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Received 29 May 2018, Revised 2 November 2018, Accepted 2 November 2018, Available online 14 November 2018., Medical devices are under strict regulatory oversight worldwide and such regulations prioritise patient safety and efficacy over anything else. Contact lenses fall under the medical device category - a result of direct contact with the eye. Equally regulated are the contact lens care product solutions, which include cleaning and maintenance solutions and lubricating and rewetting drops. In the USA, it is the FDA Centre for Devices and Radiological Health (CDRH) overseeing the regulations of medical devices, since 1976. In the European Union, it is the EU Commission responsible for regulating devices in Member States. The categorisation of contact lenses into medical devices is based on their inherent risk to the wearer. Contact lenses are subject to crucial regulatory oversight from concept to clinical evaluation, clinical investigations through to the finished lens product, and finally, strict conditions associated with their marketing approval including post-marketing surveillance. The physiochemical and manufacturing testing, such as biocompatibility testing alongside pre-clinical stability, sterility and microbiological testing are just some of the essential testing lenses must endure. Only through understanding the inherent risks and potential complications that can arise from contact lens wear, can one truly appreciate the need to adhere to strict regulations. The challenge however, lies in the need for more standardised regulations and flexible approaches, ensuring innovative device technologies reach patients in a timely manner without compromising public health and safety. This review highlights some key requirement, differences and similarities between the FDA and EU administrations in the approval of contact lenses., Unión Europea. H2020, Depto. de Optometría y Visión, Fac. de Óptica y Optometría, TRUE, pub

Mice are increasingly used in vascular research for studying perturbations and responses to vasoactive agents in small artery preparations. Historically, small artery function has preferably been studied in rat isolated mesenteric resistance-sized arteries (MRA) using the wire myograph technique. Although different mouse arteries have been studied using the wire myograph no establishment of optimal settings has yet been performed. Therefore, the purposes of this study were firstly to establish the optimal settings for wire myograph studies of mouse MRA and compare them to those of rat MRA. Second, by surveying the literature, we aimed to evaluate the overall translatability of observed pharmacological vasomotor responses of mouse MRA to those obtained in rat MRA as well as corresponding and different arteries in terms of vessel size and species origin. Our results showed that the optimal conditions for maximal active force development in mouse MRA were not significantly different to those determined in rat MRA. Furthermore, we found that the observed concentration-dependent vasomotor responses of mouse MRA to noradrenaline, phenylephrine, angiotensin II, sarafotoxin 6c, 5-hydroxytryptamine, carbachol, sodium nitroprusside, and retigabine were generally similar to those described in rat MRA as well as arteries of different sizes and species origin. In summary, the results of this study provide a framework for evidence-based optimization of the isometric wire myograph setup to mouse MRA. Additionally, in terms of translational value, our study suggests that mouse MRA can be applied as a useful model for studying vascular reactivity.