Regulatory & Compliance Perspectives

  1. How Does The New European Batteries Regulation Affect Medical Devices? 10/19/2023

    On July 12, 2023, the hotly anticipated new Regulation (EU) 2023/1542 on batteries and waste batteries (“Batteries Regulation”) was adopted. The new regulation replaces the previous Directive 2006/66/EC on batteries and aims at regulating the entire battery life cycle and value chain in an integrated manner. The impact will be felt not only by the usual battery-driven industries but also by manufacturers of battery-powered medical devices and in vitro diagnostic devices.

  2. SaMD PCCP Implementation Beyond AI/ML: Considerations & Challenges 10/13/2023

    This is the third and final installment in a three-part article series on postmarket change controls and implementing a Predetermined Change Control Plan (PCCP) for Class II software as a medical device (SaMD) products beyond artificial intelligence/machine learning (AI/ML).

  3. FDA's Proposed Laboratory-Developed Tests Rule Raises Many Questions But Provides Few Answers 10/11/2023

    The FDA has issued a new proposed rule on laboratory-developed tests (LDTs), expressly defining LDTs as a type of in vitro diagnostic (IVD) device, and subject to device regulations, including registration and listing, premarket review, and more. The FDA is accepting comments on the proposed rule through December 4.

  4. ML-Powered Medical Devices: 10 Tips For Regulatory Compliance 10/11/2023

    This article summarizes the 10 principles in the FDA’s Good Machine Learning Practice for Medical Device Development: Guiding Principles, each of which is critical in developing medical devices powered by machine learning (ML). The author also provides tips for how you can employ them.

  5. Deciphering New U.S. Laws Around Predetermined Change Control Plans 10/10/2023

    As is typical with legislative language, the language used in Section 3308 of the Food and Drug Omnibus Reform Act (FDORA) can be difficult to understand, with multiple cross-references to existing laws and use of legal terminology that can be cryptic. Here's our interpretation of key passages relevant to postmarket change controls and implementing a Predetermined Change Control Plan (PCCP) for Class II Software as a Medical Device (SaMD) products.

  6. Medical Device Postmarket Change Controls & FDA 510(k) Software Modification Guidance 10/4/2023

    Many medical device manufacturers will continue to make changes after the initial commercialization of the device, and such postmarket changes can be planned or unplanned. As the first article in a three-part series about predetermined change control plans, this article discusses the six steps involved with postmarket change controls and current FDA guidance regarding 510(k) device software modifications.

  7. India Aims To Boost Medical Device Industry With New Initiative 9/29/2023

    India's government has approved a new initiative aiming for a 20% annual growth rate for medical devices, which is dubbed as a "Sunrise Sector." The initiative will streamline regulations, add a new push for manufacturing capacity, and strengthen opportunities for R&D collaboration. The aim is for both local and global companies to benefit.

  8. EU Medtech Labeling Compliance & The Competitive Advantage Of A Digitalized Process 9/26/2023

    In the medtech industry where time and regulatory compliance are crucial, optimizing and digitalizing your labeling processes are essential for bringing medical devices to market quickly and play a vital role in keeping products available to patients and healthcare providers in the EU.

  9. Risk Tool Selection With ICH Q9(R1) In Mind 9/19/2023

    This article focuses on the formality concept discussed in the revision of ICH Q9 Quality Risk Management released earlier in 2023. The authors provide a helpful overview of what risk tools are appropriate to use during certain types of scenarios, and what the team composition should look like.

  10. FDA's Grace Period For Medical Device Cybersecurity Is Over. Are You Ready? 9/18/2023

    The FDA had established a grace period for all medical device manufacturers to ensure that you are incorporating cybersecurity during the design and validation of cyber devices. The end date of the grace period, and the seminal date in medical device cybersecurity enforcement, is Oct. 1, 2023. Are you prepared?