By Carmelina G. Allis – FDA has issued a draft guidance document to explain how FDA plans to implement the new eCopy program under Section 745A(b) of the Federal Food, Drug, and Cosmetic Act (“FDC Act”), which was added by the Food and Drug Administration …
By Jeffrey K. Shapiro & Jessica A. Ritsick – Under FDA’s regulations (10 C.F.R. § 10.75), the decision of an FDA employee (other than the Commissioner) is subject to supervisory review in four circumstances: (1) when an employee so requests; (2) when a supervisor initiates review; …
By Carmelina G. Allis – Should FDA’s Center for Devices and Radiological Health (“CDRH”) regulate medical mobile apps? Or should medical mobile apps be regulated by another office within FDA? Or should they be regulated by a separate entity under the Department of Health and …
By Jennifer D. Newberger – The Government Accountability Office (“GAO”) recently issued a report titled, “Medical Devices: FDA Should Expand Its Consideration of Information Security for Certain Types of Devices.” The report was intended to examine how FDA protects active implantable devices against information security risks that …
By Jeffrey K. Shapiro & Jessica A. Ritsick – ISO 13485 (2003) is an internationally recognized management system for the design and manufacture of medical devices. Most device manufacturers have quality systems intended to comply with ISO 13485. FDA has finally implemented a 2007 statutory …
By Jennifer M. Thomas & Anne K. Walsh – Yesterday, in a big win for industry, District Court Judge Rosemary Collyer granted French company PREVOR’s Motion for Summary Judgment in a case challenging FDA’s decision to regulate PREVOR’s Diphoterine® Skin Wash (“DSW”) product as a …
By Jennifer D. Newberger – On Thursday, September 20, the Food and Drug Law Institute (“FDLI”) and the Drug Information Association (“DIA”) co-sponsored a program titled “Unwrapping FDA’s UFA Package: What’s Inside the Statute – What’s Next?” The program discussed many aspects of the recently passed …
By Kurt R. Karst & JP Ellison – The U.S. Solicitor General filed a brief last week urging the U.S. Supreme Court not to grant a Petition for Writ of Certiorari filed earlier this year by a group of ear candle advocates after the U.S. …
By Jennifer D. Newberger – On September 6, FDA released a white paper titled “Strengthening Our National System for Medical Device Postmarket Surveillance.” This paper stems at least in part from the recommendation by the Institute of Medicine for FDA to “develop and implement a …
By Carmelina G. Allis – If you are a mobile app developer, be sure to review the FTC’s newly published guidelines on truth-in-advertising and privacy principles, “Marketing Your Mobile App, Get it Right from the Start.” They apply to you, whether you are a start-up …
By Alexander J. Varond – The Institute of Medicine (“IOM”) recently issued a paper titled “Accelerating the Development of New Drugs and Diagnostics: Maximizing the Impact of the Cures Acceleration Network: Workshop Summary.” The IOM paper summarizes the “Maximizing the Goals of the Cures Acceleration Network to …
By James R. Phelps – According to recent reports concerning the widely reported “whistleblower” scandal at FDA’s Center for Devices and Radiological Health (“CDRH”), in 2009, the CDRH dissidents involved in the affair, while still employed at FDA, filed a “secret” Federal False Claims Act suit …
By Kurt R. Karst – Just before Congress recessed for the month of August, and less than a month after the July 9th enactment of the FDA Safety and Innovation Act, several FDA-related bills were placed in the hoppers in the U.S. Senate and U.S. House …
By Jennifer D. Newberger – Perseverance can be an admirable quality, except when it is misguided. So it seems to be with Representative Edward Markey and Senator Jeff Merkley, who seem intent on convincing the public that devices cleared through the 510(k) process pose great risks …
By Jennifer D. Newberger – On August 10, 2012, FDA issued a draft guidance, “Refuse to Accept Policy for 510(k)s.” This draft guidance largely mirrors the recently issued draft guidance for premarket approval applications, “Acceptance and Filing Review for Premarket Approval Applications (PMAs),” on which we …
