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.
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).
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.
The FDA has released a draft guidance for an alternative to its traditional medical device reporting (MDR) program — the voluntary malfunction summary reporting (VMSR) program — which eases the burden of post-market surveillance for a large number of device types.
A recent FDA guidance on human factors engineering (HFE) provides some crucial insights into the agency’s expectations for premarket submissions, but appropriate planning in the early stages of product development can go a long way toward making HFE an asset in development of products.
The European Commission (EC) has proposed to extend the transition period for medical devices under the Medical Device Regulation (MDR), a proposal which must go through several more steps before full legal adoption.
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