The FDA has released a draft guidance for an alternative to its traditional medical device reporting (MDR) program — the voluntary malfunction summary reporting (VMSR) program — which eases the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.
The Medical Device Coordination Group (MDCG) has released a new position paper, which reviews the means by which Article 97 of the Medical Device Regulation (MDR) can be applied to devices that have not been certified under the MDR. The paper states that the decision on whether to allow a device to remain on the market is up to the competent authority (CA) of record for the device, and that the device manufacturer may have only a one-year grace period before it will have to obtain a new marketing authorization under the MDR.
Many expected the FDA pilot program for software precertification to be a potential solution to many of the problems with the agency’s regulation of software as a medical device (SaMD). Unfortunately, it appears the precertification pilot was less than successful in providing a new regulatory path forward.
The latest draft guidance from the International Medical Device Regulators Forum (IMDRF) indicates that verification and validation (V&V) of the medical device production system (MDPS) is a complex matter, as is the question of who assumes the regulatory responsibility for the maintenance and use of these systems.
The International Medical Device Regulators Forum has produced a final working draft for verification and validation (V&V) of a personalized medical device (PMD), a much-needed source of regulatory harmonization. The document also addresses V&V for the medical device production system (MDPS) that will be used to manufacture PMDs.
Most FDA final guidances offer little more than a modest rewrite of the draft, but the FDA’s final guidance for clinical decision support (CDS) software represents a significant revision of the draft version. The changes seen in the final guidance may alter the regulatory status of both existing and developmental products, and developers of CDS software may wish to reevaluate their products in light of this new guidance.
Thanks to an ongoing controversy over computer system validation (CSV) for non-device software, the FDA draft guidance for computer software assurance (CSA) might be one of the most widely anticipated drafts to come out of the agency in several years. The key point is that the FDA explicitly acknowledges that software used in production and compliance systems does not necessarily present a high degree of risk, a key concession for those who believe the standing approach to compliance is often a case of regulatory overkill.
The FDA has posted a draft guidance for pharmaceutical analytical procedure development by the International Council for Harmonisation (ICH), which is accompanied by a draft guidance for validation of those analytical procedures. This Q14 analytical procedure development draft takes up the question of how analytical technologies can be managed as part of the production process lifecycle change management, and thus the overarching intent is to provide a set of principles that help to ensure that drug product quality remains high in a cost-effective manner.
Electronic Quality Management System
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