Regulatory & Compliance Perspectives

  1. A Look Ahead: US FDA And Medical Device Regulations In 2021 3/10/2021

    Now that we are in 2021, what big developments can we expect from FDA in general and with regard to medical devices in particular? This article explores some of the FDA initiatives and activities worth following this year. 

  2. The 6-Step Checklist For IVDR Compliance 3/8/2021

    The in vitro diagnostic devices industry has until May 25, 2022, to bring products, documentation, and quality management systems into compliance with the new EU Regulation on In Vitro Diagnostic Devices 746/2017. Are you ready?

  3. Germany’s Digital Medical Device Regulations: A Framework For The World To Follow, Part III 2/26/2021

    Germany's BfArM, or the Federal Institute for Drugs and Medical Devices, released a new guide in August 2020 detailing the requirements for digital health application manufacturers in order to make your DiGAs available to the more than 73 million participants in the German statutory health insurance. In this concluding article in the series, John Giantsidis of CyberActa, Inc. delves into the interoperability, robustness, consumer protection, and patient safety requirements. Other countries will likely soon follow Germany's example.

  4. FDA’s COVID-19 PREPP Initiative Summary Report — Key Takeaways For Manufacturers 2/19/2021

    Published in January 2021, the FDA COVID-19 Pandemic Recovery and Preparedness Plan (PREPP) Initiative Summary Report is the culmination of work performed by the FDA’s PREPP Initiative, which launched in April 2020 to examine lessons learned from the agency’s response to the global COVID-19 pandemic. This article provides a brief overview of the report’s overarching themes and highlights key regulatory insights for manufacturers in light of two action areas in particular.

  5. Germany’s Digital Medical Device Regulations: A Framework For The World To Follow, Part II 2/12/2021

    Germany's BfArM, or the Federal Institute for Drugs and Medical Devices, released a new guide in August 2020 detailing the requirements for digital health application manufacturers in order to make your DiGAs available to the more than 73 million participants in the German statutory health insurance, and other countries will likely follow in its footsteps. In Part II of this three-part series, John Giantsidis of CyberActa, Inc. examines the data security requirements.

  6. ISO 14971:2019 — Clarifying Benefit, Risk, & Benefit-Risk 2/8/2021

    This is the third in a series of articles on the changes in the medical device risk management standard ISO 14971 that were released in Dec. 2019 and supported by guidance in the ISO TR 24971:2020 technical report or guidance. This article by Edwin L. Bills, member of ISO TC 210 JWG1, covers the change in the process for benefit-risk covered in Clause 8 of the standard.

  7. An ISO 14155:2020 Primer — Good Clinical Practice For Medical Device Trials 2/2/2021

    An analysis of the recently released ISO 14155:2020, "Clinical investigation of medical devices for human subjects — Good clinical practice," a standard developed to guide clinical research professionals during the design, conduct, recording, and reporting of clinical trials related to the safety and effectiveness of medical devices.

  8. Germany’s Digital Medical Device Regulations: A Framework For The World To Follow, Part I 1/29/2021

    Germany's BfArM (the Federal Institute for Drugs and Medical Devices) released a new guide in August 2020 detailing the requirements for digital health applications, and other countries will likely follow in its footsteps. John Giantsidis, president of CyberActa, Inc., gives an overview of the situation and will cover the many privacy requirements noted in the new guide in Part 1 of this three-part article series.

  9. Avoiding ISO 14971 Mistakes — What Does “Harm” Really Mean? 1/27/2021

    In the first two parts of this three-part series on ISO 14971 terminology, we discussed the terms “hazard” and “hazardous situation” in detail. In this third and final part, we will review the term “harm,” provide examples to illustrate how you can define potential harms applicable to your medical device, and explain how you can link them to relevant hazards and hazardous situations. 

  10. With Release Of New Guidance Document, FDA Launches Safer Technologies Program for Medical Devices 1/25/2021

    The FDA’s Center for Devices and Radiological Health (CDRH) released the Safer Technologies Program for Medical Devices (STeP) Guidance for Industry and Food and Drug Administration Staff on January 6, 2021, with plans to begin accepting applications for STeP beginning March 8, 2021. Is this a good fit for your medical device or device-led combination product?