Medical Devices

By Allyson B. Mullen – Have you ever heard of an “Immediately in Effect (IIE)” guidance document?  Thanks to a new draft SOP issued by CDRH, you may soon see this new species of guidance on a regular basis. In section 405 of Food and Drug …

By Jennifer D. Newberger – At long last, it is here: FDA has issued the final rule implementing the unique device identifier (UDI) requirements, originally required by the Food and Drug Administration Amendments Act of 2007 (FDAAA) and then again by the Food and Drug …

By Allyson B. Mullen – Earlier this summer, CDRH issued a new Draft Guidance for the Content of Premarket Submissions for Management of Cybersecurity in Medical Devices (the “Draft Guidance”).  We have previously posted on the Draft Guidance here.  As noted in our earlier post, …

By Jennifer D. Newberger – The Food and Drug Administration Safety and Innovation Act (“FDASIA”), signed into law in July 2012, requires the Secretary of Health and Human Services (“HHS”) to “post a report—within 18 months (or by January 2014)—that contains a proposed strategy and recommendations …

By Jeffrey K. Shapiro – In 2012, the U.S. Supreme Court held that agency regulations and enforcement policy violate due process if they do not provide fair notice of what is prohibited or required, or are so standardless that they permit seriously discriminatory enforcement.  FCC v. …

By Allyson B. Mullen – On August 28, 2013, FDA’s Center for Devices and Radiological Health issued a draft guidance, “The Applicability of Good Laboratory Practice in Premarket Device Submissions: Questions & Answers.”  This new, short guidance restates the requirements of the Good Laboratory Practices …

By Jennifer D. Newberger – An increasing number of devices employ radio frequency wireless technology.  This trend is likely to continue.  These devices present some new technological issues.  To respond to these new issues, FDA has just released a draft guidance titled, “Radio Frequency Wireless …

By Allyson B. Mullen – You may recall that French device maker PREVOR previously sued, and won, in litigation against FDA regarding FDA’s classification of Diphoterine® Skin Wash (“DSW”), a product used in industrial settings as a “first response” method to minimize chemical burns.  Hyman, …

By Kurt R. Karst –   Now that we've put the theme from The Jeffersons in your head . . . . On August 2, 2013, FDA will officially announce in a series of Federal Register notices the Fiscal Year 2014 (“FY 2014”) user fee rates under …

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 …