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



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Zaki, Marina and Pardo, Jesús and Carracedo Rodríguez, Juan Gonzalo (2018) A review of international medical device regulations: Contact lenses and lens care solutions. Contact Lens and Anterior Eye . 11 p.. ISSN 1367-0484

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Official URL: https://doi.org/10.1016/j.clae.2018.11.001


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.

Item Type:Article
Additional Information:

Received 29 May 2018, Revised 2 November 2018, Accepted 2 November 2018, Available online 14 November 2018.

Uncontrolled Keywords:Clinical investigation; Market approval; Contact lenses; Care solutions; Clinical evaluation
Subjects:Medical sciences > Optics > Contact lenses
Medical sciences > Optics > Visual perception
ID Code:51273
Deposited On:18 Feb 2019 16:31
Last Modified:27 Feb 2019 13:16

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