Publications

Searched Practice: Medical Devices & Diagnostics

"CFDA Publishes Draft Rule on Administrative Procedure for Public Comment," Covington E-Alert (8/28/2013)
Shaoyu Chen Co-Author, Scott Cunningham Co-Author, John Balzano Co-Author, Mingham Ji Co-Author

"Recalls of FDA-Regulated Products - What You Need to Know," Covington E-Alert (8/19/2013)
Miriam Guggenheim Co-Author, Marialuisa Gallozzi Co-Author, Suzan Charlton Co-Author, Christopher Pruitt Co-Author

"Summary of FDA Advertising and Promotion Enforcement Activities - July 2013," Covington E-Alert (8/12/2013)
Michael Labson Co-Author, Scott Danzis Co-Author, Saurabh Anand Co-Author

"Regulation of Mobile Medical Applications in the USA and the EU," Journal of Medical Device Regulation (August 2013)
Christopher Pruitt Co-Author, Brian Kelly Co-Author

"Summary of FDA Advertising and Promotion Enforcement Activities - June 2013," Covington E-Alert (7/31/2013)
Michael Labson Co-Author, Scott Danzis Co-Author, Saurabh Anand Co-Author

"Sunshine Act Data Collection to Begin August 1," Covington E-Alert (7/30/2013)
Stefanie Doebler Co-Author, Anna Kraus Co-Author, Scott Danzis Co-Author, Ellen Flannery Co-Author

"Summary of FDA Advertising and Promotion Enforcement Activities - May 2013," Covington E-Alert (6/27/2013)
Michael Labson Co-Author, Scott Danzis Co-Author

"Summary of FDA Advertising and Promotion Enforcement Activities - April 2013," Covington E-Alert (5/30/2013)
Michael Labson Co-Author, Scott Danzis Co-Author

"D.C. District Court Rules FDA Has Inherent Authority to Rescind 510(k) Clearance in "Rare Situation"," Covington E-Alert (4/26/2013)
Ellen Flannery Co-Author, Scott Danzis Co-Author, Krista Carver Co-Author, Jennifer Schwartz Co-Author

"Summary of FDA Advertising and Promotion Enforcement Activities - March 2013," Covington E-Alert (4/15/2013)
Michael Labson Co-Author, Scott Danzis Co-Author, Saurabh Anand Co-Author

"CFDA Issues Proposed Regulations on Medical Devices," Covington E-Alert (4/9/2013)
Shaoyu Chen Co-Author, Nan Lou Co-Author, Ellen Flannery Co-Author, Scott Danzis Co-Author

"Summary of FDA Advertising and Promotion Enforcement Activities - February 2013," Covington E-Alert (3/28/2013)
Michael Labson Co-Author, Scott Danzis Co-Author, Julia Post Co-Author

"China Reorganizes the SFDA and Appoints a New Commissioner," Covington E-Alert (3/25/2013)
Shaoyu Chen Co-Author, Ellen Flannery Co-Author, Mingham Ji Co-Author

"2012 End-of-Year Summary of FDA Promotional Enforcement Activity," Covington E-Alert (3/18/2013)
Michael Labson Co-Author, Scott Cunningham Co-Author, Scott Danzis Co-Author, Julia Post Co-Author

"Rethinking the FDA’s Regulation of Mobile Medical Apps," The SciTech Lawyer (Winter/Spring 2013)
Scott Danzis Co-Author, Christopher Pruitt Co-Author

"Summary of FDA Advertising and Promotion Enforcement Activities - January 2013," Covington E-Alert (2/27/2013)
Michael Labson Co-Author, Scott Danzis Co-Author, Julia Post Co-Author

"CMS Issues Final Rule to Implement the Sunshine Act," Covington E-Alert (2/13/2013)
Anna Kraus Co-Author, Stefanie Doebler Co-Author, Meghan Monaghan Co-Author

"Clinical Trial Developments in 2012," Covington E-Alert (2/1/2013)
Scott Cunningham Co-Author, Afia Asamoah Co-Author, Noellyn Davies Co-Author

"Summary of FDA Advertising and Promotion Enforcement Activities - December 2012," Covington E-Alert (1/28/2013)
Michael Labson Co-Author, Scott Danzis Co-Author, Julia Post Co-Author

"Summary of FDA Advertising and Promotion Enforcement Activities - November 2012," Covington E-Alert (12/28/2012)
Michael Labson Co-Author, Scott Danzis Co-Author, Julia Post Co-Author

"Second Circuit Recognizes Significant First Amendment Protections for Off-Label Promotion," Covington E-Alert (12/7/2012)
Scott Cunningham Co-Author, Ellen Flannery Co-Author, Gerald Masoudi Co-Author, Krista Carver Co-Author

"Summary of FDA Advertising and Promotion Enforcement Activities," Covington E-Alert (12/3/2012)
Michael Labson Co-Author, Scott Danzis Co-Author, Julia Post Co-Author

"Summary of FDA Advertising and Promotion Enforcement Activities," Covington E-Alert (10/31/2012)
Michael Labson Co-Author, Scott Danzis Co-Author, Julia Post Co-Author

"France - Changes to Rules for Advertising Medical Devices and IVDs," Covington E-Alert (10/3/2012)
Peter Bogaert Co-Author

"Summary of FDA Advertising and Promotion Enforcement Activities - August 2012," Covington E-Alert (9/28/2012)
Michael Labson Co-Author, Scott Danzis Co-Author, Julia Post Co-Author

"New Medical Devices Regulations in the EU," Covington E-Alert (9/26/2012)
Peter Bogaert Co-Author, Grant Castle Co-Author, Wim van Velzen Co-Author

"What’s in a Name?," European Pharmaceutical Contractor (September 2012)
Peter Bogaert Co-Author, Sarah Cowlishaw Co-Author

"Summary of FDA Advertising and Promotion Enforcement Activities - July 2012," Covington E-Alert (8/31/2012)
Julia Post Co-Author, Michael Labson Co-Author, Scott Danzis Co-Author

"FDA Proposes UDI System for Medical Devices," Journal of Medical Device Regulation (August 2012)
Ellen Flannery Co-Author, Christina Kuhn Co-Author

"Summary of FDA Advertising and Promotion Enforcement Activities - June 2012," Covington E-Alert (7/26/2012)
Julia Post Co-Author, Michael Labson Co-Author, Scott Danzis Co-Author

"FDA Issues Proposed Rule to Establish a Unique Device Identification System for Medical Devices," Covington Advisory (7/16/2012)
Ellen Flannery Co-Author, Scott Danzis Co-Author, Christina Kuhn Co-Author

"Summary of FDA Advertising and Promotion Enforcement Activities - May 2012," Covington E-Alert (6/11/2012)
Michael Labson Co-Author, Scott Danzis Co-Author, Julia Post Co-Author

"FCC Takes Steps to Make More Spectrum Available for Wireless Medical Devices," Covington Advisory (6/7/2012)
Scott Danzis Co-Author, Ellen Flannery Co-Author, Christopher Pruitt Co-Author, Matthew DelNero Co-Author, Lindsey Tonsager Co-Author

"Summary of FDA Advertising and Promotion Enforcement Activities - April 2012," Covington E-Alert (5/29/2012)
Julia Post Co-Author, Michael Labson Co-Author, Scott Danzis Co-Author

"World Health Organization to Discuss Research and Development Treaty," Covington E-Alert (5/8/2012)
Daniel Spiegel Co-Author, Kristen Eichensehr Co-Author

"Summary of FDA Advertising and Promotion Enforcement Activities - March 2012," Covington E-Alert (4/30/2012)
Michael Labson Co-Author, Scott Danzis Co-Author, Julia Post Co-Author

"Supreme Court Delivers Important Decision on Patent Eligibility," Covington E-Alert (3/23/2012)
Natalie Derzko Co-Author, Ellen Flannery Co-Author, Christopher Sipes Co-Author, Andrea Reister Co-Author, Jeffrey Elikan Co-Author, Paul Berman Co-Author

"Summary of FDA Advertising and Promotion Enforcement Activities - February 2012," Covington E-Alert (3/22/2012)
Michael Labson Co-Author, Scott Danzis Co-Author, Julia Post Co-Author

"Summary of FDA Advertising and Promotion Enforcement Activities - January 2012," Covington E-Alert (2/29/2012)
Michael Labson Co-Author, Scott Danzis Co-Author, Julia Post Co-Author

"France - A Revolution for the Medical Devices Industry," Covington E-Alert (2/13/2012)

"FDA Issues Draft Guidance on Evaluating Substantial Equivalence in 510(k) Premarket Notifications," Covington E-Alert (2/7/2012)
Ellen Flannery Co-Author, Krista Carver Co-Author, Christina Kuhn Co-Author

"United States Drug and Device Law - Regulation and Enforcement," Educational Program for Chinese SFDA Officials, New Haven, CT (11/9/2011)
Ellen Flannery

"FDA Issues Draft Guidance on Mobile Medical Applications," Covington E-Alert (8/4/2011)
Scott Danzis Co-Author, Ellen Flannery Co-Author, Christopher Pruitt Co-Author

"FDA Issues Draft Guidance Regarding Research Use Only and Investigational Use Only In Vitro Diagnostic Products," Covington E-Alert (6/13/2011)
Ellen Flannery Co-Author, Scott Danzis Co-Author, Christopher Pruitt Co-Author

"Accountable Care Organization Basics," Covington E-Alert (4/15/2011)
Kevin Shortill Co-Author, Katherine Phillips Co-Author

"CDRH: 510(k)s and Science in Regulatory Decision-Making," Journal of Medical Device Regulation (November 2010)
Ellen Flannery Co-Author, Scott Danzis Co-Author, Christopher Pruitt Co-Author

"FDA's 510(K) Working Group Releases Preliminary Report and Recommendations," Covington E-Alert (8/10/2010)
Ellen Flannery Co-Author, Scott Danzis Co-Author, Christopher Pruitt Co-Author

"FDA Announces Public Meeting to Discuss Plans to Regulate Laboratory Developed Tests as Medical Devices," Covington E-Alert (6/21/2010)
Ellen Flannery Co-Author, Scott Danzis Co-Author

"Health Care Reform: Annual Fee On Prescription Drug Manufacturers And Excise Tax On Medical Device Manufacturers," Covington E-Alert (4/29/2010)
Anna Kraus Co-Author

"FDA Orders Submission of Data Regarding Certain Class III Pre-Amendment Medical Devices," Covington E-Alert (4/13/2009)
Ellen Flannery Co-Author, Scott Danzis Co-Author

"New Rules for Advanced Medical Technologies," Covington E-Alert (4/2/2009)

"Comparative Effectiveness Research Provisions of the American Recovery and Reinvestment Act of 2009," Covington E-Alert (3/6/2009)
Anna Kraus Co-Author

"Draft FDA Guidance on Submission and Expedited Review of Abbreviated Laboratory Packages From Accredited Laboratories," Covington E-Alert (2/23/2009)
Jeannie Perron Co-Author

"FDA Releases Guidance on Voluntary Third-Party Certification Programs for Foods and Feeds," Covington E-Alert (1/26/2009)
Jeannie Perron Co-Author

"FDA Issues Final Guidance on “Good Reprint Practices," Covington E-Alert (1/21/2009)
Scott Danzis Co-Author, Michael Labson Co-Author, Jeannie Perron Co-Author, Peter Safir Co-Author

"Draft Guidance on Good Importer Practices," Covington E-Alert (1/16/2009)
Scott Danzis Co-Author

"AdvaMed Adopts Revised Code of Ethics on Interactions with Health Care Professionals," Covington E-Alert (12/23/2008)
Scott Danzis Co-Author, Ellen Flannery Co-Author

"Product Liability and Reuse of Medical Devices," EURALex (October 2008)
Brian Kelly Co-Author

"REACH and Its Impact on Medical Devices," Covington E-Alert (September 2008)
Cándido García Molyneux Co-Author

"REACH And Its Impact On Medicines And Medical Devices," Covington E-Alert (March 2008)
Cándido García Molyneux Co-Author

"FDA Issues Draft Guidance on the Distribution of Journal Articles and Reference Publications on Unapproved New Uses of Approved or Cleared Medical Products," Covington E-Alert (2/19/2008)
Peter Safir Co-Author, Michael Labson Co-Author

"Food and Drug Administration Amendments Act of 2007," Covington E-Alert (10/2/2007)
Michael Labson Co-Author, Peter Safir Co-Author

"CMS Issues Proposal to Revise Clinical Trial Policy National Coverage Determination," Covington E-Alert (5/3/2007)
Anna Kraus Co-Author, Michael Labson Co-Author, Ellen Flannery Co-Author, Peter Safir Co-Author, Stefanie Doebler Co-Author

"FDA Publishes Proposed Rule on Use of Materials Derived from Cattle in Medical Products Intended for Use in Humans and Drugs Intended for Use in Ruminants," Covington E-Alert (1/19/2007)
Jeannie Perron Co-Author