Mapping the genealogy of medical device predicates in the United States

Background In the United States, medical devices are regulated and subject to review by the Food and Drug Administration (FDA) before they can be marketed. Low-to-medium risk novel medical devices can be reviewed under the De Novo umbrella before they can proceed to market, and this process can be fairly cumbersome, expensive, and time-consuming. An alternate faster and less-expensive pathway to going to market is the 510(k) pathway. In this approach, if the device can be shown to be substantially equivalent in safety and effectiveness to a pre-existing FDA-approved marketed device (or “predicates”), it can be cleared to market. Due to the possibility of daisy-chaining predicate devices, it can very quickly be difficult to unravel the logic and justification of how a particular medical device’s equivalence was established. From patients’ perspective, this minimizes transparency in the process. From a vendor perspective, it can be difficult to determine the right predicate that applies to their device. Methods We map the connectivity of various predicates in the medical device field by applying text mining and natural language processing (NLP) techniques on data publicly made available by the FDA 78000 device summaries were scraped from the US FDA 510(k) database, and a total of 2,721 devices cleared by the 510(k) regulatory pathway in 2020 were used as a specific case study to map the genealogy of medical devices cleared by the FDA. Cosine similarity was used to gauge the degree of substantial equivalence between two medical devices by evaluating their device descriptions and indications for use. Recalls and complaints for predicate devices were extracted from the FDA’s Total Product Life Cycle database using html scraping and web page optical character recognition to determine the similarity between class 1 recalled devices (the most severe form of device recall) and other substantially equivalent devices. A specific product code was used to illustrate the mapping of the genealogy from a De Novo device. Results and discussion The ancestral tree for the medical devices cleared in 2020 is vast and sparse, with a large number of devices having only 1–2 predicates. Evaluation of substantial equivalence data from 2003–2020 shows that the standard for substantial equivalence has not changed significantly. Studying the recalls and complaints, shows that the insulin infusion pump had the highest number of complaints, yet none of the recalled devices bore significant degree of text similarity to currently marketed devices. The mapping from the De Novo device case study was used to develop an ancestry map from the recalled predicate (recalled due to design flaws) to current substantially equivalent products in the market. Conclusions Besides enabling a better understanding of the risks and benefits of the 510(k) process, mapping of connectivity of various predicates could help increase consumer confidence in the medical devices that are currently in the marketplace.

‘Ξένο’ DNA από τη χορηγούμενη τροφή στον οργανισμό των ζώων και αξιολόγηση της ασφάλειας των γενετικώς τροποποιημένων ζωοτροφών

The paper starts with the significance of biotechnology for animal nutrition, focusing on transgenic plants where most of genetically modified feedstuffs are. In addition, the significance of genetically modified-plants as animal feeds and the requirement for this crucial issue to be covered by European Union legislation is discussed, since the top cereal and oil-seed crops worldwide, i.e. maize and soya bean, respectively, as well as cottonseed and rapeseed, are within this category of raw materials. The procedure for authorisation of genetically modified feeds in the EU is also discussed. Moreover, various aspects referring to degradation of ‘foreign’ dietary DNA fragments from transgenic plants in the animal’s organism are reviewed. Transfer of DNA from genetically modified crops to the animal’s body and the animal products is also considered. In order to discuss the nutritional quality of genetically modified feeds in animal diets, the term ‘substantial equivalence’ was introduced, referring to the same chemical composition in content of nutrient and undesirable contents, when comparing conventional with genetically modified-dietary ingredients.The debate over ‘substantial equivalence’ principle is also reviewed; this made validity of the procedure in relation to safety evaluation less significant. Safety evaluation procedure of genetically modified-feeds (particularly, herbicide-tolerant and insect-resistant maize) by the official EU procedure, where risk assessment is performed by EFSA and risk management and communication by the Commission, is also discussed. Safety evaluation of genetically modified feeds examines aspects, such as: molecular characterisation, comparative composition analysis with conventional counterparts and nutritional assessment covering toxicology and allergenicity. With reference to environmental implications, certain aspects on post-market environmental monitoring of genetically modified feeds, (e.g., biodiversity, mitigation measures, surveillance plan), are considered.