions Causing Bulk of 510(k) Review Delays

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.)
阅读更多
2011年 7月 19日

Finally, Draft FDA Guidance on Mobile Medical Apps

Highly anticipated draft guidance on mobile medical applications has been published by the FDA’s Center for Devices and Radiological Health (CDRH) and Center for Biologics Evaluation and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.
阅读更多
2011年 7月 15日

Volume of FDA Warning Letters to Keep Increasing

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).
阅读更多
2011年 7月 15日

AdvaMed Study: Competition Keeping US Medical Device Pricing Low

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.
阅读更多
2011年 7月 12日

FDA Proposes Exempting Some In Vitro Devices from 510(k) Review

New draft guidance from the US Food and Drug Administration would reclassify some in vitro...
阅读更多
2011年 6月 24日

Draft Guidance on Human Factors and Usability Engineering Issued by FDA

The US Food and Drug Administration (FDA) has published a 37-page draft guidance for industry on proper human factors testing and medical device design optimization.
阅读更多
2011年 6月 23日

FDA’s Medical Device Recall Process Under Fire from GAO

A new report from the US Government Accountability Office (GAO) has found that the Food and Drug Administration (FDA) has not consistently analy
阅读更多

Pages