Last synced on 27 January 2023 at 11:04 pm

System, Intravaginal, For Controlled Release Of Drug Substance, Cder Or Cber Led

Page Type
Product Code
Definition
Intravaginal systems for controlled release of drug substance are products that are inserted into the vagina and provide controlled release of drug products
Physical State
Intravaginal systems for controlled release of drug substance are products that are inserted into the vagina and provide controlled release of drug products
Technical Method
Intravaginal systems for controlled release of drug substance are products that are inserted into the vagina and provide controlled release of drug products
Target Area
Vagina
Review Panel
Obstetrical and Gynecological
Submission Type
Contact ODE
Device Classification
N
GMP Exempt?
No
Summary Malfunction Reporting
Ineligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

No Linked CFR Text

As product code QLH is assigned to devices that are "not-classified", it is not linked to any specific regulation and CFR section.

System, Intravaginal, For Controlled Release Of Drug Substance, Cder Or Cber Led

Page Type
Product Code
Definition
Intravaginal systems for controlled release of drug substance are products that are inserted into the vagina and provide controlled release of drug products
Physical State
Intravaginal systems for controlled release of drug substance are products that are inserted into the vagina and provide controlled release of drug products
Technical Method
Intravaginal systems for controlled release of drug substance are products that are inserted into the vagina and provide controlled release of drug products
Target Area
Vagina
Review Panel
Obstetrical and Gynecological
Submission Type
Contact ODE
Device Classification
N
GMP Exempt?
No
Summary Malfunction Reporting
Ineligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

No Linked CFR Text

As product code QLH is assigned to devices that are "not-classified", it is not linked to any specific regulation and CFR section.