By Jennifer D. Newberger & Jeffrey N. Gibbs – In the draft MDR guidance discussed in our prior post, FDA stated that it has not yet issued a Federal Register notice required by the Food and Drug Administration Amendments Act of 2007 (“FDAAA”) regarding certain …
By Kurt R. Karst – “… — …” – That’s the international Morse code distress signal commonly shown as SOS. SOS is also in the title of the acronymized “FDA SOS Act,” or the “FDA Safety Over Sequestration Act,” which a bipartisan group of members …
By Joseph W. Cormier – Last week, the Administrative Conference of the United States ("ACUS") made four recommendations to the Executive Branch and independent agencies, three of which may be of interest to readers of this blog. Among its first recommendations this year, the ACUS …
By Jennifer D. Newberger – At long last, 16 years after the most recent version, FDA has issued a new draft guidance about medical device reporting for manufacturers. Companies have long complained about the ambiguities in the regulation. In a typical case of “be careful what …
By Kurt R. Karst – It was 75 years ago today, on June 25, 1938, that President Franklin Delano Roosevelt signed into law the Federal Food, Drug, and Cosmetic Act (“FDC Act”), which replaced the Pure Food and Drug Act of 1906, 34 Stat. 768, …
By Jennifer D. Newberger – On June 14, 2013, FDA issued a draft guidance, “FDA Decisions for Investigational Device Exemption (IDE) Clinical Investigations,” to provide clarity around certain IDE decisions, and to introduce a “voluntary program intended to facilitate the development of trial designs that may …
By Kurt R. Karst – A Draft Committee Report made available by the U.S. House of Representatives Committee on Appropriations that would, once finalized, accompany the Fiscal Year 2014 Agriculture/FDA Apprropriations bill (currently available as a Full Committee Draft), lays out a laundry list of …
By Jeffrey N. Gibbs, Jamie K. Wolszon & Jessica A. Ritsick – For many years, FDA has wrestled with how to regulate Laboratory-Developed Tests (“LDTs”). FDA Commissioner Margaret A. Hamburg is now renewing FDA’s call for more active FDA regulation of LDTs and touting the …
By Jeffrey K. Shapiro – The Medical Device Amendments of 1976 (“MDA”), Pub. L. No. 94-295, 90 Stat. 539 (1976), are commonly described as the beginning of the modern era of device regulation. In one sense, this description is absolutely correct. The MDA established for …
By Carmelina G. Allis – FDA has issued an “It Has Come to Our Attention Letter” to Biosense Technologies Private Limited for failure to have a 510(k) clearance for its mobile app, the uChek Urine Analyzer. The app can be downloaded for 99 cents through …
By Jeffrey K. Shapiro & Jennifer D. Newberger – As discussed in our prior posts (here, here, and here), the Center for Devices and Radiological Health (“CDRH”) has taken much needed steps to improve the most commonly used appeal process, request for supervisory review, available …
By Jennifer D. Newberger – In the Federal Register of May 8, 2013, FDA announced a public meeting titled “510(k) Device Modifications: Deciding When to Submit a 510(k) for a Change to an Existing Device.” The notice states that the focus of the meeting will be …
On May 4, 2013, Hyman, Phelps & McNamara, P.C. Director Jeffrey K. Shapiro presented a draft paper and slides on the 510(k) medical device substantial equivalence program during a conference on FDA in the 21st Century. The conference was held at the Harvard Law School’s …
By Carmelina G. Allis – As we previously reported, ReGen Biologics, Inc. ("ReGen"), which has been acquired by Ivy Sports Medicine, LLC ("Ivy"), filed suit in 2011 challenging FDA’s authority to rescind the 2008 510(k) substantial equivalence determination for the company’s “Menaflex” product, a collagen …
The Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School is is holding its annual conference on Friday and Saturday, May 3-4, 2013, at Harvard Law School in Cambridge, Massachusetts. This year, the conference will focus on FDA and is titled …
