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  • Medical Devices

    • FDA Seeks Comments on Custom DevicesNovember 20th, 2012

      By Jennifer D. Newberger – Section 520(b) of the Federal Food, Drug, and Cosmetic Act ("FDC Act") exempts “custom devices” from the performance standards or premarket approval ("PMA") requirements of sections 514 or 515 if certain criteria are met.  The Food and Drug Administration Safety and …

    • FDA Amends UDI Proposed Rule to Comply with FDASIA RequirementsNovember 19th, 2012

      By Jennifer D. Newberger – FDA is amending its proposed rule to establish a unique device identification (“UDI”) system, published on July 10, 2012 (see our previous post here), to meet the requirements of section 614 of the Food and Drug Administration Safety and Innovation Act …

    • CDRH Reorganizes its Office of Device EvaluationNovember 7th, 2012

      By Jennifer D. Newberger – CDRH recently announced that, as of November 1, 2012, the Office of Device Evaluation ("ODE") has been reorganized.  There are two new divisions—the Division of Surgical Devices and the Division of Neurological and Physical Medicine Devices—and 12 new branches across all …

    • FDA Issues Draft Guidance Regarding the New Electronic Copy (eCopy) Program for Device SubmissionsOctober 25th, 2012

      By Carmelina G. Allis – FDA has issued a draft guidance document to explain how FDA plans to implement the new eCopy program under Section 745A(b) of the Federal Food, Drug, and Cosmetic Act (“FDC Act”), which was added by the Food and Drug Administration …

    • A Difference of Opinion: CDRH’s SOP for Internal Supervisory AppealsOctober 8th, 2012

      By Jeffrey K. Shapiro & Jessica A. Ritsick – Under FDA’s regulations (10 C.F.R. § 10.75), the decision of an FDA employee (other than the Commissioner) is subject to supervisory review in four circumstances: (1) when an employee so requests; (2) when a supervisor initiates review; …

    • Who Should Regulate Medical Mobile Apps? FDA or Some Other HHS Agency?October 4th, 2012

      By Carmelina G. Allis – Should FDA’s Center for Devices and Radiological Health (“CDRH”) regulate medical mobile apps?  Or should medical mobile apps be regulated by another office within FDA? Or should they be regulated by a separate entity under the Department of Health and …

    • GAO Report on Potential Information Security Risks for Certain DevicesOctober 1st, 2012

      By Jennifer D. Newberger – The Government Accountability Office (“GAO”) recently issued a report titled, “Medical Devices: FDA Should Expand Its Consideration of Information Security for Certain Types of Devices.”  The report was intended to examine how FDA protects active implantable devices against information security risks that …

    • FDA’s Voluntary ISO Audit Submission ProgramSeptember 30th, 2012

      By Jeffrey K. Shapiro & Jessica A. Ritsick – ISO 13485 (2003) is an internationally recognized management system for the design and manufacture of medical devices.  Most device manufacturers have quality systems intended to comply with ISO 13485.  FDA has finally implemented a 2007 statutory …

    • Is it a Drug or Device? Court Requires FDA to Explain ItselfSeptember 26th, 2012

      By Jennifer M. Thomas & Anne K. Walsh –   Yesterday, in a big win for industry, District Court Judge Rosemary Collyer granted French company PREVOR’s Motion for Summary Judgment in a case challenging FDA’s decision to regulate PREVOR’s Diphoterine® Skin Wash (“DSW”) product as a …

    • Insight into FDA’s Implementation of FDASIA for DevicesSeptember 25th, 2012

      By Jennifer D. Newberger – On Thursday, September 20, the Food and Drug Law Institute (“FDLI”) and the Drug Information Association (“DIA”) co-sponsored a program titled “Unwrapping FDA’s UFA Package:  What’s Inside the Statute – What’s Next?”  The program discussed many aspects of the recently passed …

    • The Whole Ball of Wax: FDA Says Supreme Court Review of Holistic Candlers Case is Not WarrantedSeptember 18th, 2012

      By Kurt R. Karst & JP Ellison –      The U.S. Solicitor General filed a brief last week urging the U.S. Supreme Court not to grant a Petition for Writ of Certiorari filed earlier this year by a group of ear candle advocates after the U.S. …

    • CDRH Seeks to Enhance Postmarket Surveillance SystemsSeptember 11th, 2012

      By Jennifer D. Newberger – On September 6, FDA released a white paper titled “Strengthening Our National System for Medical Device Postmarket Surveillance.”  This paper stems at least in part from the recommendation by the Institute of Medicine for FDA to “develop and implement a …

    • If You are A Mobile App Developer, Get it Right from the Start, Please!September 9th, 2012

      By Carmelina G. Allis – If you are a mobile app developer, be sure to review the FTC’s newly published guidelines on truth-in-advertising and privacy principles, “Marketing Your Mobile App, Get it Right from the Start.”  They apply to you, whether you are a start-up …

    • IOM Issues Report on “Accelerating the Development of New Drugs and Diagnostics: Maximizing the Impact of the Cures Acceleration Network”August 27th, 2012

      By Alexander J. Varond – The Institute of Medicine (“IOM”) recently issued a paper titled “Accelerating the Development of New Drugs and Diagnostics: Maximizing the Impact of the Cures Acceleration Network: Workshop Summary.” The IOM paper summarizes the “Maximizing the Goals of the Cures Acceleration Network to …

    • The Rabbit Hole Runs Deep; CDRH “Whistleblower” Scandal Involves a Once-Secret qui tam LawsuitAugust 26th, 2012

      By James R. Phelps – According to recent reports concerning the widely reported “whistleblower” scandal at FDA’s Center for Devices and Radiological Health (“CDRH”), in 2009, the CDRH dissidents involved in the affair, while still employed at FDA, filed a “secret” Federal False Claims Act suit …