In January 2024, the FDA released a draft guidance update on the Collection of Race and Ethnicity Data in Clinical Trials, originally issued in October 2016. For industry and the FDA, this guidance is important as it intends to standardize the approach for collecting and reporting race and ethnicity data in submissions–including information collected and reported from clinical studies for FDA-regulated products. The FDA is recommending the use of the Office of Management and Budget (OMB) race and ethnicity categories for investigational new drug applications (INDs), new drug applications (NDAs ..read more

The use of software in the healthcare field is here to stay. Technologies emerging over the past years are revolutionizing patient care today–from efficient electronic systems that store patient information to innovative medical device software (MDSW) options such as artificial intelligence that can drive patient management. In Europe, MedTech regulators aim to ensure innovation while safeguarding users from potential risks by developing robust frameworks and industry standards that include considerations on MDSW. NAMSA has drawn on our extensive expertise as a MedTech CRO and examined the cli ..read more

Sterilization is a critical step in manufacturing certain medical devices and Ethylene Oxide (EO or EtO) is the most commonly used method in the United States. However, the FDA and EPA are committed to reducing reliance on EO while ensuring a stable supply of sterile medical devices. This multipronged approach includes regulatory flexibilities, supply chain analysis, collaboration, innovation, and communication with the public, medical device manufacturers and other interested parties.   EPA Final Rule Announcement The U.S. Environmental Protection Agency (EPA) recently announced (March 1 ..read more

On 12 February 2024, the Medical Device Coordination Group (MDCG) issued a new guidance document, MDCG 2024-2. The European Medical Device Nomenclature (EMDN) is required to be updated yearly based on the practical use of the EMDN and feedback from its users. This MDCG document describes the processes that will be used to make these annual updates. As well as the annual updates, the MDCG document also explains the process for any ad-hoc updates to the EMDN. There are three defined groups involved in this process: MDCG Nomenclature Working Group – This expert group provides assistance and advi ..read more

On February 02, 2024, the U.S. Food and Drug Administration (FDA) published the Quality Management System Regulation (QMSR), which amends 21 CFR Part 820 – Quality System Regulation (QSR). This ruling includes a significant change since the FDA has incorporated by reference the Quality Management System (QMS) requirements of ISO 13485:2016. The QMSR is just a few pages in length, demonstrating that the FDA is focused on simplifying and streamlining the regulation to reduce the burden on device manufacturers, while also ensuring the safe and effective manufacture of products. The FDA recognizes ..read more

When it comes to medical device development, regulatory compliance is essential. In the United States, the Food and Drug Administration (FDA) is responsible for regulating medical devices and, specifically, their Accreditation Scheme for Conformity Assessment (ASCA Program) provides accreditation to laboratories that assess medical devices for compliance with regulatory requirements. Initiated as part of the enactment of the Medical Device User Fee Amendments of 2017 (MDUFA IV), the ASCA Pilot Program clears the first hurdle in the medical device premarket regulatory process for manufacturers ..read more

In January 2024, a series of new MDCG Guidance documents relating to medical device and in vitro diagnostic medical device vigilance were published on the European Commission website. These five documents – the first MDCG guidance published this year, consist of a Device Specific Vigilance Guidance (DSVG) Template (MDCG 2024-1) and four further DSVGs for ‘Specific Devices’ including devices for cardiac ablation, coronary stents, cardiac implantable electronic devices and breast implants. Since this is not an exhaustive list, it is assumed that further DSVGs for said ‘Specific Devices’ will be ..read more

On 11 July 2023, and once more on 5 January 2024, the European Commission updated its list of harmonized classification and labeling of chemicals. Regulation (EC) No 1272/2008 on classification, labeling and packaging of substances and mixtures (a.k.a CLP Regulation), particularly Annex VI (list of harmonized classification and labeling of hazardous substances), has been amended by the two following Regulations: Commission Delegated Regulation (EU) 2023/1435 of 2 May 2023 (20th Adaptation to Technical Progress [ATP]): 4 entries were revised. The new classifications will apply as of 1 February ..read more

On 23 January, the European Commission published another proposal to amend (EU) 2017/746 on In Vitro Diagnostic Regulation (IVDR). They proposed: A further extension of the transitional provisions for certain In Vitro Diagnostics (IVDs). The intent is to reduce the risk of shortages of certain products, such as high-risk IVDs. These are used, for example, to test for infections in blood or organ donations and for blood grouping in transfusions. A phased implementation of the finalized electronic systems within the European Database on Medical Devices (‘EUDAMED), rather than waiting until al ..read more

The evaluation of a wound dressing is dependent on the performance of the materials they are made from, their microarchitecture and how they are constructed. To ensure dressings are effective in clinical wound management it is essential that they are resistant to the mechanical and biochemical wound environment, effectively absorb exudate, remain in place for the required treatment period but are able to be easily removed and acceptable to both patients and health care professionals. In recent years, an acceleration of chronic wound complications has led to the rapid development of a wide rang ..read more