Product
Documentation
Chapter 5
Title 21 of the Code of
Federal Regulations
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Volume 1: Parts 1-99 (FDA, General)
Volume 2: Parts 100-169 (FDA, Food for Human Consumption)
Volume 3: Parts 170-199 (FDA, Food for Human Consumption)
Volume 4: Parts 200-299 (FDA, Drugs: General)
Volume 5: Parts 300-499 (FDA, Drugs for Human Use)
Volume 6: Parts 500-599 (FDA, Animal Drugs, Feeds and Related
Products)
 Volume 7: Parts 600-799 (FDA, Biologics; Cosmetics)
 Volume 8: Parts 800-1299 (FDA, Medical Devices)
 Volume 9: Parts 1300-End (DEA and Office of National Drug
Control Policy)
21CFR part 820 requires:
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Business proposal
Product specification
Design specification
Software Quality Assurance Plan*
Software Requirements Specification*
Software Design Description*
* = if /where applicable
Primary types of records
 Design History File
(DHF)
 Device Master Record
(DMR)
 Device History Record
(DHR)
 Technical
Documentation File
(TDF)
Business Proposal
Project
Overview
Core Project
Team
Recommendation
Market Need
and Potential
Business
Proposal
Product
Proposal
Supporting
Documentation
Economic
Analysis
Strategic Fit
Risk Analysis
and Research Plan
Project Overview, Objectives,
Major Milestones, and Schedule
 Statement of overall project objectives
and major milestones
 Objectives clearly define project scope
and provide specific direction
 Schedule anticipates key decision
points and completion of primary
deliverables
 Events contingent upon achievements
of estimated dates should be stated
Example Timeline (Gantt)
Market Need/ Potential
 Defines customer and
clinical need for
product or service
 Identifies potential
territories to be served
 Examine market size
and trends
 Compare product
with competitors, …
Product Proposal
 Proposes the product idea
that fulfills the market need
 Differentiates product
features
 Explains user and/or
clinical value
 Several alternatives
product ideas should be
evaluated against ‘base
case’ idea
Strategic Fit
 Discusses how the proposed product conforms
with (or departs from) stated technology with
respect to:
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Product
Market
Clinical setting
Technology
Design
Manufacturing
Service
Where do the pieces fit?
Risk Analysis and
Research Plan
 Assessment of risks and unknowns
 Estimate of resources needed to reduce risks
to a level with a reasonably high level of
confidence
 Risk categories:
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Technical
Market
Financial
Regulatory
Available resources
Schedule
Economic Analysis
 Rough estimate of
costs and personnel
required to specify,
design, develop, and
launch each product
variant into the
market place
Core Project Team
 Formation of core project team to
perform research to reduce risks,
develop user specification, and prepare
project plan
 Outline requisite skills of proposed team
members
 Estimate approximate time required of
each participant
 Estimate incremental expenses
NCIIA Example follows:
Proposal
Requirements
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Project and feature descriptions
Project’s market potential
Social and environmental impact
Team members, skills, roles, resumes
All advisors
Work plan and timeline
Necessary equipment and resources
Budget in tabular format
Proposal Evaluation
– Project Aspect
 Technical feasibility.
 Technology that is appropriate, achievable,
and commercially sustainable.
 A plan and budget are reasonable and
achievable.
 Likelihood of development of a licensable or
marketable product or service.
 Demonstrated knowledge of market and
evidence of consumer interest.
Proposal Evaluation
-Team Aspect
 Appropriate student and advisor skills
 Team membership:
• Balance of business, technical, and other
specialists.
• External mentors.
• Diversity reflecting the institution’s population.
 Team (faculty, students, mentors, and
institution) commitment.
 Strong faculty recommendations.
Product Specification
 First step in
transforming product
ideas into approved
product development
efforts
 Subject to revision
level control
 Joint ownership
among all concerned
departments
Product specification
helps turn this into reality
Design Specification
 Derived from product specification
 Requirements are reduced to specific
design requirements
 Addresses each subsystem
 Each performance specification should
be listed with nominal worst case
requirements
Software Quality
Assurance Plan (SQAP)
 Assures that procedures, tools
and techniques used during
software development and
modification are adequate to
provide desired level of
confidence in final product
 Assures that software does not
reduce reliability of device
 Detailed listing of requirements
Software Requirements
Specification (SRS)
 Specification for a particular
software product or
programs that perform
certain functions
 Correctly defines software
requirements
 Each software requirement
is a statement of some
essential capability of the
software to be developed
Software Design
Description (SDD)
 Specifies necessary information content
and recommended organization for a
software design description
 Detailed blueprint for implementation
activity
 Each requirement must be traceable to
one or more design entities
Records Mandated:
Design History File (DHF)
 Compilation of records which describes the
design history of a finished device
 Contains or references the records necessary
to prove that the design was developed in
accordance with approved design plans
 Contains ‘institutional’ memory of previous
design activities
 Contains verification and validation protocols
Device Master Record
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Design specifications
Production specifications
QA procedures
Packaging/labeling specifications
Install/maintenance/service methods
Device History Record
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Date(s) of manufacture
Quantities manufactured
Quantities released
Acceptance records (DMR proof)
ID & labeling information
Device ID/control numbers
MDRs
Technical Documentation
File (TDF)
 Contains relevant design data which
demonstrates that essential safety
requirements are satisfied
 File must be kept for 10 years after production
stops in case of liability proceedings
 Allows assessment of the conformity of the
product with requirements of the Medical
Device Directives