Regulatory & Compliance Perspectives
-
ICH Guideline Q9(R1) On QRM, Part 2: Subjectivity & Supply Continuity
3/7/2023
The long-awaited revision to ICH’s harmonized tripartite guidance on Quality Risk Management, Q9(R1), was adopted on January 18. This article focuses on the guidance's new topics of subjectivity and the role of QRM in addressing product availability risks.
-
The FDA Regulatory Landscape For AI In Medical Devices
3/3/2023
This article reviews the existing FDA programs impacting artificial intelligence (AI) / machine learning (ML) technologies in medtech, as well as the agency's priority list for releasing related guidances in 2023.
-
ICH Guideline Q9(R1) On QRM, Part 1: Formality & Risk-Based Decisions
2/28/2023
The long-awaited revision to ICH’s harmonized tripartite guidance on Quality Risk Management (QRM), Q9(R1), was adopted on Jan. 18, 2023. While the primary principles of QRM in this new version remain consistent with the original 2005 document, the revised guidance has four new subsections. This article examines the topics of formality and risk-based decisions.
-
New EU Directive Marks Cybersecurity Regulatory Paradigm Shift For Bio/Pharma & Medical Devices
2/15/2023
The EU's new Directive 2022/2555 on the Security of Network and Information Systems (“NIS2”) mandates cybersecurity risk management measures and reporting requirements for all segments of our industry, including labs; CROs and CDMOs; and manufacturers of APIs, bio/pharmaceuticals, and medical devices.
-
Our Weather Forecast For Medtech Business In 2023
2/8/2023
We outline the key medtech takeaways from the Annual J.P. Morgan Healthcare Conference held in January, as well as the medtech trends that we will be watching this year.
-
The 8 Key Takeaways For FDA Inspections In The Food And Drug Omnibus Reform Act
2/7/2023
With President Biden’s signature, the Food and Drug Omnibus Reform Act of 2022 (FDORA), part of the larger Consolidated Appropriations Act of 2023, became law on Dec. 29, 2022. FDORA expands and modifies the inspection authority of the FDA in several key areas, including alternative tools to inspection, mutual recognition agreements, bioresearch monitoring, and more.
-
3 Lessons U.S. Healthtech Companies Can Learn From The Cerebral Investigations
2/6/2023
Regulatory oversight and scrutiny of healthtech companies has emerged as a priority for the U.S. federal government. Facing triple investigations by the Federal Trade Commission (FTC), Department of Justice (DOJ), and Drug Enforcement Administration (DEA), Cerebral has become a cautionary tale for healthtech companies looking to provide telemedicine services across the U.S.
-
EU MDR Now Regulates Beauty Devices As Medical Devices
1/27/2023
The EU Regulation 745/2017 on medical devices (EU MDR) lists in Annex XVI several beauty devices that the EU Commission wants to regulate as medical devices, including colored contact lenses, cosmetic implants, cosmetic fillers, liposuction, light emitting equipment for skin resurfacing and other purposes, and brain stimulation devices.
-
The FDA & EU IVDR Regulatory Frameworks For IVD SaMD
1/4/2023
Software that is qualified as an in vitro diagnostic medical device (known as SaMD IVD) is affected by the same requirements as other medical devices, which are governed by various FDA regulations and EU In Vitro Diagnostic (IVD) Regulation EU 2017/746.
-
Does The FDA Or EU IVDR Consider IVD Software An IVD Medical Device?
12/16/2022
Software with a medical intended use can be embedded as part of a medical device, or it can also be considered a medical device by itself and regulated as Software as a Medical Device (SaMD). In vitro diagnostic devices are known as IVD SaMD. This article summarizes the regulatory requirements in the EU, governed by the In Vitro Diagnostics Regulation (IVDR), and the requirements in the U.S., governed by the FDA.