By Jennifer D. Newberger – As part of the Medical Device User Fee Act of 2012 (MDUFA III) Commitment Letter, FDA and the medical device industry agreed to participate in a comprehensive assessment of the medical device review process. MDUFA III Commitment Letter (April 18, 2012), …
By Allyson B. Mullen & Jeffrey N. Gibbs – On November 25, 2013, CDRH issued the Final Guidance “Distribution of In Vitro Diagnostic Products Labeled for Research Use Only or Investigational Use Only: Frequently Asked Questions” (the “RUO Guidance”) (see our previous posts on the draft …
By Allyson B. Mullen – For many individuals, a diagnosis, be it life threatening or chronic, is scary. However, the trial and error process that can follow the diagnosis in order to find a therapy (e.g., drug, device and/or biologic) that works best for the patient …
An article published in the current edition of Regulatory Focus, the flagship publication of the Regulatory Affairs Professionals Society (RAPS), and authored by Hyman, Phelps & McNamara, P.C.’s Alexander J. Varond discusses the recent trends and developments in personalized medicine, including FDA’s current thinking and …
By Allyson B. Mullen – Now that the eCopy program is well underway, it might be a good idea to review how the program works and consider a few of the common pitfalls. Although nearly a year has passed since the final guidance document for the …
By Jay W. Cormier – Notwithstanding the government shutdown, on Tuesday, October 1st, FDA’s Center for Devices and Radiological Health (“CDRH”) issued a final guidance regarding filing for an investigational device exemption (“IDE”) for medical device early feasibility studies. At the heart of the guidance is that …
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. …
