Medical Devices

By Kurt R. Karst –       We’re now entering the second week of the shutdown of the federal government (or “the lapse period” as some have called it), and there does not appear to be an end in sight.  In fact, the environment in Washington, D.C. has …

By Jeffrey K. Shapiro – There has been a lot of talk about hostage taking during the recent federal government budget impasse.  But Congress is not the only one taking hostages in Washington.  The recent draft Medical Device Reporting (MDR) guidance reminds us (pp. 4-5) …

By Ricardo Carvajal & Kurt R. Karst – According to contingency plans drawn up by the Department of Health and Human Services, 45% of FDA’s nearly 15,000 staff were to be furloughed in the absence of enacted annual appropriations – popularly referred to as a …

By Jeffrey K. Shapiro – As everybody has noticed, FDA finalized its guidance on Mobile Medical Applications earlier this week.  We blogged on the draft version here. The final guidance is similar to the draft guidance – but with improved clarity.  Hence, it has expanded from …

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By Allyson B. Mullen – Earlier this summer, CDRH issued a new Draft Guidance for the Content of Premarket Submissions for Management of Cybersecurity in Medical Devices (the “Draft Guidance”).  We have previously posted on the Draft Guidance here.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