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.
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The latest draft guidance from the International Medical Device Regulators Forum (IMDRF) indicates that verification and validation (V&V) of the medical device production system (MDPS)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Thanks to an ongoing controversy over computer system validation (CSV) for non-device software, the FDA draft guidance for computer software assurance (CSA) might be one of the most widely anticipated drafts to come out of the agency in several years.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 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 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.
The FDA has reissued draft guidance for premarket cybersecurity considerations four years after the previous draft guidance, and eight years after the issuance of the most recent final guidance. While this draft guidance is not the final word on this policy, we would advise our clients that it represents a fundamental shift in the agency’s approach to cybersecurity, one that comes with a substantially more demanding set of requirements in the premarket phase of device development.
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
