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2017-12-15 717  

Obstetrical and Gynecological Devices; Reclassification of Single-Use Female Condom, To Be Renamed Single-Use Internal Condom

The Food and Drug Administration (FDA) is proposing to reclassify single-use female condoms, renaming the device to “single-use internal condom,” a postamendments class III device (product code MBU), into class II (special controls) subject to premarket notification (510(k)). FDA is also identifying the proposed special controls that the Agency believes are necessary to provide a reasonable assurance of safety and effectiveness of the device. FDA is proposing this reclassification on its own initiative based on new information. FDA is also proposing to amend the existing device identification for “female condom,” a preamendments class III device (product code OBY), by renaming the device “multiple-use female condom,” to distinguish it from the “single-use internal condom.” If finalized, this order will reclassify single-use female condoms from class III to class II and reduce regulatory burdens on industry as these types of devices will no longer be required to submit a premarket approval application (PMA) but can instead submit a less burdensome 510(k) before marketing their device.

FDA는 “single-use female condoms”을 “single-use internal condom” 으로 개칭하고, 클래스 3(product code MBU) 에서 시판 전 신고(510(k)) 클래스 2로 바꾸는 일을 추진 중이다.

또한 해당 기기의 안전과 효율성 입증을 위해 필요한 special controls 을 검토 중에 있습니다.

FDA는 새로운 정보에 기반을 두어 이 재분류를 추진하고 있으며, 클래스 3(product code OBY)의 “female condom"을 “multiple-use female condom”으로 개칭함으로써 “single-use internal condom” 과의 차이를 둘 예정이다.

만약 이것이 통과된다면, “single-use female condoms“이 클래스 3에서 클래스 2로 변경됨으로써 시판 전 승인(PMA) 대신, 부담이 적은 510(k)만 제출하면 되기 때문에 제조사들의 규제 부담 또한 줄어들 것이다.

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