Home 醫材法規美國醫材 【產品指引】日戴型軟式隱形眼鏡的新510(k)送審指引(草案)

【產品指引】日戴型軟式隱形眼鏡的新510(k)送審指引(草案)

by 愛姆斯

愛姆斯知道隱形眼鏡產業在台灣醫材界算是很大的一個群體,所以昨天看到熱騰騰的新指引時就想發這一篇了,但MDR系列文太重要了,所以優先處理。現在回到這個精采的指引吧!

重溫安全性能510(k)
首先,我們要先複習什麼是安全性能510(k),所以我們來複習愛姆斯法規世界之前對此新類型指引的介紹(請點這裡)

新指引在講什麼?
指引名稱:
Soft (Hydrophilic) Daily Wear Contact Lenses – Performance Criteria for Safety and Performance Based Pathway

對於這種新的安全性能510(k),有了概念以後,我們回頭來看看這個最新的隱形眼鏡指引此指引為安全性能510(k)發佈以來,第5個產品相關指引。主要適用對像是日戴軟式隱形眼鏡。在FDA的分類如下:
醫材名: The soft (hydrophilic) daily wear contact lenses
分級: II級醫材
法源: 21 CFR 886.5925
產品碼: LPL.

此指引告訴廠商針對軟式日戴型隱形眼鏡的安全性能510(k)的要求。完成指引內的要求和測試以支持實質等效後,採安全性能送審可以免除和Predicate device的性能比對。

不適用情形
請注意若產品的用途及適應症落在以下情形,則不適用此安全性能指引:
· To correct presbyopia
· To enhance or alter the apparent color of the eye· To act as a bandage or therapeutic lens
· For the management of keratoconus or irregular corneal conditions
· Lenses with special optical performance beyond that of correcting ametropia (e.g., blue 102 light filtering)
· Lenses with special physical performance (retains moisture, lubricates, reduces deposits)
· Lenses with special health performance characteristics (e.g., relieves dry eye)

要測什麼?
此指引主要在建議需要做的14個測試項目(細節請看指引內容)

物理化學及眼科性質Physicochemical and Optical Properties

  1. Test name: Spectral Transmittance (%)
  2. Test name: Ultra Violet (UV) Transmittance (%)
  3. Test name: Refractive Index
  4. Test name: Water Content (%)
  5. Test name: Specific Gravity
  6. Test name: Oxygen Permeability (Dk or [cm2 233 /s][ml O2/ml x mmHg])
  7. Test name: Extractables (< 1% with water and hexane)

機械性質Mechanical Properties

  1. Test name: Modulus (MPa or N/mm2)
  2. Test name: Tensile Strength (MPa or N/mm2)
  3. Test name: Elongation at Break (%)

包裝Packaging Solution

  1. Test name: Packaging Solution pH
  2. Test name: Packaging Solution Osmolality (osmol/kg)

滅菌消毒Sterilization

  1. Test name: Sterilization (devices labeled as sterile)

生物相容Biocompatibility

  1. Test name: Biocompatibility endpoints (identified from CDRH Biocompatibility Guidance)

參考:
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/soft-hydrophilic-daily-wear-contact-lenses-performance-criteria-safety-and-performance-based-pathway

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