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Medical Device Sector News

K&L Gates: FTC Rules that “Randomized Clinical Trial” Evidence is Necessary to Support Advertising Claims for Juice Beverage and Related Products

May 16, 2013 Clinical Trials

Greenberg Traurig: CMS Issues Final "Sunshine" Rule, Establishing New Reporting Requirements for Drug and Device Makers and Some GPOs

May 13, 2013 Health Care Reform & Physician Payment Sunshine Act

Holland & Knight: Controversial U.S. Medical Study Raises Informed Consent Questions

May 09, 2013 Clinical Trials

FDA Guidance on Mobile Apps

Covington & Burling: Rethinking the FDA’s Regulation of Mobile Medical Apps

EpsteinBeckerGreen: Mobile Medical Apps Guidance: What's Good for the US Is Good for the EU

Fish & Richardson: New FDA Draft Guidance Sheds Light On Regulation of ‘Mobile Medical Apps’ and Other Software

Health Care Reform & Medical Device Sector

Pepper Hamilton: FDA Guidance Regarding Factors to Consider When Making Benefit-Risk Determinations in Medical Device Premarket Approval and De Novo Classifications

EpsteinBeckerGreen: Medicare Providers and Suppliers Continue in the Spotlight

EpsteinBeckerGreen: PPACA Amends Rehabilitation Act to Mandate Standards for Medical Diagnostic Equipment to Accommodate Individuals with Disabilities

FDA Draft Guidance on In Vitro Companion Diagnostic Devices

Hogan Lovells: FDA issues draft guidance regarding in vitro companion diagnostic devices, an area of device regulation marked by ambiguity

Sidley Austin: New Draft Guidance on Companion Diagnostics Signals New Responsibilities for Pharma and Dx Companies and Clinical Laboratories

Mintz Levin: FDA Draft Guidance on In Vitro Companion Diagnostic Devices Provides an Outline but Few Specifics to Advance the Growth of Personalized Medicine

Clinical Trials

K&L Gates: FTC Rules that “Randomized Clinical Trial” Evidence is Necessary to Support Advertising Claims for Juice Beverage and Related Products

Holland & Knight: Controversial U.S. Medical Study Raises Informed Consent Questions

Sidley Austin: Draft Guidance on Dual Function Molecular Diagnostic Instruments Could Broaden FDA Reach into Non-Devices

FDA's 510(k) Pathway

Covington & Burling: D.C. District Court Rules FDA Has Inherent Authority to Rescind 510(k) Clearance in "Rare Situation"

Barnes & Thornburg: FDA Issues Final Guidance on Refuse to Accept Policy for 510(k)s and PMAs

McGuireWoods: FDA Introduces New 510(k) Refuse to Accept Policy

Arent Fox: Be Prepared the Next Time NSC Knocks on Your Door

Bass Berry Sims: Double-Take on DMEPOS: CMS Relaxes Supplier Standards

EpsteinBeckerGreen: CMS Issues Final Rule Modifying Restrictions on "Direct Solicitation" of Beneficiaries by DMEPOS Suppliers; Changes to Other DMEPOS Supplier Safeguards

FDA's Medical Device Data Systems (“MDDS”) Rule

Holland & Knight: Hospital Systems May Be Regulated as Medical Device Manufacturers Under FDA's New MDDS Final Rule

K&L Gates: Registration and Listing Deadline Quickly Approaching for Manufacturers of Medical Device Data Systems

ReedSmith: Three Years Later, FDA Finalizes Medical Device Data Systems (“MDDS”) Rule

Parallel Review of Medical Products?

Sidley Austin: FDA and CMS Announce Beginning of Parallel Review Pilot Program for Medical Devices

Barnes & Thornburg: FDA & CMS Launch Pilot Program for Parallel Review of Medical Devices

Holland & Knight: FDA and CMS Take First Step to Establish Parallel Review

Medical Device Excise Tax

Arent Fox: New Year, New Tax on Medical Devices

Cooley: Medical Device Excise Tax Goes Into Effect Despite Opposition

Akerman: Medical Devices To Be Taxed: Manufacturers and Importers Be Prepared

Pharma & Device Sectors Face FCPA Scrutiny

Arnold & Porter: Pfizer's FCPA Settlement Provides Important Lessons for the Medical Products Industry on Compliance Program Expectations

Vinson & Elkins: A Prescription for Trouble: Pfizer Hit with FCPA Charges as Focus on Foreign Corruption in the Pharmaceutical Industry Continues

Fulbright & Jaworski: Orthofix Makes Latest Medical Device FCPA Settlement

Matrixx v Siracusano & Disclosure/Materiality of Adverse Event Reports

McCarter & English: Matrixx and Recent Lower Court Decisions

Pepper Hamilton: Lower Courts Follow Matrixx's Guidance on Motions to Dismiss

Akin Gump: Supreme Court Gives Guidance On Materiality Standard

Health Care Reform & Stark Law

Arent Fox: Intermountain Healthcare Settlement of $25.5 Million Stems from Stark Law Violations

Greenberg Traurig: Stark Law Violations Costly To Intermountain Health Care Inc.

Jackson Walker: Closure of Stark Whole Hospital Exception Survives Court Challenge

Health Care Reform & Physician Payment Sunshine Act

Greenberg Traurig: CMS Issues Final "Sunshine" Rule, Establishing New Reporting Requirements for Drug and Device Makers and Some GPOs

Paul Hastings: CMS Issues Final Rule Interpreting The Physician Payment Sunshine Act

Fulbright & Jaworski: The Other Side of the Sunshine Act: Reporting Ownership & Investment Interests

Health Care Reform & Therapeutic Discovery Tax Credit

Nixon Peabody: New tax credit or cash grant for qualifying therapeutic discovery projects

Sidley Austin: IRS Releases Application Form for Section 48D Tax Credits and Grants for Qualifying Therapeutic Discovery Projects

Kilpatrick Stockton: IRS Commences Therapeutic Discovery Project Credit Application Process