System, Intravaginal, For Controlled Release Of Drug Substance, Cder Or Cber Led
QLH · Not classified · Unknown
Classification
FDA Product Code
QLH
Device class
Not classified
Regulation
—
Review panel
OB
Medical specialty
Unknown
Submission type
3
GMP exempt
N
Life sustaining
N
Implant
N
Third-party review
N
Definition
Intravaginal systems for controlled release of drug substance are products that are inserted into the vagina and provide controlled release of drug products