1. 820.30(b) Design a nd Deve lopme nt Planning
Each m anufac ture r shall establish and m aintain plans that de sc ribe or r efer ence the design and developm ent
ac tivities a nd de fine responsibility for implem entation.
The plans shall identif y a nd describe the interf ace s with diffe rent groups or a ctivities tha t pr ovide, or result
in, input to the de sign a nd deve lopme nt process.
The plans shall be revie wed as design and deve lopm ent evolves.
The plans shall be updated as design and developm ent evolves.
The plans shall be appr ove d a s design and development evolves.
2. 820.30(c ) Design Input
2.1. Ea ch ma nufa cturer shall establish pr ocedures to e nsure that the de sign requir eme nts relating to a
de vice are appr opriate and address the inte nded use of the device, inc luding the needs of the user
a nd pa tient.
2.2. Ea ch ma nufa cturer shall m aintain procedures to e nsure that the de sign requir eme nts relating to a
de vice are appr opriate and address the inte nded use of the device, inc luding the needs of the user
a nd pa tient.
2.3. The proc edures sha ll inc lude a m echanism for addre ssing incom plete r equirem ents.
2.4. The proc edures sha ll inc lude a m echanism for addre ssing am biguous requir eme nts.
2.5. The proc edures sha ll inc lude a m echanism for addre ssing conf licting requirem ents.
2.6. The de sign input r equire ments shall be doc um ented by a designate d individual(s).
2.7. The de sign input r equire ments shall be reviewed by a de signated individual(s).
2.8. The de sign input r equire ments shall be approved by a designa te d individual( s).
2.9. The appr ova l, including the date and signature of the individual(s) approving the requir eme nts,
shall be documented.
2.10. Que stions.
2.10.1. Sum ma riz e the ma nufa cture r's written procedure( s) f or identification and contr ol of
design input.
2.10.2. Fr om what sourc es are design inputs sought?
2.10.3. Do design input procedures cover the relevant aspects, such as: ( Ma rk all that apply and
list additiona l a spec ts.)
2.10.3.1. intended use
2.10.3.2. user /patient/clinic al
2.10.3.3. pe rform ance c haracter istics
2.10.3.4. saf ety
2.10.3.5. limits and tole rance s
2.10.3.6. risk analysis
2.10.3.7. toxicity and bioc om patibility
2.10.3.8. ele ctroma gne tic c om patibility ( EMC)
2.10.3.9. compatibility with ac cessor ie s/auxiliary device s
2.10.3.10. compatibility with the envir onm ent of intended use
2.10.3.11. hum an fac tors
2.10.3.12. physical/c hemica l cha racter istics
2.10.3.13. labe ling/pa ckaging
2.10.3.14. relia bility
2.10.3.15. statutory a nd re gulatory requirem ents
2.10.3.16. volunta ry standar ds
2.10.3.17. manufa ctur ing processes
2.10.3.18. sterility
2.10.3.19. MDRs/c omplaints/f ailure s a nd other historica l data
2.10.3.20. de sign histor y files (DHFs)
2.10.4. For the specific design cover ed, how were the design input re quirem ents identif ied?
2.10.5. For the specific design cover ed, how were the design input re quirem ents r evie wed f or
ade qua cy?
Com ply w ith FD A D esign C ontrol G uidance G M P R egula tion
1. Capture design and re la ted inform ation
1.1. Input electronic ally form atted data
1.2. Ref ere nce exter nal inform ation source s
1.3. Ref ere nce exter nal docum entation
2. Store de sign and related inf orm ation
2.1. Identify and ta g de sign infor ma tion a s unique “design elem ents”
2.2. O rganize de sign elem ents
2.2.1. O rganize by D esign C ontr ol G uidance Elem ent
2.2.2. O rganize by inter -re la tionships
2.3. Ensur e all de sign elem ents ar e available
2.3.1. Stor e design ele me nts by De sign Control G uidanc e Ele me nt
2.3.2. Stor e design ele me nts and the ir historical value s
3. Ma nage a ll use r needs
3.1. Identify the sourc e of the user need
3.2. Identify all user types (groups)
3.3. Identify the c ustom er (s)
3.4. Prof ile the expe cted pa tients
3.5. State the intende d use of the product (fam ily)
3.6. Capture the a cce pta nc e criteria for e ach user nee d
4. Ma nage de sign input requir em ents
4.1. Identify the sourc e of the r equireme nt
4.2. Identify the a ssociated user ne ed
4.3. Capture r equirem ent de sc ription a nd a ttribute s
4.4. Capture a cce pta nce cr iter ia
4.5. A ssign responsibility f or ea ch requir em ent
4.6. Ma nage incomplete re quire me nts
4.7. Ma nage am biguous requirem ents
4.8. Ma nage conflicting re quire me nts
4.9. A pprove all r equireme nts
5. Ma nage a cce ptanc e
5.1. Ensur e the acc eptance of eve ry user need
5.2. Ensur e the acc eptance of eve ry de sign input requirem ent
5.3. D ocum ent the re sults of e very use r need a cceptance te st
5.4. D ocum ent the re sults of e very design input require ments test
5.5. Ma ke acc eptance results available
6. Ma nage c hange
6.1. Ma intain history of design e le ment changes
6.1.1. Make com ple te c hange histor y available
6.1.2. Maintain history w ithin and a cross a ny orga niz ational proce dure
6.1.3. Maintain history w ithin and a cross a ny projec t m ilestone
6.1.4. Maintain history w ithin and a cross a ny D e sign Control Guidance Ele ments
6.2. Capture f requenc y and nature of e le me nt change s
6.2.1. Provide ra tionale for cha nge
6.2.2. D esc ribe dec isions m ade
6.2.3. Identif y approva l a uthority for the c hange
6.2.4. Capture da te , time , and signature of approving a uthority
6.3. Identify im pacted e lem ents due to a cha nge in another elem ent
6.3.1. Crea te backw ar d tr ace s to design elem ents w ithin and ac ross any organizational pr ocedure
6.3.2. Crea te backw ar d tr ace s to design elem ents w ithin and ac ross any projec t milestone
1.1. Identify impacted elements due to a change in another element
· Traceability Reports: consistency with driving design elements
· Impact Reports: other design elements affected
· Links to impacted design elements
1.1.1. Create backward traces to design elements within and across any organizational
procedure
· Traceability Reports: Procedure Attribute
1.1.2. Create backward traces to design elements within and across any project milestone
· Traceability Reports: Milestone Attribute
1.1.3. Create backward traces to design elements within and across Design Control
Guidance Elements
· Traceability Reports: Linked design elements
1.1.4. Create forward impacts to design elements within and across any organizational
procedure
· Impact Reports: Procedure Attribute
1.1.5. Create forward impacts to design elements within and across any project milestone
· Impact Reports: Milestone Attribute
1.1.6. Create forward impacts to design elements within and across Design Control
Guidance Elements
· Impact Reports: Linked design elements
1.2. Associate changed design elements with related elements
· Link Change Design Object with affected design element(s)
· Traceability Links and Reports from affected design element(s)
· Impact Links and Reports from affected design element(s)
1.2.1. Associate design element changes with decisions, rationale, and approval authority
information
· Change Decision Objects with following Attributes:
· Disposition Attribute
· Decision Attribute
· Rationale Attribute
· Owner Attribute
· Management Approval Attribute
1.2.2. Provide associations within and across any organizational procedure
· Change Design Object Traceability Link on Procedure Attribute
· Change Design Object Impacts Link on Procedure Attribute
1.2.3. Provide associations within and across any project milestone
· Change Design Object Traceability Link on Milestone Attribute
· Change Design Object Impacts Link on Milestone Attribute
1.2.4. Provide associations within and across Design Control Guidance Elements
· Change Design Object Traceability Link to traced design elements
· Change Design Object Impacts Link to linked design elements
1.3. Mange the change process
· Design Change Module
· Design Change Reports
· Object History
· Object History Reports
· Versions
· Baselines
1. 820.30(b) Design a nd Deve lopme nt Planning
Each m anufac ture r shall establish and m aintain plans that de sc ribe or r efer ence the design and developm ent
ac tivities a nd de fine responsibility for implem entation.
The plans shall identif y a nd describe the interf ace s with diffe rent groups or a ctivities tha t pr ovide, or result
in, input to the de sign a nd deve lopme nt process.
The plans shall be revie wed as design and deve lopm ent evolves.
The plans shall be updated as design and developm ent evolves.
The plans shall be appr ove d a s design and development evolves.
2. 820.30(c ) Design Input
2.1. Ea ch ma nufa cturer shall establish pr ocedures to e nsure that the de sign requir eme nts relating to a
de vice are appr opriate and address the inte nded use of the device, inc luding the needs of the user
a nd pa tient.
2.2. Ea ch ma nufa cturer shall m aintain procedures to e nsure that the de sign requir eme nts relating to a
de vice are appr opriate and address the inte nded use of the device, inc luding the needs of the user
a nd pa tient.
2.3. The proc edures sha ll inc lude a m echanism for addre ssing incom plete r equirem ents.
2.4. The proc edures sha ll inc lude a m echanism for addre ssing am biguous requir eme nts.
2.5. The proc edures sha ll inc lude a m echanism for addre ssing conf licting requirem ents.
2.6. The de sign input r equire ments shall be doc um ented by a designate d individual(s).
2.7. The de sign input r equire ments shall be reviewed by a de signated individual(s).
2.8. The de sign input r equire ments shall be approved by a designa te d individual( s).
2.9. The appr ova l, including the date and signature of the individual(s) approving the requir eme nts,
shall be documented.
2.10. Que stions.
2.10.1. Sum ma riz e the ma nufa cture r's written procedure( s) f or identification and contr ol of
design input.
2.10.2. Fr om what sourc es are design inputs sought?
2.10.3. Do design input procedures cover the relevant aspects, such as: ( Ma rk all that apply and
list additiona l a spec ts.)
2.10.3.1. intended use
2.10.3.2. user /patient/clinic al
2.10.3.3. pe rform ance c haracter istics
2.10.3.4. saf ety
2.10.3.5. limits and tole rance s
2.10.3.6. risk analysis
2.10.3.7. toxicity and bioc om patibility
2.10.3.8. ele ctroma gne tic c om patibility ( EMC)
2.10.3.9. compatibility with ac cessor ie s/auxiliary device s
2.10.3.10. compatibility with the envir onm ent of intended use
2.10.3.11. hum an fac tors
2.10.3.12. physical/c hemica l cha racter istics
2.10.3.13. labe ling/pa ckaging
2.10.3.14. relia bility
2.10.3.15. statutory a nd re gulatory requirem ents
2.10.3.16. volunta ry standar ds
2.10.3.17. manufa ctur ing processes
2.10.3.18. sterility
2.10.3.19. MDRs/c omplaints/f ailure s a nd other historica l data
2.10.3.20. de sign histor y files (DHFs)
2.10.4. For the specific design cover ed, how were the design input re quirem ents identif ied?
2.10.5. For the specific design cover ed, how were the design input re quirem ents r evie wed f or
ade qua cy?
Com ply w ith FD A D esign C ontrol G uidance G M P R egula tion
1. Capture design and re la ted inform ation
1.1. Input electronic ally form atted data
1.2. Ref ere nce exter nal inform ation source s
1.3. Ref ere nce exter nal docum entation
2. Store de sign and related inf orm ation
2.1. Identify and ta g de sign infor ma tion a s unique “design elem ents”
2.2. O rganize de sign elem ents
2.2.1. O rganize by D esign C ontr ol G uidance Elem ent
2.2.2. O rganize by inter -re la tionships
2.3. Ensur e all de sign elem ents ar e available
2.3.1. Stor e design ele me nts by De sign Control G uidanc e Ele me nt
2.3.2. Stor e design ele me nts and the ir historical value s
3. Ma nage a ll use r needs
3.1. Identify the sourc e of the user need
3.2. Identify all user types (groups)
3.3. Identify the c ustom er (s)
3.4. Prof ile the expe cted pa tients
3.5. State the intende d use of the product (fam ily)
3.6. Capture the a cce pta nc e criteria for e ach user nee d
4. Ma nage de sign input requir em ents
4.1. Identify the sourc e of the r equireme nt
4.2. Identify the a ssociated user ne ed
4.3. Capture r equirem ent de sc ription a nd a ttribute s
4.4. Capture a cce pta nce cr iter ia
4.5. A ssign responsibility f or ea ch requir em ent
4.6. Ma nage incomplete re quire me nts
4.7. Ma nage am biguous requirem ents
4.8. Ma nage conflicting re quire me nts
4.9. A pprove all r equireme nts
5. Ma nage a cce ptanc e
5.1. Ensur e the acc eptance of eve ry user need
5.2. Ensur e the acc eptance of eve ry de sign input requirem ent
5.3. D ocum ent the re sults of e very use r need a cceptance te st
5.4. D ocum ent the re sults of e very design input require ments test
5.5. Ma ke acc eptance results available
6. Ma nage c hange
6.1. Ma intain history of design e le ment changes
6.1.1. Make com ple te c hange histor y available
6.1.2. Maintain history w ithin and a cross a ny orga niz ational proce dure
6.1.3. Maintain history w ithin and a cross a ny projec t m ilestone
6.1.4. Maintain history w ithin and a cross a ny D e sign Control Guidance Ele ments
6.2. Capture f requenc y and nature of e le me nt change s
6.2.1. Provide ra tionale for cha nge
6.2.2. D esc ribe dec isions m ade
6.2.3. Identif y approva l a uthority for the c hange
6.2.4. Capture da te , time , and signature of approving a uthority
6.3. Identify im pacted e lem ents due to a cha nge in another elem ent
6.3.1. Crea te backw ar d tr ace s to design elem ents w ithin and ac ross any organizational pr ocedure
6.3.2. Crea te backw ar d tr ace s to design elem ents w ithin and ac ross any projec t milestone
1.1. Identify impacted elements due to a change in another element
· Traceability Reports: consistency with driving design elements
· Impact Reports: other design elements affected
· Links to impacted design elements
1.1.1. Create backward traces to design elements within and across any organizational
procedure
· Traceability Reports: Procedure Attribute
1.1.2. Create backward traces to design elements within and across any project milestone
· Traceability Reports: Milestone Attribute
1.1.3. Create backward traces to design elements within and across Design Control
Guidance Elements
· Traceability Reports: Linked design elements
1.1.4. Create forward impacts to design elements within and across any organizational
procedure
· Impact Reports: Procedure Attribute
1.1.5. Create forward impacts to design elements within and across any project milestone
· Impact Reports: Milestone Attribute
1.1.6. Create forward impacts to design elements within and across Design Control
Guidance Elements
· Impact Reports: Linked design elements
1.2. Associate changed design elements with related elements
· Link Change Design Object with affected design element(s)
· Traceability Links and Reports from affected design element(s)
· Impact Links and Reports from affected design element(s)
1.2.1. Associate design element changes with decisions, rationale, and approval authority
information
· Change Decision Objects with following Attributes:
· Disposition Attribute
· Decision Attribute
· Rationale Attribute
· Owner Attribute
· Management Approval Attribute
1.2.2. Provide associations within and across any organizational procedure
· Change Design Object Traceability Link on Procedure Attribute
· Change Design Object Impacts Link on Procedure Attribute
1.2.3. Provide associations within and across any project milestone
· Change Design Object Traceability Link on Milestone Attribute
· Change Design Object Impacts Link on Milestone Attribute
1.2.4. Provide associations within and across Design Control Guidance Elements
· Change Design Object Traceability Link to traced design elements
· Change Design Object Impacts Link to linked design elements
1.3. Mange the change process
· Design Change Module
· Design Change Reports
· Object History
· Object History Reports
· Versions
· Baselines
User Reqts Technical Reqts Test CasesDesign
Traceability is the key to conformance and compliance
•Initial user requirements will be decomposed to more detailed
requirements, then to design, tests, etc.
•Decomposition creates traceability relationships
•Relationships define your traceability model
•Your traceability model is the basis for your process
•Enforce your traceability model; improve your process