← FDA Medical Device Classifications

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

Market data

Cleared 510(k) submissions
0
Registered establishments
0

Source

Authoritative
FDA Device Classification database
Machine
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