For a Drug-Device Combination Product, 'Design Control' Process is triggered at?

V

v9991

Trusted Information Resource
#1
#1
As clarified in the the referenced FDA PPT,"Design Controls"

Design Controls - When to Start?
• Where research ends and design begins
• After Feasibility/“Proof of Concept”
• When you plan to bring your device to market
• Prior to start of any Investigation Device Exemption
(21 CFR 812)
• Premarket
• Mechanism of change/revision
Click to expand...
Above statement is pretty self explanatory for an new-product/drug. My query is about interpreting it for an 'GENERIC / ANDA' product;

Because, the feasibility is already established by innovator/NDA_holder; hence, when a generic drug manufacturing starts development, at what stage does the 'design control' start. (typical starting steps are with an prototype, and pilot study)
 
GAGEpack - Gage & Calibration Management
Elsmar Forum Sponsor
Ronen E

Ronen E

Problem Solver
Moderator
#2
#2
v9991 said:
As clarified in the the referenced FDA PPT,"Design Controls"



Above statement is pretty self explanatory for an new-product/drug. My query is about interpreting it for an 'GENERIC / ANDA' product;

Because, the feasibility is already established by innovator/NDA_holder; hence, when a generic drug manufacturing starts development, at what stage does the 'design control' start. (typical starting steps are with an prototype, and pilot study)
Click to expand...
A lot of companies do feasibility studies on "me too" devices as well. The fact that it's no longer novel for the original inventor doesn't mean that another org doesn't need a "research phase" before that can wrap their heads around it, and build confidence in technological and economical viability of the endeavour.

On the other hand, if feasibility is much of a no-brainer, and there's a clear intention to go to market with the outcome, I'd say design controls should apply from the get-go.
 
Last edited:
Statistical Steven

Statistical Steven

Statistician
Leader
Super Moderator
#3
#3
First design controls are for the DEVICE, not the generic drug. Though the device and generic, each individually have been cleared, your design control studies are about the drug/device combination. So you are looking at bio-compatibility, drug delivery requirements, usability with your drug, etc.



v9991 said:
As clarified in the the referenced FDA PPT,"Design Controls"



Above statement is pretty self explanatory for an new-product/drug. My query is about interpreting it for an 'GENERIC / ANDA' product;

Because, the feasibility is already established by innovator/NDA_holder; hence, when a generic drug manufacturing starts development, at what stage does the 'design control' start. (typical starting steps are with an prototype, and pilot study)
Click to expand...
 
V

v9991

Trusted Information Resource
#4
#4
one other question, at what time do we require to have "GMPs" around the 'data' generated at various stages. ( design inputs - outputs etc stages)

is it required to have GMP systems around 'design inputs' stage onwards?
typically for an ANDA product, D-inputs involve reverse engineering from reference product; etc., and they typically get evolved over period of time.

and I believe that design-verification and design-validation certainly require GMPs.

pl. help clarify.
 
You must log in or register to reply here.
Thread starter Similar threads Forum Replies Date
M Drug-Device Combination product CE Marking (Conformité Européene) / CB Scheme 1
N Is this a single integral drug device combination product EU MDR CE Marking (Conformité Européene) / CB Scheme 1
K Release testing for Combination Drug-Medical Device Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 0
V Upgrading Systems from CFR 211 to CFR 820 (drug+device combination) 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 7
O Experience with IMB as Competent Authority of Drug Device Combination Products? EU Medical Device Regulations 5
T Clinical trial - Medical device product not cleared (without FDA approval) in a drug trial Other US Medical Device Regulations 9
V Informational EMA - Quality requirements for drug-device combinations EU Medical Device Regulations 0
M Informational Health Canada – Drug and medical device highlights 2018: Helping you maintain and improve your health Medical Device and FDA Regulations and Standards News 1
M FDA News USFDA Final Rule – Medical Device Classification Procedures: Incorporating Food and Drug Administration Safety and Innovation Act Procedures Medical Device and FDA Regulations and Standards News 0
A Russia- Medical device with drug registration Other Medical Device Regulations World-Wide 0
D Risk Management for Drug-Device Combinations ISO 14971 - Medical Device Risk Management 1
E Operational Qualification of a Drug Box Coding Device in Production Other Medical Device and Orthopedic Related Topics 1
A Comparing US/FDA Drug Regulations against US/FDA Device Regulations US Food and Drug Administration (FDA) 3
S ANOVA and Test Method Validation for a Drug Delivery Device Statistical Analysis Tools, Techniques and SPC 4
S US FDA (Food and Drug Administration) Medical Device User Fees for 2013 Other US Medical Device Regulations 4
somashekar Fake Drug Identifier - Would this device be termed a Medical Device? Medical Information Technology, Medical Software and Health Informatics 5
Ajit Basrur FDA Guidance - Heparin for Drug and Medical Device Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 1
E Classification (Medical Device or Drug) of Blood Bag in Japan Japan Medical Device Regulations 6
bio_subbu European Medicines Agency Seeks Comments on Drug/device Consultation Process EU Medical Device Regulations 0
H Drug Device Submission: Is a Technical File required Other Medical Device and Orthopedic Related Topics 6
M Medical Device Makers - Louisiana Wholesale Drug Distribution Rules Various Other Specifications, Standards, and related Requirements 1
Y Draft FDA Guidance on "Presenting Risk Information in Prescription Drug and Device" US Food and Drug Administration (FDA) 1
B Drug Device combinations - Drug degradation and impurities Other Medical Device and Orthopedic Related Topics 2
V Regulatory consultants for US FDA ANDA - pharma / drug products Consultants and Consulting 0
G RAC Drug 2023 Spring Preparation General Information Resources 0
M DHF for drug products Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 0
P Looking for Korean FDA Drug Master File requirements for packaging systems. Other Medical Device and Orthopedic Related Topics 1
H OTC DRUG Private Labelling Distributor: GMP REQUIREMENT ISO 13485:2016 - Medical Device Quality Management Systems 0
M How to Develop a Sampling Plan for Drug Substance? Inspection, Prints (Drawings), Testing, Sampling and Related Topics 0
D CFR Title 14: Aeronautics and Space PART 120—DRUG AND ALCOHOL TESTING PROGRAM Federal Aviation Administration (FAA) Standards and Requirements 3
Q Legal Manufacturer OTC Drug Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 0
D CE Marked product considered a Drug in India Other Medical Device Regulations World-Wide 0
M Workplace Drug Testing in 2020 Misc. Quality Assurance and Business Systems Related Topics 19
D Requirement of Pharmacovigilance (Drug Safety) Risk Based Strategic and Tactical Audit Plan General Auditing Discussions 0
K Comparator drug with Japanese label use in Clinical trials? US Food and Drug Administration (FDA) 0
S Do we need to validate Software used in Drug discovery and development process? Qualification and Validation (including 21 CFR Part 11) 2
O Validation approach for a Photostability Chamber (used for fluid therapy and injectable drug products) Qualification and Validation (including 21 CFR Part 11) 1
M Informational MHRA Guidance – Recommendations from the independent Expert Advisory Group on the use of Paclitaxel Drug-Coated Balloons (DCBs) and Drug-Eluting Stent Medical Device and FDA Regulations and Standards News 0
D FDA filing guidance to add sterilization step for approved drug Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 8
S Should the primary drug containers be molded in ISO Class 7 clean room? Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 6
P Drug packaging / filling operations Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 8
P China drug packaging DMF China Medical Device Regulations 0
H Korea DMF (Drug Master File) Fees Various Other Specifications, Standards, and related Requirements 5
Y What Clinical Data is required for Drug Delivery System EU Medical Device Regulations 1
P DMF (Drug Master File) type V for Sterilization Processes for USFDA Submission Other US Medical Device Regulations 3
Y Shelf Life of Non-Sterile Disposable Drug Inhaler 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
V Design Controls for Combination Drug Product Manufacturer (ANDA) 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
L Registration of an Imported Medical Drug in Turkey Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 1
R Holding time stability study of intermediates of drug substances US Food and Drug Administration (FDA) 2
S Korea - MFDS (South Korea Ministry of Food and Drug Safety) Contact? Other Medical Device Regulations World-Wide 10

Similar threads

Top Bottom