Does 820.30 include the manufacturing process?

Watchcat

Trusted Information Resource
#1
I'm reacting to a claim that 820.30 "fundamentally and specifically demands that the responsible organization not only design the product, but also the manufacturing process."

There are really several claims here, all of which are news to me:

1. That 820.30 dictates who has to do the design work.
2. That it requires that the same organization that designed the product also design the manufacturing process. (Do you design a manufacturing process?)
3. That it is applicable to the manufacturing process.

All of this is outside my own scope of expertise. Nonetheless, I was very surprised to hear this, and wondered if some of the Covers who are experienced in this area could shed some light.
 
Elsmar Forum Sponsor

William55401

Involved In Discussions
#2
The manufacturing process owner / designer can be a separate entity from Design Authority. 820.30 (h) is Design Transfer and this QSR element ensures that design is translated into Production Specifications. There is a large world of Contract Manufacturing Organizations that take designs from customers and build the product. These CMOs develop the production specifications. The organization that places the product on the market (the legal manufacturer) is responsible for oversight on the CMO. The FDA establishment registration and listing website has Contract Manufacturer as an option you can search on.
 

Ronen E

Problem Solver
Staff member
Moderator
#3
1. That 820.30 dictates who has to do the design work.
When part 820 talks of the manufacturer's obligations it refers to responsibility, not to who actually does the work. The regulatory owner of record (AKA the "legal manufacturer") is responsible for design work and also (formally) for manufacturing. There are, however, precedents where a CM was held responsible - it can happen when the CM holds all the expertise and the (design) Specification Developer holds none or close to none. But like you pointed out in another thread FDA is not a monolith and also evolves over time, so I can't tell how relevant it is today.
2. That it requires that the same organization that designed the product also design the manufacturing process.
Not in the sense of actually doing the work. Yes in the responsibility sense.
(Do you design a manufacturing process?)
Yes.
3. That it is applicable to the manufacturing process.
Only in so far as it relates to developing the necessary, adequate manufacturing processes.
 
Thread starter Similar threads Forum Replies Date
M Does the Scope of 21 CFR Part 820.72 (Equipment) apply to Design? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
M Does a process map satisfy 21 CFR 820.20(d) (Quality Plan)? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
M FDA 21 CFR 820.250 - Does "valid statistical" always mean math? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 6
S Does FDA expect suppliers to be independently assessed to 21 CFR Part 820 ? US Food and Drug Administration (FDA) 4
M Does 21 CFR 820.80 (b) require a Supplier to have Receiving Inspection? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 13
I Does being a subsidiary fully absolve company B from complying with 21 CFR 820? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
A Does any one have FDA 21 CFR Part 820 QSR training material? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 13
K 820.180(b) Record Retention - Does it apply here? We act as the initial Importer 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
L Does 820.30 Design Controls apply to Unclassified Device with 510(k)? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 7
Q Does 21 CFR 820 really revise every year? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
sagai Required Documentation for 820.25(b) - What does "Training shall be documented" mean 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 15
C Does ISO 13485 certification require a company to follow 21 CFR Part 820? ISO 13485:2016 - Medical Device Quality Management Systems 13
A What does the FDA think about 13485? Will the FDA upgrade 21 CFR 820? ISO 13485:2016 - Medical Device Quality Management Systems 3
F Does anyone have an ESD quality/cooler talk to share? Training - Internal, External, Online and Distance Learning 4
A What does this line from MDCG 2020-3 (MDR art. 120 substantial change) mean to you? EU Medical Device Regulations 0
D Change Approval Requirements - Does every change need formal customer approval? Design and Development of Products and Processes 17
T What does AS9100 mean when it says you must establish a process to do X? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 24
L Does a backdate form format can be changed if wrong revision is used? Document Control Systems, Procedures, Forms and Templates 8
B General Motors and Honda Alliance - What does this mean to suppliers? IATF 16949 - Automotive Quality Systems Standard 3
C ISO 13485 :2016 - CAPA - Does every CAPA need to be checked by regulations? ISO 13485:2016 - Medical Device Quality Management Systems 9
A Does ISO 9001:2015 cover all the requirements of ISO 10012:2003? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
N FDA UDI - Label vs. Labeling - Does the insert need to include UDI? Other US Medical Device Regulations 0
A Does anyone have a checklist of API Spec 650 13th Edition? Oil and Gas Industry Standards and Regulations 0
D Does Manufacture can submit CE mark application under MDD with NB for his New product after May 2020? EU Medical Device Regulations 3
A What does this sentence "this symbol shall be used in the orientation shown" mean in ISO 780:2015? Other Medical Device Related Standards 4
L Turkish Requirements - Does the Software need to be translated? CE Marking (Conformité Européene) / CB Scheme 2
R Where does IATF 16949 address Process mapping? IATF 16949 - Automotive Quality Systems Standard 3
J Does Pakistan Medical Device Import License allows parallel import? Other Medical Device Regulations World-Wide 0
BeaBea Interesting Discussion Where Does Marketing/ Advertisement of Products fit in to ISO 9001? Process Maps, Process Mapping and Turtle Diagrams 39
P Does anyone have a API Q1 Documentation Package? Quality Management System (QMS) Manuals 1
N What is our product classification? (Does Unclassified classification still exists) Other US Medical Device Regulations 14
C Does a CE mark infer meeting all applicable standards? CE Marking (Conformité Européene) / CB Scheme 4
N Small Company - Internal audit process - Who does the audit? Internal Auditing 16
J Does anyone have an excel IATF 16949 Internal Audit checklist I could use? IATF 16949 - Automotive Quality Systems Standard 7
A Does AS9100 require traceability to operators performing the work? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 4
I Does anybody use Detection in medical device Design FMEA? ISO 14971 - Medical Device Risk Management 18
A EN ISO 14971:2019 does not include the Annex Zs ISO 14971 - Medical Device Risk Management 4
Watchcat Does "Similar Device" = "Predicate"? EU Medical Device Regulations 7
C Document Control Stamps - Does anyone still stamp their documents? Document Control Systems, Procedures, Forms and Templates 24
Y Does Solidworks (2D/3D drafting modules) need validation? Other Medical Device and Orthopedic Related Topics 5
M Definition Open Audit - What does an Open Audit mean? Definitions, Acronyms, Abbreviations and Interpretations Listed Alphabetically 3
I Does training have to be written? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 10
P What does UPH/m² mean? Quality Tools, Improvement and Analysis 3
L "IATF-Compliant" IATF 16949:2016 certification? What does this mean? IATF 16949 - Automotive Quality Systems Standard 13
D Why does Official Journal list superseded standards? EU Medical Device Regulations 6
B Record Management - Does the QMS need to control templates of records? Records and Data - Quality, Legal and Other Evidence 17
MDD_QNA QR Code Standard ISO/IEC 15417:2007 - Does anyone use it? Other Medical Device Related Standards 3
R Does any here use an internal auditing tool that works on different platforms? Internal Auditing 3
Sidney Vianna IAQG SCMH explains "positive risk"..........but does it? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 3
D Where does "as far as possible" stop? FMEA - EN 14971 ISO 14971 - Medical Device Risk Management 29

Similar threads

Top Bottom