• where experts go to learn about FDA
  • Véronique Li, Senior Medical Device Regulation Expert

    • Update on CDER, CBER, and CDRH Meetings with IndustryJune 9th, 2023

      On May 11, 2023, the U.S. Department of Health and Human Services declared the long-awaited end of the federal COVID-19 Public Health Emergency.  The pandemic had changed the way people live, work and communicate.  Such changes are not limited to personal circumstances.  The pandemic also …

    • FDA to Require Breast Density Notification Amongst Other Updates to Mammography RegulationsMarch 16th, 2023

      Earlier this month, FDA published a final rule to update the mammography regulations, issued under the Mammography Quality Standards Act of 1992 (MQSA) and the Federal Food, Drug, and Cosmetic Act (FD&C Act). The MQSA was passed to ensure, among other things, that nationwide, patients …

    • eMDR System EnhancementsMarch 9th, 2023

      On March 17, 2023, enhancements to FDA’s electronic Medical Device Reporting (eMDR) system will go live. Manufacturers who submit reports via the FDA Electronic Submissions Gateway are being advised to update their systems by this time. Those who use eSubmitter will notice changes in the …

    • QMSR Harmonization Curiously Missing from Spring 2023 Regulatory AgendaMarch 7th, 2023

      A year ago, we blogged about a proposed rule that would replace the Quality System Regulation (QSR) at 21 C.F.R. Part 820 with a newly named Quality Management System Regulation (QMSR) (see here). The proposed rule was published on February 23, 2022 and was first …

    • FDA Publishes Final Rule to Amend and Reduce Regulatory Burden on Outdated and Duplicative Requirements as They Pertain to Radiological Health RegulationsFebruary 16th, 2023

      Sections of the radiological health regulations have been updated with the goal of lessening regulatory burdens. The regulations contain many requirements that are over 30 years old. These regulations apply to radiation emitting products, including not just medical devices but all other radiation emitting products …

    • FDA and Health Canada eSTAR Pilot is Open and Accepting Participant RequestsJanuary 17th, 2023

      A joint eSTAR pilot (which we previewed in November) between FDA and Health Canada has now been launched. This pilot program will test the use of a single eSTAR application submitted to both regulatory bodies. For those unfamiliar or needing a refresher, eSTAR is an interactive …

    • FDA’s Recent Update to the Digital Health Policy NavigatorDecember 21st, 2022

      In our previous blog post, we provided a flowchart for the Digital Health Policy Navigator’s process so that our blog readers can quickly review the seven steps in determining whether their product’s software functions may be potentially the focus of FDA oversight. Two days after …

    • Is my Software a Medical Device? Use the Digital Health Policy NavigatorDecember 12th, 2022

      With the explosion of health‑related software, many software developers are generating products with functionality that is subject to regulation by the Food and Drug Administration (FDA).  If you are a manufacturer of implants that go into the human body for the treatment of disease, it’s …

    • Discounts Available! Submit a Small Business Certification Request Today for a Reduced Medical Device User FeeNovember 15th, 2022

      In our last blog post, we advised medical device companies to consider applying to FDA’s Small Business Program to help with the noticeably higher user fees for FY2023. In this blog post, we provide a primer on user fees and the Small Business Program. User Fees User …

    • MedTech Conference DownloadNovember 9th, 2022

      At the latest MedTech conference held in Boston, MA from October 24-26, we heard from FDA officials and industry representatives on a range of topics. Below, we provide a snapshot of the three-day event: Update on the International Medical Device Regulators Forum (IMDRF) The IMDRF conference was …

    • Like Everything Else, Medical Device User Fees Are Not Immune to Price IncreasesOctober 21st, 2022

      If you have purchased anything in recent months or kept up with economic reports, you are familiar with the unwelcome observation: “Prices have gone up!” That could not be more true than in the area of medical device user fees. Medical Device User Fees After the Congressional …

    • Transition Plans for Covid-19 Products are Amongst CDRH FY2023 PrioritiesOctober 19th, 2022

      Last week, our blog post advised planning a transition strategy in advance of the news of the termination of the Covid-19 public health emergency. On October 17, 2022, FDA published the list of CDRH proposed guidances for FY 2023 (see here). Amongst CDRH’s highest prioritized …

    • Planning for the End of the COVID-19 Public Health EmergencyOctober 14th, 2022

      “We still have a problem with COVID. We’re still doing a lot of work on it. But the pandemic is over. If you notice, no one is wearing masks. Everybody seems to be in pretty good shape. And so I think it’s changing.” President Biden made …

    • Electronic Submission Template for Medical Device 510(k) SubmissionsOctober 6th, 2022

      Nearly one year after FDA published a draft guidance on its Electronic Submission Template for Medical Device Submissions (see our blog post here), the Agency is back to formally introduce the widespread implementation of the electronic Submission Template And Resource (eSTAR) electronic submission template for …

    • Allegations of Regulatory Misconduct Against Medical Device Manufacturers: Greater Transparency NeededOctober 4th, 2022

      Allegations of regulatory misconduct are claims that a medical device manufacturer or marketers of medical devices operate in such a way that violates the law. Allegations may include failure to register and list a medical device, promotion of a device outside the scope of its …