2011年 9月 14日

FDA Mobile Apps Workshop: Panelists Grapple with Apps-as-Accessories Issue

During the US Food and Drug Administration’s two-day public workshop on its Mobile Medical Applications Draft Guidance held September 12 and 13, 2011, attendees and FDA officials wrestled with the issue of how to classify applications that serve as accessories to medical devices.
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2011年 9月 9日

CDRH Issues Additional Import Entry Review Process Recommendations

The US FDA’s Center for Devices and Radiological Health (CDRH) has issued an Letter to...
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2011年 9月 2日

New Manufacturer Evaluation Codes in Place at FDA

New Manufacturer Evaluation Codes for use in medical device reports have been established by the US Food and Drug Administration’s Center for Devices and Radiological Health (CDRH).
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2011年 9月 1日

FDA: PMA Requirements for Surgical Mesh Devices Possible

The US Food and Drug Administration appears likely to require premarket assessments rather than premarket notifications for surgical mesh devices used to treat pelvic organ prolapse (POP) but not for stress urinary incontinence (SUI) in women.
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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New draft guidance from the US Food and Drug Administration recommends compliance pathways for medical device manufacturers regarding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FDA Draft Guidance Identifies Benefit-Risk Factors Used for Premarket Reviews

The US Food and Drug Administration has published draft guidance on the factors agency reviewers use to make benefit-risk decisions for premarket approval (PMA) medical device applications.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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