The FDA’s draft guidance for predetermined change control plans (PCCPs) is months away from conversion into a final guidance, but that hasn’t stopped software developers from creating products with a PCCP component for the U.S. market. The FDA approved the de novo application by Caption Health on Feb. 24, 2023, for a machine learning (ML) product that processes ultrasound images to calculate left ventricular ejection fraction (LVEF).
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.
A new guidance from the Medical Device Coordination Group (MDCG) clarifies that software as a medical device (SaMD) product can operate under a limited amount of regulatory oversight when deployed only in a single healthcare entity, which gives smaller developers an opportunity to gain a foothold in the European Union (EU) while they add to their to-market capabilities.
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.
The latest draft guidance from the International Medical Device Regulators Forum (IMDRF) indicates that verification and validation (V&V) of the medical device production system (MDPS)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.
The FDA has released a second guidance from the International Council for Harmonization (ICH) related to analytical methods used in drug products, which is open for comment through Sept. 28, 2022. This latest version of the ICH Q2 series of guidances offers substantially greater detail than the previous version, suggesting that managers of drug manufacturing facilities should begin examining this policy on analytical methods validation to ensure the facility is prepared for the final version.
The European Union has undertaken several measures to address the difficulty of implementing the Medical Device Regulation (MDR), but these grace periods are coming to an end. The EU’s Medical Device Coordination Group (MDCG) recently advised medical device manufacturers that time is running out to reapply for a CE mark for existing devices in a position paper that serves as a warning that stragglers may be left out in the transition.
Electronic Quality Management System
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