An updated guidance from the Medical Device Coordination Group (MDCG) explains the modifications that can be made to devices certified under the legacy regulatory system without rendering the device ineligible for the EU market.
ENZYME BLOGAnalyzing the latest developments in regulatory, compliance, and quality
Medical DevicesSaMDMay 10, 2023
IMDRF Legacy Device Cybersecurity Guidance Highlights Need for Proactivity
One of the essential elements of this guidance is that the end-of-life/end-of-service (EOL/EOS) declaration for a software or firmware component can precipitate the same state for the medical device manufacturer’s (MDM’s) product, a problem that must be dealt with in advance to ensure that the MDM is not forced to prematurely withdraw its medical device.
While SBOMs may not fundamentally change your perspective on cybersecurity, they can be tremendously useful not just in managing cybersecurity across the total product life cycle (TPLC), but also in sustaining good relationships with customers and regulatory agencies.
Digital HealthMedical DevicesSaMDApril 27, 2023
Digital Tools Ease the Burden of Clinical Trial Monitoring
Clinical trial monitoring for FDA-regulated products can be expensive and troublesome, but digital health technologies (DHTs) can make the process less painful and more cost-efficient. However, in order for clinical trial sponsors to enjoy these benefits, proper planning and execution will be necessary, according to a new FDA guidance for clinical trial monitoring.
This short, 6-page guidance casts a long shadow across the medical device landscape. The guidance states that the agency will reject an application that fails to provide adequate cybersecurity measures in premarket applications — just one of several recent developments that show just how serious the U.S. federal government is about cybersecurity.
Artificial IntelligenceSaMDApril 12, 2023
FDA (Finally) Publishes Change Control Draft Guidance for Artificial Intelligence
Several features of this draft suggest companies will have to do a significant amount of work in the premarket phase for development of a predetermined change control protocol (PCCP), making the development process potentially lengthier and more expensive.
Artificial IntelligenceDigital HealthPharmaApril 5, 2023
FDA Takes Next Step Toward Digital Health in Drug Development
The FDA has released a framework for the use of digital health technologies (DHTs) in the development of pharmaceuticals and biologics, but the FDA’s Center for Devices and Radiological Health (CDRH) will be intimately involved in this project.
There is a growing — and disconcerting — trend in which FDA resorts to regulation and lawmaking by fiat, overstepping the authority granted to it by Congress. Of particular concern are recent actions taken in regard to clinical decision support (CDS) software and laboratory-developed tests (LDTs).
Artificial IntelligenceManufacturingPharmaMarch 21, 2023
FDA Discussion Paper Sees AI as Critical for Advanced Drug Manufacturing
The FDA has released a discussion paper on the use of artificial intelligence (AI) in the drug manufacturing process, raising a host of questions about issues such as the use of cloud services for manufacturing data management. Perhaps the key consideration posed by the paper is whether AI will enable the broad adoption of advanced drug manufacturing, which the FDA has been trying to encourage for nearly 20 years.
Clinical Decision SupportMedical DevicesMarch 14, 2023
CDS Coalition Seeks to Reverse FDA Final Guidance for CDS
The CDS Coalition has filed a citizen petition to have the FDA withdraw its final guidance for clinical decision support (CDS) software, a development that could prove essential to unlocking the market for these products.
Electronic Quality Management System
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