A review of international medical device regulations: Contact lenses and lens care solutions

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dc.contributor.authorZaki, Marina
dc.contributor.authorPardo, Jesús
dc.contributor.authorCarracedo Rodríguez, Juan Gonzalo
dc.date.accessioned2023-06-17T13:19:49Z
dc.date.available2023-06-17T13:19:49Z
dc.date.issued2018-11-14
dc.descriptionReceived 29 May 2018, Revised 2 November 2018, Accepted 2 November 2018, Available online 14 November 2018.
dc.description.abstractMedical 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.
dc.description.departmentDepto. de Optometría y Visión
dc.description.facultyFac. de Óptica y Optometría
dc.description.refereedTRUE
dc.description.sponsorshipUnión Europea. H2020
dc.description.statuspub
dc.eprint.idhttps://eprints.ucm.es/id/eprint/51273
dc.identifier.doi10.1016/j.clae.2018.11.001
dc.identifier.issn1367-0484
dc.identifier.officialurlhttps://doi.org/10.1016/j.clae.2018.11.001
dc.identifier.relatedurlhttps://www.sciencedirect.com/science/article/pii/S1367048418307951
dc.identifier.urihttps://hdl.handle.net/20.500.14352/13101
dc.journal.titleContact Lens and Anterior Eye
dc.language.isoeng
dc.page.initial11 p.
dc.publisherElsevier
dc.relation.projectID3D NEONET (734907)
dc.rights.accessRightsopen access
dc.subject.cdu681.73
dc.subject.cdu617.7-089.243
dc.subject.keywordClinical investigation
dc.subject.keywordMarket approval
dc.subject.keywordContact lenses
dc.subject.keywordCare solutions
dc.subject.keywordClinical evaluation
dc.subject.ucmLentes de contacto
dc.subject.ucmÓptica oftálmica
dc.subject.unesco3311.11 Instrumentos ópticos
dc.titleA review of international medical device regulations: Contact lenses and lens care solutions
dc.typejournal article
dspace.entity.typePublication
relation.isAuthorOfPublication97433353-d31b-4cf5-b2c0-47d2e6703fe5
relation.isAuthorOfPublication.latestForDiscovery97433353-d31b-4cf5-b2c0-47d2e6703fe5
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