By Carmelina G. Allis – Since September 2009, the Center for Devices and Radiological Health (“CDRH”) has been reviewing the operation of the 510(k) program and the way CDRH uses science in the decision making process. This week, the 510(k) Working Group and the Task …
On August 4, 2010, the Food and Drug Law Institute (“FDLI”) will host a webinar, titled “FDA’s (Emerging) Oversight of Laboratory-Developed Tests.” Hyman, Phelps & McNamara, P.C.’s Jeffrey N. Gibbs will moderate the webinar and a panel of speakers that includes FDA’s Elizabeth A. Mansfield, …
By Jamie K. Wolszon & Jeffrey N. Gibbs – FDA officials, at a July 19-20, 2010 workshop, stated that the agency intends to end the “exercise enforcement” authority over some laboratory-developed tests (“LDTs”). Put more plainly, FDA now plans to regulate some LDTs as medical …
By Jamie K. Wolszon – FDA is signaling that it is considering whether to fundamentally reshape how it regulates laboratories and laboratory-developed tests ("LDTs"). LDTs, which are diagnostic tests developed and performed by a laboratory, are widely used. For example, virtually every genetic test is …
By Jeffrey K. Shapiro – On May 3, FDA announced that it has ordered Baxter to recall and destroy an estimated 200,000 Colleague infusion pumps in use, reimburse customers for the “value” of the recalled device, and assist in finding a replacement. The press release …
By Nisha P. Shah – FDA recently issued a white paper revealing that the Agency intends to strengthen its review of medical devices for home use, such as hemodialysis equipment, wound therapy care, intravenous therapy devices, and ventilators, as more hospital patients are being discharged …
By Kurt R. Karst – It seems to be a popular headline these days: “FDA Sued Over [take your pick].” Following the frenetic losartan 180-day litigation – which is still not over, as FDA has filed a petition for panel rehearing and rehearing en banc …
By Jeffrey K. Shapiro – We are beginning to suspect that the new transparency of this Administration is a lot like the old transparency. Or, as The Who sang in We Won’t Get Fooled Again, “meet the new boss / same as the old boss.” The …
By Jeffrey K. Shapiro – In October 2009, the Department of Health and Human Services Office of Inspector General (“OIG”) issued a report entitled, “Adverse Event Reporting for Medical Devices” (“OIG Report”). The OIG’s Report has not received the attention it deserves. The OIG report …
By Alan M. Kirschenbaum & Kurt R. Karst – On March 23, 2010, President Obama signed into law the Patient Protection and Affordable Care Act (“PPACA”) (Pub. L. No. 111-148 ). A companion bill, the Health Care Education Affordability Reconciliation Act of 2010 (H.R. 4872), which …
By Kurt R. Karst – Just one day after FDA Commissioner, Dr. Margaret Hamburg, testified last week before the U.S. Senate Committee on Appropriations, Subcommittee on Agriculture, Rural Development, FDA, and Related Agencies on FDA’s Fiscal Year 2011 budget request, which includes new user fees, …
By Susan J. Matthees – A new preemption decision has just come down from a California appeals court (the sixth circuit appellate district). In two consolidated cases, McGuan v. Endovascular Technologies, Inc., et al. and Johnson v. Endovascular Technologies, Inc., the appeals court upheld a lower …
By Peter M. Jaensch – On January 4, 2010, the Washington Legal Foundation (“WLF”) filed an amicus curiae brief in support of Ortho Biotech Products’ petition for a writ of certiorari in the Supreme Court of the United States, urging review of the decision in …
By Alan M. Kirschenbaum – On January 5, 2010, FDA released a “Guidance for Industry on New Contrast Indication Considerations for Device and Approved Drug and Biological Products.” The primary purpose of the Guidance is to establish a process that allows imaging device manufacturers to …
By Alan M. Kirschenbaum, Kurt R. Karst & J.P. Ellison – On Thursday morning, the U.S. Senate passed, by a 60-39 vote, H.R. 3590, the Patient Protection and Affordable Care Act. Last weekend, Sen. Harry Reid (D-NV) unveiled a 383-page Manager’s Amendment to the bill. …
