Obstetrical And Gynecological Devices; Reclassification Of ...

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Obstetrical And Gynecological Devices; Reclassification Of ...

The Food and Drug Administration (FDA or the Agency) is issuing a final order to reclassify single. use internal condom,'' a postamendments class III device (regulated under product code MBU), into class II (special controls) subject to premarket.

Abstract Essence

[the] [of] [and] [to] [use] [is] [device] [that] [FDA] [a] [condoms] [internal] [in] [for] [single] [effectiveness] [C] [class] [be] [or] [under] [controls] [Act] [The] [are] [21] [order] [on] [condom] [special] [CFR] [FD] [not] [as] [devices] [section] [information] [with] [II] [safety] [reclassification] [from] [premarket] [513] [an] [must] [by] [this] [proposed] [have] [commenter] [Agency] [III] [”] [provide] [part] [reasonable] [assurance] [3] [contraceptive] [failure] [Food] [female] [into] [2018] [This] [510] [study] [male] [Drug] [4] [notification] [k] [believes] [based] [can] [f] [evidence] [clinical] [Response] [commenters] [should] [control] [modes] [Federal] [Single] [final] [A] [884] [its] [because] [intended] [1] [been] [2] [scientific] [which] [approved] [comments] [5]