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국제 의료 장비 규제: 콘택트 렌즈와 렌즈 관리 솔루션에 대한 리뷰.

PMID: 30446241 · 2018-11-14

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학술지Contact lens & anterior eye : the journal of the British Contact Lens Association

연도2018-11-14

PMID30446241

초록

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 medi

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