Last synced on 9 May 2025 at 11:05 pm

Material, Implantable For Controlled Release, Cder Or Cber Led

Page Type
Product Code
Definition
Implantable material for controlled release of drug substance.
Physical State
Implantable material for controlled release of drug substance.
Technical Method
Implantable material for controlled release of drug substance.
Target Area
Implantable material for controlled release of drug substance.
Review Panel
General Hospital
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 QIZ is assigned to devices that are "not-classified", it is not linked to any specific regulation and CFR section.

Material, Implantable For Controlled Release, Cder Or Cber Led

Page Type
Product Code
Definition
Implantable material for controlled release of drug substance.
Physical State
Implantable material for controlled release of drug substance.
Technical Method
Implantable material for controlled release of drug substance.
Target Area
Implantable material for controlled release of drug substance.
Review Panel
General Hospital
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 QIZ is assigned to devices that are "not-classified", it is not linked to any specific regulation and CFR section.