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Highly anticipated draft guidance on mobile medical applications has been published by the FDA’s Center for Devices and Radiological Health (CDRH) and Center for Biologics Evaluation and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.
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2011年 8月 29日

FDA Recommends Risk-Based Approaches to Monitoring Clinical Investigations

New guidance from the US Food and Drug Administration recommends investigational device exemptions (IDEs) and Investigational New Drugs (INDs).
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2011年 8月 18日

August 23rd Deadline for FDA Final Rule on Three Obsolete Class III Devices

A final FDA rule affecting ventricular bypass devices , pacemaker repair or replacement material
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2011年 8月 18日

FDA Proposes Longer Post-Market Surveillance Requirements for Pediatric Devices

New draft guidance from the US Food and Drug Administration recommends compliance pathways for medical device manufacturers regarding
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2011年 8月 15日

FDA Draft Guidance Identifies Benefit-Risk Factors Used for Premarket Reviews

The US Food and Drug Administration has published draft guidance on the factors agency reviewers use to make benefit-risk decisions for premarket approval (PMA) medical device applications. In making these factors public, the regulator hopes to improve predictability, consistency and transparency of its PMA process (as well as some 510(k) reviews).
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2011年 8月 3日

FDA Modifies List of Standards Used in Premarket Reviews

The US Food and Drug Administration has announced changes to its recognized consensus standards used in
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2011年 8月 2日

FDA Plans Reduced Medical Device User Fees for 2012

The US Food and Drug Administration will reduce medical device user fee rates for its 2012 fiscal year, due to $9.5 million in excess appropriations from 2011. The new rates have been published as US legislators and industry lobbying groups are aggressively questioning FDA arguments for fee increases when the Medical Device User Fee and Modernization Act comes up for renewal next year.
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2011年 7月 29日

IOM Report: Scrap 510(k) Process

A highly anticipated report by the Institute of Medicine of the National Academies (IOM) has...
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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)...
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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.)
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