• RF Quarterly

    Current good manufacturing practices and quality system design

    Quality by design, or the principle of building quality into a product and testing, was introduced in 2011 as process validation guidance. Today it is codified within the Title 21 section 820. The quality management system (QMS) encompasses this principle in all areas of healthcare manufacturing – including drugs, biologics, and devices – and, with compliance, can ensure the safety and effectiveness of all manufactured products. The establishment, implementation, and maint...
  • RF Quarterly

    Medical device quality management systems

    Introduction A quality management system (QMS) is one of the five medical device conformity assessment elements. 1 Manufacturers of medical devices are expected to implement, document, and maintain a QMS that “ensures the medical devices it designs, manufactures, and supplies to the market are safe, perform as intended, and comply with the relevant provisions of the regulations in the countries where the product is made available.” 2   Today, a QMS is seen as a ...
  • Feature ArticlesFeature Articles

    The changing regulatory landscape for laboratory developed tests

    The COVID-19 pandemic has highlighted the importance of reliable and accurate diagnostic tests. Laboratory developed tests (LDTs) do not typically require premarket review. The US Food and Drug Administration (FDA) has repeatedly proposed more rigorous regulatory frameworks for LDTs but has been unsuccessful owing to concerns about the impact on test availability and innovation. In this article, the authors describe the existing regulations and consider both sides of the d...
  • Regulatory NewsRegulatory News

    Warning letter: FDA blasts Innova for falsifying data, GMP violations

    Editor's note: This article has been updated to include a statement from Innova. The US Food and Drug Administration issued a warning letter on 10 June to Innova Medical Group for distributing unauthorized SARS-CoV-2 rapid antigen tests and "false or misleading" information in the tests’ labeling.   The warning letter comes after FDA inspected two of the firm’s facilities in Pasadena and Brea, CA over the course of several weeks in March and April.   FDA also ...
  • Feature ArticlesFeature Articles

    COVID-19 diagnostics: Moving from laboratory to home-based testing

    The US Food and Drug Administration (FDA) has worked closely with diagnostics developers during the past year to facilitate access to COVID-19 testing and accelerate development of home-based tests. By creating a flexible regulatory framework, the agency has enabled authorization of nearly one COVID-19 diagnostic per day, including at-home tests that have a critical role in the ongoing response to SARS-CoV-2. Introduction The emergence of the COVID-19 pandemic create...
  • Feature ArticlesFeature Articles

    COVID-19 IVD test kits: Expedited response by Asian regulatory authorities

    After COVID-19 quickly spread from China to nearby Asian countries in early 2020, regulatory authorities in those neighboring countries adapted rapidly to introduce regulatory pathways for approval of in vitro diagnostic (IVD) test kits to facilitate widespread testing and halt spread of the disease. An additional challenge was that authorities had to work around strict quarantine restrictions, and applications and consultations had to be conducted online instead of in per...
  • Regulatory NewsRegulatory News

    TGA explains how it will handle lapsed conformity assessments due to MDR delays, COVID

    Australia’s Therapeutic Goods Administration (TGA) on Tuesday released guidance explaining its approach to medical device conformity assessment recertification in light of delays in the implementation of the EU Medical Devices Regulation (MDR) and disruptions caused by the COVID-19 pandemic.   “[TGA] is issuing this guidance to inform sponsors … about the general approach the TGA will take to the lapsing of conformity assessment documents due to delays in audits due ...
  • Feature ArticlesFeature Articles

    MDR, IVDR, and compliance: A guide for distributors

    Distributors must prepare for new incoming requirements under EU medical device and in vitro diagnostic device regulations. The importance of establishing an effective quality management system, drafting comprehensive contractual agreements and, if required, engaging notified bodies, has created much uncertainty for distributors. To fulfil these new requirements and maintain device supply chains, it is essential for distributors to act early, ensure sufficient in-house com...
  • Regulatory NewsRegulatory News

    Novartis’ Zolgensma Joins Growing List of Medicines to Lose Accelerated Assessment Status in EU

    The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) recently announced its decision to remove Novartis’ spinal muscular atrophy gene therapy onasemnogene abeparvovec from its accelerated assessment program. CHMP did not announce its reasoning behind the decision, which effectively means that the treatment, approved in the US as Zolgensma and launched at a price of more than $2 million, will be reviewed in the EU in 210 days rather...
  • Regulatory NewsRegulatory News

    Experts Tell Device Companies Not to Fret Over QMS Transition

    Ahead of the proposed shift away from the current US Food and Drug Administration (FDA) quality management system (QMS) CFR 21 Part 820 regulation toward ISO 13485:2016, a new white paper sheds light on how the action will impact medical device development. The white paper identified three interrelated principles that will define the direction of the agency’s process, which has yet to be clearly defined, after the transition . These principles relate to the concept of ...
  • Regulatory NewsRegulatory News

    WHO Consults on QMS Guideline for Regulators

    The World Health Organization (WHO) in January released for consultation a draft of its upcoming guideline on implementing quality management systems (QMS) for national regulatory authorities (NRAs).   Specifically, the 96-page draft guideline is meant to fill the gaps for NRAs looking to implement a QMS based on the International Organization for Standardization’s (ISO) 9001:2015 Quality Management Systems – Requirements standard, as other existing QMS guidelines do n...
  • Regulatory NewsRegulatory News

    Sentinel: FDA Outlines Five-Year Roadmap

    As the US Food and Drug Administration's (FDA) Sentinel Initiative approaches its 11 th anniversary, the agency on Wednesday laid out its vision for enhancing the system over the next five years.   First launched as a pilot program in 2008, the Sentinel Initiative encompasses FDA’s effort to meet obligations set by Congress in the 2007 Food and Drug Administration Amendments Act to develop a system for active postmarket risk identification and analysis for medical p...