Draft Guidance on Use-Related Risk Analysis for Combination Products

In a significant move aimed at enhancing the safety and effectiveness of combination products, the U.S. Food and Drug Administration (FDA) has recently released a draft guidance document focusing on the use-related risk analysis (URRA) for these complex products. This draft guidance represents a crucial step in refining regulatory practices and ensuring that combination products—those […]

FDA Issues Remanufacturing Guidance

On May 10, 2024, the FDA issued a guidance document on “Remanufacturing of Medical Devices.” Remanufacturing is the processing, conditioning, renovating, repackaging, restoring, or any other act done to a finished device that significantly changes the finished device’s performance or safety specifications, or intended use. The document is intended help clarify whether activities performed on […]

FDA Whitepaper: Artificial Intelligence & Medical Products – What You Need to Know

Artificial intelligence (AI) holds immense  potential to revolutionize healthcare, offering  advancements in medical product development, improving patient care, and augmenting the capabilities of health care practitioners. With a shared commitment toward fostering innovation and upholding quality, safety, and effectiveness, FDA plans to align their efforts to advance the responsible use of AI for medical products. […]

Guidelines Updated on Phthalates

Phthalates are a group of chemicals commonly used as plasticizers to make plastics more flexible, durable, and transparent. Recently, the EU Commission requested the first update from SCHEER since 2019, to which SCHEER has responded by providing information as to how the manufacturing community has evaluated potential alternatives to the use of phthalates and how this will impact both the design and use of their products.

IMDRF: Updates on Current Working Groups

The International Medical Device Regulators Forum (IMDRF) held its 25th annual meeting in Washington, DC on March 12, 2024. Of the topics discussed was the progress of the various working groups and the mention of new guidance documents harmonizing global marketing review requirements, which is highly sought after by industry. Working groups that were highlighted […]

Remote Regulatory Assessments: What You Need To Know

Travel restrictions, brought on during the COVID-19 pandemic, forced the US Food and Drug Administration (FDA) to adapt its mode of operations with respect to field inspections by employing a remote regulatory assessments (RRA) strategy. FDA used these RRAs to ensure continuity of inspections for compliance with applicable FDA requirements where an on-site presence was not […]

FDA Third Party Review Programs

In August 1996, the FDA launched what was known as the Voluntary Third Party 510(k) Review Pilot Program. The program’s aim was to test out the usage of third parties for performing primary reviews of some medical devices under the 510(k) process in order to improve speed and efficiency. The limitation of the device eligibility was […]

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 […]