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  • Medical Devices

    • FDA Denies Washington Legal Foundation Citizen PetitionFebruary 27th, 2012

      By Jennifer D. Newberger – In September 2009, FDA engaged IOM, a member of the National Academy of Sciences ("the Academy"), to review the 510(k) medical device premarket review process and answer the following questions: (1) Does the current 510(k) clearance process protect patients optimally and promote …

    • Hyman, Phelps & McNamara, P.C. Submits Supplemental Comments to FDA to Highlight FDA Description of RUO Guidance in Par BriefFebruary 23rd, 2012

      By Jamie K. Wolszon & Jeffrey N. Gibbs –   On February 15, 2012, Hyman, Phelps & McNamara, P.C. (“HPM”) submitted supplemental comments to FDA’s June 1, 2011 draft guidance (see our previous post here) that would limit the sale and distribution of Research Use Only (“RUO”) products.  HPM’s …

    • MDR Reporting – FDA Appears to Disavow The Two Year PresumptionFebruary 14th, 2012

      By Jeffrey K. Shapiro – This post is the second in an occasional series that will examine significant or interesting warning letters involving medical device companies.  As a reminder, FDA issues warning letters to allege violations of the Federal Food, Drug, and Cosmetic Act and/or implementing regulations.  …

    • Reps. Rogers and Markey Introduce Bill to Implement Withdrawn Pediatric Medical Device RuleFebruary 10th, 2012

      By Jennifer D. Newberger – On Wednesday, February 8, Representatives Mike Rogers (R-MI) and Ed Markey (D-MA) introduced H.R. 3975, The Pediatric Medical Device Safety and Improvement Reauthorization Act of 2012.  The bill would put into effect a rule previously withdrawn by FDA regarding the inclusion of pediatric information …

    • Senators Casey and McCain Introduce Bill to Streamline De Novo Process and Reclassify Preamendment DevicesFebruary 6th, 2012

      By Jennifer D. Newberger – On Thursday, February 2, Senators Bob Casey (D-PA) and John McCain (R-AZ) introduced S. 2067, titled the “Safe, Efficient, and Transparent Medical Device Approval Act” or the “SET Device Act.”  The bill would require FDA to reclassify preamendment Class III devices …

    • A Solution in Search of a Problem: Safety of Untested and New Devices Act of 2012February 1st, 2012

      By Jennifer D. Newberger – On January 31, 2012, Rep. Edward Markey (D-MA) introduced H.R. 3847, the “Safety of Untested and New Devices Act of 2012,” also known as the “SOUND Devices Act of 2012.”  The bill attempts to limit the body of devices that may …

    • CDRH Issues its Strategic Priorities for 2012January 29th, 2012

      By Jennifer D. Newberger – On Tuesday, January 24, FDA’s Center for Devices and Radiological Health (“CDRH”) released its strategic priorities for 2012:  (1) fully implement a total life cycle approach; (2) enhance communication and transparency; (3) strengthen the CDRH workforce and workplace; and (4) proactively …

    • HP&M to Host Webinar on the FDA Appeals ProcessJanuary 19th, 2012

      Pharmaceutical and medical device applicants faced with an adverse decision from FDA (e.g., regarding data requirements, study design, or regulatory pathway) may dispute that decision through multiple routes.  The appeal processes in both CDER and CDRH offer numerous strategic and procedural advantages that, when used …

    • FDA Issues Draft Guidance on Medical Device Appeals ProcessesJanuary 5th, 2012

      By Jeffrey K. Shapiro, Jeffrey N. Gibbs & Jennifer D. Newberger – It is essential to FDA’s proper functioning that stakeholders have a viable appeals process.  This means a process that is timely, transparent, and fair.  A viable appeals process is an essential “check and balance” …

    • D.C. Circuit Affirms Dismissal of Holistic Candler’s Lawsuit and Tosses Out the Whole Ball of WaxJanuary 5th, 2012

      By Susan J. Matthees – Earlier this week, the U.S. Court of Appeals for the District of Columbia Circuit affirmed the U.S. District Court for the District of Columbia’s decision granting FDA’s Motion to Dismiss a lawsuit filed in April 2010 by a group of ear …

    • CDRH Issues Draft Guidance on Substantial Equivalence DeterminationsDecember 29th, 2011

      By Jennifer D. Newberger – To finish out a year in which the Center for Devices and Radiological Health ("CDRH") issued what appeared to be an unprecedented number of draft guidance documents, CDRH issued two more on December 27, 2011.  This blog post discusses one such …

    • GAO Reports on Approval of Pediatric Medical DevicesDecember 22nd, 2011

      By Jennifer D. Newberger – The Government Accountability Office (“GAO”) recently issued a report on pediatric device development.  The report “(1) describes barriers to developing pediatric devices, (2) describes how pediatric device consortia have contributed to the development of pediatric devices, and (3) examines FDA data …

    • Medical Device Patient Safety Act Introduced in the Senate; Bill Would Allow for Recall Tracking and Conditional ClearancesDecember 18th, 2011

      By Jennifer D. Newberger – On Thursday, December 15, 2011, Senators Chuck Grassley (R-Iowa), Richard Blumenthal (D-Conn.), and Herb Kohl (D-Wis.) introduced the “Medical Device Patient Safety Act.”  This bill contains two distinct proposals:  (1) to give FDA the authority to track and trend device recalls, …

    • Senator Brown Proposes Modifications to the De Novo ProcessDecember 6th, 2011

      By Jennifer D. Newberger – On December 5, 2011, Senator Scott Brown (R-MA) introduced S. 1943, the “Novel Device Regulatory Relief Act of 2011.”  The bill is intended to amend section 513 of the Federal Food, Drug, and Cosmetic Act (“FDC Act”) to expedite the process …

    • Examination of MDR Reporting Criteria Warranted in Light of Recent Warning LetterNovember 29th, 2011

      By Jeffrey K. Shapiro – In our continuing quest to enlighten, we are launching today an occasional series that will examine significant or interesting warning letters involving medical device companies. As you probably know, FDA issues warning letters to allege violations of the Federal Food, Drug, and …