Last week, FDA finalized the guidance document, “Postmarket Management of Cybersecurity in Medical Devices.” We previously blogged on the draft guidance released in early 2016 (here). The final guidance is similar to the draft issued in early 2016. There are, however, several noteworthy and significant edits. In …
Our firm has previously posted some summaries of the 21st Century Cures Act (Cures Act), which the President signed into law on December 13, 2016 (Public Law No. 114-255). (Those summaries are available here, here, and here.) This post focuses on only one section of the …
In June 2016 CDRH released the draft guidance “Factors to Consider Regarding Benefit-Risk in Medical Device Product Availability, Compliance, Enforcement Decisions” (see our earlier post here). In the waning days of 2016, CDRH finalized the guidance. The final guidance is largely unchanged from the draft with …
Approximately one year ago, on New Years Eve, FDA surprised the device industry with a draft guidance on emerging postmarket device signals (see our post on the draft guidance here). On December 14, FDA issued the final guidance document: Public Notification of Emerging Postmarket Device …
The 21st Century Cures Act was signed into law on December 13, 2016. The Act addresses acceleration of medical product discovery, development, and delivery. Hyman, Phelps & McNamara, P.C. ("HP&M") will hold complimentary webinars on Thursday, January 12, 2017 from 12:00-1:30 PM (Eastern) and Wednesday, …
We’ve previously posted some summaries of the 21st Century Cures Act (Cures Act), which the President signed into law on December 13, 2016 (Public Law No. 114-255). (Those summaries are available here, here, and here.) This post focuses on only one section of the new …
Amid the partisan gridlock of the past few years, one of the few things Democrats and Republicans have agreed on is the need to reform FDA! Accordingly, Congress has just passed, and the President has indicated he will sign, the 21st Century Cures Act (Cures …
There has been a spate of recent news articles about the potential use of the Congressional Review Act (CRA) to overturn final rules issued toward the end of the Obama Administration. That prompted us to see which of FDA’s recently issued final rules might be …
By Serra J. Schlanger – The Department of Health & Human Services Office of Inspector General (“HHS OIG”) recently released its work plan for fiscal year 2017. The annual work plan summarizes what HHS OIG plans to review during the upcoming year as part of its …
By Allyson B. Mullen & Jeffrey N. Gibbs – All this year, FDA had signaled it intended to finalize the guidance for Laboratory Developed Tests (LDTs). On Friday November 18, 2016, FDA abandoned the effort, stating that it will not provide the requisite 60-day notice to Congress …
By Jennifer D. Newberger – Though we are certain it was not only our blog post on the draft Medical Device Reporting ("MDR") guidance that persuaded FDA not to adopt some of the positions it proposed in its Draft Guidance, Medical Device Reporting for Manufacturers (July 2013), …
By Jennifer M. Thomas – Last week, FDA rolled out a new online reporting program, titled “Reporting Allegations of Regulatory Misconduct,” with little fanfare. No blog post in FDA Voice, no press conference, and even the (longwinded) name of the program seems calculated to send the …
For almost 40 years FDA has allowed device firms to promote their device while a 510(k) submission is still pending. Yet, questions about how to apply this policy still remain. In an article newly published in MedTech Insight, titled "Promoting Your 510(k)-Pending Device: 5 Questions …
By Jeffrey K. Shapiro – In 1976, FDA first began comprehensive regulation of medical devices. Among the new statutory provisions, there was one requiring persons registering with FDA to list all marketed devices. Each device on the list was to be accompanied by a copy of …
By Anne K. Walsh & Andrew J. Hull – A problematic decision from the Ninth Circuit appears to impermissibly grant FDA authority to regulate the practice of medicine, and to further muddy the regulatory morass governing off-label use of products. We hope other courts recognize this …
