By Carmelina G. Allis – In a report released last week, the U.S. Government Accountability Office (“GAO”) provides the results from a study it conducted to determine whether FDA has met timeframe performance goals related to the completion of reviews for premarket notification (510(k)) submissions and …
By Jennifer D. Newberger – On March 27, 2012, FDA announced the release of a final guidance document, “Factors to Consider When Making Benefit-Risk Determination in Medical Device Premarket Approval and De Novo Classifications.” (A copy of FDA's March 28, 2012 Federal Register notice announcing the …
By Carmelina G. Allis – Amid recent reports alleging safety and effectiveness issues with a number of implant devices, a bipartisan group of Senators have introduced a bill entitled the “Ensuring Safe Medical Devices for Patients” (S. 2193). This bill is intended to strengthen FDA’s postmarket surveillance …
By Jennifer D. Newberger – On March 20, 2012, FDA published a notice in the Federal Register announcing a public meeting to discuss proposed recommendations (here and here) for the reauthorization of the Medical Device User Fee Act (“MDUFA”) for fiscal years 2013 through 2017. 77 …
By Jeffrey K. Shapiro – We previously discussed the government’s brief in the Par case in the context of what it says about FDA’s draft Research Use Only guidance. However, the government’s brief in Par is worth examining from another angle. (Note: the Par case involves …
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 …
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– On February 15, 2012, Hyman, Phelps & McNamara, P.C. (“HPM”) submitted supplemental comments to FDA’s June 1, 2011 draft guidance (see our previous post here) that would limit the sale and distribution of Research Use Only (“RUO”) products.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 …
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. …
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 …
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 …
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 …
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 …
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 …
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” …
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 …
