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 …
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in which the Center for Devices and Radiological Health ("CDRH") issued what appeared to be an unprecedented number of draft guidance documents, CDRH issued two more on December 27, 2011.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 …
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 …
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, …
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 …
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 …
By Jennifer D. Newberger – On Tuesday, November 15th, Senator Al Franken (D-MN) announced the introduction of S. 1865, the “Patient Access to Medical Innovation Act.” The bill is intended to accomplish two goals: first, to allow manufacturers of products granted a humanitarian device exemption ("HDE") to profit …
By Carmelina G. Allis – A persistent industry complaint is that CDRH too often changes data requirements in the middle of a review, or requires data for a new device that was not required for predicate devices. It appears that CDRH has taken a step toward addressing …
By Jennifer D. Newberger – On October 31, 2011, FDA issued a report titled “Understanding Barriers to Medical Device Quality.” The report results from an initiative launched by the Center for Devices and Radiological Health (“CDRH”) “to assess and understand gaps in medical device quality.” The …
By Kurt R. Karst – Earlier this week, the U.S. Senate passed, by a 69-30 vote, H.R. 2112, the Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2012, as part of an omnibus package of three spending measures. The House and Senate …
By Carmelina G. Allis – A billhas been introduced in the U.S. Senate, the “Medical Device Regulatory Improvement Act” (S. 1700) to amend the least burdensome and conflicts of interest provisions in Sections 513 and 712 of the Federal Food, Drug, and Cosmetic Act (the Act), respectively, …
By Jennifer D. Newberger – On October 14, 2011, Representative Brian Bilbray (R-CA) introduced H.R. 3203, the “Novel Device Regulatory Relief Act of 2011.” This bill intends to amend section 513(f) of the Federal Food, Drug, and Cosmetic Act (“FDC Act”) to expedite the process for …
By Jeffrey K. Shapiro – A medical device manufacturer in most cases is legally required to obtain 510(k) clearance or premarket application (“PMA”) approval from the Food and Drug Administration’s (“FDA”) prior to commercial distribution. Premarket reviews are conducted under the auspices of the Office of …
