Regulatory & Compliance Perspectives

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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?

  8. A Brief Guide To ISO 13485's Design Controls In Medical Device Development 9/15/2023

    Design controls play a crucial role in the medical device development process by providing a systematic approach to manage risks, design requirements, and verification and validation activities. Let's explore the key elements of ISO 13485 that will help you manage the process effectively.

  9. Your Best Chance At Regulatory Compliance For Combination Products: Integrated Development 9/14/2023

    The FDA now defines a prefilled syringe, a product that was at one point considered “packaging” for a drug, as a constituent part of a combination product. The ultimate combination of the drug, its package, and its delivery device means that during development and manufacturing you need to combine both drug and device current good manufacturing practices (cGMPs) and quality approaches.

  10. The Landscape For Conducting Medtech Clinical Trials In The Dominican Republic 9/11/2023

    The Dominican Republic, a Caribbean nation with over 11 million people, is experiencing an upward trend in attracting medical device clinical trials. Let's look at how its healthcare system is constructed, as well as advantages and challenges of conducting medtech clinical research in the country.