FDA ESTABLISHES A NEW DIGITAL HEALTH ADVISORY COMMITTEE
The world of technology is moving at lighting speed. We are experiencing advances in software capabilities, interactions with automated services, and a far greater emphasis on how we are becoming more reliant on digital processes in our everyday lives. Case in point, when was the last time you were able to actually talk to a […]
FDA UPDATE: FINAL GUIDANCE SUBMISSION AND REVIEW OF STERILITY INFORMATION IN PREMARKET NOTIFICATION (510(K)) SUBMISSIONS FOR DEVICES LABELED AS STERILE
On Jan. 8, 2024, the FDA updated the final guidance on “Submission and Review of Sterility Information in 510(k) Submissions for Devices Labeled as Sterile”. Within the document, the FDA announces that it has recategorized vaporized hydrogen peroxide (VHP) to be an Established Category A sterilization process. As such, this places VHP in the same […]
MDCG UPDATES Q&A ON IMPORTERS AND DISTRIBUTORS
The Medical Device Coordination Group (MDCG), the regulatory body that works toward ensuring the safe and effective use of medical devices in Europe, recently updated a Q&A document on how both the Medical Device Regulation (MDR) and In Vitro Diagnostics Regulation (IVDR) apply to importers and distributors. Under both regulations, an economic operator is defined […]
FDA’S LABORATORY DEVELOPED TESTS ENFORCEMENT RULE
Laboratory developed tests (LDTs) are in vitro diagnostic devices (IVDs) for use in clinical settings and play a vital role in the health industry. LDTs are still regulated by the federal government, via the Department of Health and Human Services (HHS) and the Food and Drug Administration (FDA) under the Public Health Service Act. Laboratories […]
CANADA’S DEVELOPING ROLE IN THE MEDICAL DEVICE REGULATORY ARENA
Canada may not be one of the larger medical device markets on the global scene, but its regulatory structure is quite substantial. Its medical industry, consisting of mainly small to medium-sized organizations, is rooted in a solid regulatory foundation that has matured over time. While their first medical device structure was implemented under Canada’s Food and Drugs […]
EXCEL SPREADSHEET REQUIREMENTS AND VALIDATION PROCESS
Under 21 CFR 11.10 Controls for closed systems, all spreadsheets that are used to facilitate the product and/or quality system decision-making processes need to be within compliance, including requirements for validation, accurate copies and protection of records, limited system access to authorized individuals, audit trails, authority, operational and device checks, training, electronic signatures, and change […]
DO NOTIFIED BODIES HAVE THE CAPACITY TO MANAGE THE MDR AND IVDR TRANSITIONS?
While recent information shows that both Medical Device Regulation (MDR) and In Vitro Diagnostics Regulation (IVDR) applications have been on the rise, there are concerns as to whether the Notified Bodies have the capacity and competency to accommodate this trend. In March of this year, the EU commission released Regulation (EU) 2023/607, with immediate effect. […]
MANAGING CHANGES AND MAINTAINING COMPLIANCE
Under the Medical Devices Regulation (MDR) and In Vitro Diagnostic Medical Devices Regulation (IVDR), devices need to meet the applicable “harmonized standards” to demonstrate conformity with the essential requirements. If a harmonized standard referenced in the technical documentation (including the DHF) is updated, manufacturers are expected to assess the impact and incorporate any necessary changes […]
UPDATES TO Q-SUB GUIDANCE PRIOR TO RELEASE OF NEW PRE-SUB DRAFT GUIDELINES
The Q-Submission Program, also known as the Pre-Submission Program, is an initiative by the U.S. Food and Drug Administration (FDA) aimed at facilitating the development and review of medical devices. It provides an opportunity for medical device manufacturers to interact with the FDA before submitting their formal applications, allowing for early feedback and guidance. The […]
FDA ISSUES GUIDANCE CONTENT OF PREMARKET SUBMISSIONS FOR DEVICE SOFTWARE FUNCTIONS
The FDA released new guidance for the Content of Premarket Submissions for Device Software Functions [1] in June 2023. This guidance replaces the preexisting guidance from May of 2005. Since then, technological advances have caused software to become an important part of medical devices. The final guidance moved to a simplified risk-based approach to determine […]
