One of the challenges in risk analysis of medical devices is the diversity of use scenarios based on the target medical purpose and use environments. That is why ISO 14971:2019, the recently revised International Standard for Risk Management of Medical Devices, requires that risk analysis begin with a clear understanding of the intended use and reasonably foreseeable misuse.
Read MoreRisk analysis is a key requirement of ISO 14971:2019, the recently revised International Standard for Risk Management of Medical Devices. As outlined in Clause 5.1, the manufacturer shall perform risk analysis for the particular medical device as described in clauses 5.2 to 5.5. Here is how a Preliminary Hazard Analysis (PHA) can help.
Read MoreMarket for interconnected medical devices is projected to grow but the regulatory pathway is still evolving. A new FDA guidance offers helpful recommendations for design and premarket submission.
Read MoreTimely MDR reporting is a challenging regulatory requirement for the industry. A new FDA guidance provides much-needed relief during a pandemic.
Read MoreCybersecurity of medical devices is a rapidly evolving area of concern. Here is an update on recent FDA activities.
Read MoreThe third edition of ISO 14971, just published, aims to clarify requirements and improve effectiveness of medical device risk management.
Read MoreThe current revision of ISO 13485:2016 has new requirements for risk management. Here are some questions to consider and guidance for implementation.
Read MoreUpdated draft guidance provides recommendations for design, labeling, and premarket documentation. Industry response points to a long road ahead before it can be finalized.
Read MoreFDA is expanding the Abbreviated 510(k) Program with a Safety and Performance-based Pathway for certain medical devices.
Read MoreA frequent reason for FDA warning letters is an inadequate corrective action plan to form-483 observations. When it is related to risk management, you need to dig deeper.
Read MoreFDA has issued a draft guidance on the Safer Technologies Program (STeP) for Medical Devices to promote expedited development and regulatory review of safety innovations. This is certainly a STeP in the right direction!
Read MoreISO 13485 was revised in 2016 with several new requirements and a stronger emphasis on risk and planning. In fact, the older 2003 version did not define the term “risk” under Terms and Definition (Clause 3). A considerable amount of detail is now provided to clarify the concept of risk, which pertains to safety or performance requirements of the medical device or meeting applicable regulatory requirements within the scope of the revised standard.
Read MoreFDA first announced its intention to “harmonize and modernize” the Quality System Regulation (QSR) for medical devices in Spring of 2018. The idea is to modernize the regulatory framework and harmonize the requirements with the newly revised ISO 13485:2016, the international standard for medical device quality management systems.
Well, it’s about time!
Read MoreA warning letter is the agency’s way of giving you a final chance. Behave, or you will face painful enforcement actions such as a recall, seizure, civil money penalties, or worse still, jail time for responsible individuals. It carries a big stick, and predictably, manufacturers have been quite fearful of receiving a warning letter.
Read MoreArtificial intelligence (AI) based devices are unique in their ability to learn from real-world use and experience, which can translate to rapid improvement in performance and new applications. In a sign of recognition of this capability, the FDA is proposing a new regulatory framework for review and approval of modifications to these devices after they have been cleared or approved.
Read MoreCongress first added the Least Burdensome provisions to the Food, Drug and Cosmetics Act (FD&C) through Food and Drug Administration Modernization Act (FDAMA) of 1997. Additional provisions were added through the FDA Safety and Information Act (FDASIA) in 2012 and the 21st Century Cures Act (Cures Act) in 2016.
Read MoreRecently, the FDA has taken 2 major steps to encourage innovation in medical devices. The first is finalizing guidance on the Breakthrough Device Program, which will enable accelerated approval of innovative medical devices that more effectively diagnose or treat life-threatening or irreversibly debilitating conditions.
Read MoreLast month, the FDA issued a Medical Device Enforcement and Quality Report, which provides a summary of FDA annual inspections data and a good explanation of their current approach to regulatory compliance. In providing this data and their commentary, the FDA is telling MedTech companies that they have a big stick (i.e. is the number of annual inspections has gone up in the last 10 years), but they are also offering a sweet carrot (i.e. they are taking a “risk-based” enforcement approach) to focus more on quality rather than simple compliance.
Read MoreAchieving and sustaining Regulatory Compliance is a huge resource drain for Medical Device companies. That is why it is refreshing to hear that the FDA is now renewing its focus on a least burdensome approach to all regulatory activities.
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