Last synced on 12 August 2022 at 11:05 pm

Inhaler, Metered Dose Or Dry Powder, Cder Or Cber Led

Page Type
Product Code
Definition
Metered Dose Inhaler and Dry Powder Inhalers are products that deliver drug substance to the site of action through the inhalation route
Physical State
Metered Dose Inhaler and Dry Powder Inhalers are products that deliver drug substance to the site of action through the inhalation route
Technical Method
Metered Dose Inhaler and Dry Powder Inhalers are products that deliver drug substance to the site of action through the inhalation route
Target Area
Inhalation
Review Panel
Anesthesiology
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 QKS is assigned to devices that are "not-classified", it is not linked to any specific regulation and CFR section.

Inhaler, Metered Dose Or Dry Powder, Cder Or Cber Led

Page Type
Product Code
Definition
Metered Dose Inhaler and Dry Powder Inhalers are products that deliver drug substance to the site of action through the inhalation route
Physical State
Metered Dose Inhaler and Dry Powder Inhalers are products that deliver drug substance to the site of action through the inhalation route
Technical Method
Metered Dose Inhaler and Dry Powder Inhalers are products that deliver drug substance to the site of action through the inhalation route
Target Area
Inhalation
Review Panel
Anesthesiology
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 QKS is assigned to devices that are "not-classified", it is not linked to any specific regulation and CFR section.