Search Results for:
Jeffrey K Shapiro
(18)
ARTICLES(18)
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FDA Issues New Draft Guidance for Custom Devices; Some Points Worth Highlighting
- January 31, 2014
- LEGAL ALERTS/ARTICLES
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Free the FDAAA Hostage!
- October 08, 2013
- LEGAL ALERTS/ARTICLES
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Mobile Medical Applications: A Thoughtful Guidance Is Finalized
- September 27, 2013
- LEGAL ALERTS/ARTICLES
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Is the Malfunction MDR Reporting Requirement Unconstitutional?
- September 12, 2013
- LEGAL ALERTS/ARTICLES
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The Medical Device Amendments of 1976: The Statute That Went Awry
- June 05, 2013
- LEGAL ALERTS/ARTICLES
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CDRH Issues Final Appeals Guidance, Q&A About FDASIA Appeals Process
- May 23, 2013
- LEGAL ALERTS/ARTICLES
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CDRH Working to Update Appeals Guidance for Consistency with FDASIA
- April 22, 2013
- LEGAL ALERTS/ARTICLES
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Cytori Case Decision Upholds FDA’s Not Substantially Equivalent Determination
- March 27, 2013
- LEGAL ALERTS/ARTICLES
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First Fruits of FDASIA’s New Device Reclassification Procedure
- February 18, 2013
- LEGAL ALERTS/ARTICLES
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FDA Ramps Up Focus on Advertising of Restricted Devices to Consumers
- January 09, 2013
- LEGAL ALERTS/ARTICLES
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A Difference of Opinion: CDRH’s SOP for Internal Supervisory Appeals
- October 09, 2012
- LEGAL ALERTS/ARTICLES
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FDA’s Voluntary ISO Audit Submission Program
- October 02, 2012
- LEGAL ALERTS/ARTICLES
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FDA Should Be Required To Provide 510(k) Decision Summaries
- June 19, 2012
- LEGAL ALERTS/ARTICLES
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FDA’s Brief in Par: The Gift that Keeps on Giving
- March 13, 2012
- LEGAL ALERTS/ARTICLES
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MDR Reporting - FDA Appears to Disavow The Two Year Presumption
- February 15, 2012
- LEGAL ALERTS/ARTICLES
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FDA Issues Draft Guidance on Medical Device Appeals Processes
- January 09, 2012
- LEGAL ALERTS/ARTICLES
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Examination of MDR Reporting Criteria Warranted in Light of Recent Warning Letter
- December 01, 2011
- LEGAL ALERTS/ARTICLES
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Appealing Premarket Disputes in the Device Center: Reform Is Needed
- October 11, 2011
- LEGAL ALERTS/ARTICLES