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  • Medical Devices

    • Are All Health and Wellness Mobile Apps Exempt from FDA Regulatory Requirements?March 12th, 2013

      By Carmelina G. Allis – With information technology taking on an increasingly important role in the healthcare system, software app developers are focusing their efforts on developing programs intended to facilitate health, wellness, and disease management.  Some of these apps are developed for and implemented …

    • CDRH Issues Joint FDA/FTC Promotion and Advertising Untitled “Email” to On-line Distributors; Uses Unprecedented Approach to Warn of Possible Criminal ProsecutionMarch 7th, 2013

      By Carmelina G. Allis – On February 28, 2013, FDA’s Center for Devices and Radiological Health (“CDRH”) issued what appears to be an unprecedented joint FDA/Federal Trade Commission “untitled letter” in the form of an email (an “untitled email”) to on-line distributors of decorative contact …

    • Medical Device Recall or Product Enhancement? FDA’s New Draft Guidance Should Be Recalled for Significant RepairsFebruary 28th, 2013

      By Jeffrey K. Shapiro –  FDA has just issued a draft guidance document titled “Distinguishing Medical Device Recalls from Product Enhancements and Associated Reporting Requirements” (Docket No. FDA-2013-D-0114) intended to clarify how to distinguish product “corrections” from product “enhancements.”  Although the draft guidance would be applicable …

    • FDA Issues Proposed Rule Affecting Acceptance of Data from Medical Device Clinical StudiesFebruary 25th, 2013

      By Jennifer D. Newberger – FDA issued a proposed rule to amend its regulations on acceptance of data from medical device clinical studies.  The primary proposed changes include: Requiring that clinical studies conducted outside the United States to support any submission to FDA, including a 510(k) or …

    • FDA Issues Draft Guidance, Proposed Rule Regarding Submission of Information on Pediatric Use of Medical DevicesFebruary 24th, 2013

      By Jennifer D. Newberger – The Food and Drug Administration Amendments Act of 2007 (“FDAAA”) amended the Federal Food, Drug, and Cosmetic Act (“FDC Act”) to require certain medical device submissions to include, “if readily available – (A) a description of any pediatric subpopulations that suffer …

    • FTC’s Interest in Mobile Apps IntensifiesFebruary 22nd, 2013

      By Carmelina G. Allis – As reported in FTC Watch Issue No. 823 (Feb. 13, 2013), the Federal Trade Commission has plans to increase enforcement actions against mobile apps – including mobile medical apps. During a Consumer Protection Conference sponsored by the American Bar Association earlier …

    • First Fruits of FDASIA’s New Device Reclassification ProcedureFebruary 17th, 2013

      By Jeffrey K. Shapiro – We are seeing the first fruits of a new device reclassification procedure added last summer to the Federal Food, Drug, and Cosmetic Act (“FDCA”).  The new procedure modifies Section 513(e) of the FDCA to make it easier for FDA to reclassify …

    • Caronia Webinar – Slides and Audio Available for DownloadFebruary 8th, 2013

      On January 31, 2013, Hyman, Phelps & McNamara, P.C. presented a webinar addressing the real-world implications from the Second Circuit decision in United States v. Caronia.  Panelists addressed the potential impacts to the pharmaceutical, devices, dietary supplements, and tobacco industries.  HP&M was quite pleased that …

    • FDA Finalizes Guidance on Humanitarian Use Device DesignationsJanuary 29th, 2013

      By Jennifer D. Newberger – On January 24, 2013, FDA finalized the Humanitarian Use Device (HUD) Designations guidance, issued in draft on December 13, 2011.  The guidance addresses HUD requests, a first step in obtaining approval of a Humanitarian Device Exemption (HDE).  A HUD is a …

    • FDA Issues Final Rule on CGMP Requirements for Combination Products; Requirements for “Convenience Kits” DefinedJanuary 24th, 2013

      By Carmelina G. Allis – The FDA has issued a final rule on the current good manufacturing practice (CGMP) requirements applicable to combination products.  78 Fed. Reg. 4307 (Jan. 22, 2013).  This rule finalizes a proposed rule issued on September 23, 2009.  The new rule, …

    • Real-World Implications of United States v. Caronia – A Hyman, Phelps & McNamara, P.C. WebinarJanuary 10th, 2013

      Hyman, Phelps & McNamara, P.C. will hold a complimentary webinar on Thursday, January 31, 2013, from 12:00 – 2:00 PM (Eastern) on the Second Circuit's recent and long-awaited decision in United States v. Caronia.  This webinar is not just another summary of the Second Circuit's decision. Nor …

    • FDA Ramps Up Focus on Advertising of Restricted Devices to ConsumersJanuary 7th, 2013

      By Jeffrey K. Shapiro – FDA has enhanced authority over the sale, distribution and use of devices that the agency designates as “restricted.”  21 U.S.C. § 360j(e).  FDA almost always designates Class III devices as “restricted devices” in premarket application (“PMA”) approval orders.  21 U.S.C. …

    • CDRH Releases Three Final Guidance DocumentsJanuary 3rd, 2013

      By Jennifer D. Newberger – On December 31, 2012, CDRH released three final guidance documents, the drafts of which were issued in the summer and fall of 2012.  The quick finalization of these guidance documents is likely due to their fairly uncontroversial nature, since they are …

    • Your Dog as a Medical Device?December 26th, 2012

      By Jennifer D. Newberger & Jeffrey N. Gibbs – A quick Google search of “dog trained to identify medical conditions” indicates that, around the world, dogs are already working with people to help sniff out certain medical conditions.  For example, in the United Kingdom an organization …

    • Support Appears to be Growing to Delay the Medical Device TaxDecember 13th, 2012

      By Carmelina G. Allis – Earlier this month, the IRS published final regulations and interim guidance on the excise tax imposed on the sale of certain medical devices intended for human use pursuant to the Health Care and Education Reconciliation Act of 2010 and the Patient Protection …