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February 13, 2023
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FDA’s Extended Reality Program Seeks Answers to Scientific Questions
February 7, 2023
The field of augmented reality/virtual reality (AR/VR) is the subject of nearly 40 FDA marketing authorizations in the past few years, but this is still a relatively unexplored technological area. The FDA’s medical extended reality (MXR) program was established in 2021 to address some of the deficits in methods for validating AR/VR products.
FDA Guidance Documents are Vital in De-Risking REMS
February 2, 2023
The FDA’s risk evaluation and mitigation strategy (REMS) requirements are among the most demanding of a pharmaceutical or biotech manufacturer’s postmarket requirements, and it is important to plan adequately for these programs, given the cost of a failed first attempt.
Human Factors Engineering a Demanding but Vital Requirement
January 24, 2023
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.
Extension of MDR Transition Proposed by European Commission
January 17, 2023
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.
MDCG Proposes a Potential One-Year Extension for Medical Devices
January 10, 2023
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.
FDA Pilot SaMD Precertification Program Offers Few Insights
December 13, 2022
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.
Medical Device Production Systems a Significant Regulatory Undertaking
December 6, 2022
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.
IMDRF Issues Two-Part Guidance for Personalized Medical Devices
November 29, 2022
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.
FDA Final Guidance for CDS a Drastic Rewrite of Draft
October 19, 2022
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.
Electronic Quality Management System
Enzyme eQMS is flexible and scalable, making it easy to use for startups, yet configurable to meet the needs of the most complex enterprise
