Documents, Change Control and 

Records

Joseph Tartal

Deputy Director

Division of Industry and Consumer Education

Office of Communication and Education

Center for Devices and Radiological Health

U.S. Food and Drug Administration
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Learning Objectives

1. Identify key definitions related to documents and records

2. Describe key categories and how they inter-relate

3. Describe requirements and intent for Document Controls, 

General Records, Device Master Records, Device History 

Records, and Quality System Records

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Definitions

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Definitions (21 CFR 820.3)

• Establish

define, document (in writing or electronically), and implement

[21 CFR 820.3(k)] 

• Design history file (DHF)

compilation of records which describes design history of a finished device 

[21 CFR 820.3(e)]

CFR = Code of Federal Regulations

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Definitions (21 CFR 820.3)

• Device master record (DMR)

compilation of records containing procedures and specifications for a 

finished device

[21 CFR 820.3(j)]

• Device history record (DHR)

compilation of records containing production history of a finished device

[21 CFR 820.3(i)]
Overview of

Documents and Records

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Document and Record: Overview

Design History File 820.30(j)

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Device Master Record 

820.181

Device History Record 

820.184

Quality System Record 

820.186 

Document 

Controls 820.40

General Requirements 820.180
Design History File 820.30(j)

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Device Master Record 

820.181

Device History Record 

820.184

Quality System Record 

820.186 

Document 

Controls 820.40

General Requirements 820.180
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Document Controls

• Establish and maintain procedures to control all 

documents required by 21 CFR Part 820

• Procedures shall provide for:

1. Document Approval

2. Document Distribution

3. Document Changes
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1. Document Approval

• Designate individual(s) to:

– review documents for adequacy

– approve documents prior to issuance

• Document approval must include:

– date and signature of approving individual(s)
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2. Document Distribution

• Required documents shall be available

– at all locations where designated, used, or otherwise 

necessary

• Obsolete documents:

– remove promptly or

– prevent unintended use 
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3. Document Changes

• Changes to documents

– require review/approval

– by individual(s) from same function or organization that 

performed original approval

– unless specifically noted otherwise

• Changes must be communicated

– to appropriate personnel in a timely manner
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Preamble: Review of Changes

Intent

• Ensure that original document approver has 

opportunity to review any changes

• Document approvers typically have best insight on 

impact of changes
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Preamble: Review of Changes

Flexibility

• Permits manufacturer to designate others (not 

original document approver) to review and 

approve changes
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Preamble: Communicating Changes

to Personnel

“FDA has had many experiences where manufacturers 

made corrections to documents, but the changes were 

not communicated in a timely manner to the 

personnel utilizing the documents. The result of these 

untimely communications was the production of 

defective devices.” 

Preamble, Comment 96
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3. Document Changes

Include in change records: 

1. Description of change 

2. Identification of affected documents

3. Signature of approving individual(s) 

4. Approval date 

5. Date change becomes effective
Design History File 820.30(j)

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Device Master Record 

820.181

Device History Record 

820.184

Quality System Record 

820.186 

Document 

Controls 820.40

General Requirements 820.180
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Records – General Requirements

• Maintain all records required by Part 820:

– at manufacturing site or

– at location reasonably accessible to manufacturer 

and FDA

• Make required records readily available for 

review and copy 
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Preamble: “readily available” records

“FDA expects that such records will be made available 

during the course of an inspection. If the foreign 

manufacturer maintains records at remote locations, such 

records would be expected to be produced by the next 

working day or two, at the latest...”

Preamble, Comment 180
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Records – General Requirements

• Shall be legible

• Stored in a way that minimizes deterioration 

and prevents loss

• Records stored in an automated data processing 

system shall be backed up
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Records - Confidentiality

• During an inspection manufacturers may mark 

records as “confidential”

– to assist FDA in determining whether information 

may be disclosed under Freedom of Information Act
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Records: Exceptions

Manufacturers are not required to make these 

record types available for review and copy by FDA:

• management review reports and results

• quality audit reports

• evaluations of suppliers, contractors and consultants 
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Records: Exceptions

• However, during FDA inspections manufacturers 

must make procedures available for review for: 

• management reviews

• quality audits 

• evaluating suppliers, contractors and consultants
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Record Retention Period

Retain all records required by Part 820 for:

• expected life of device, or

• at least 2 years from date of release for commercial 

distribution
Design History File 820.30(j)

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Device Master Record 

820.181

Device History Record 

820.184

Quality System Record 

820.186 

Document 

Controls 820.40

General Requirements 820.180
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Device Master Record 

• Maintain a Device Master Record (DMR)

• Prepare and approve DMR in accordance with 

21 CFR 820.40, “Document Controls”
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DMR: What’s Included

1. Device specifications

2. Production and process specifications

3. Quality assurance procedures and specifications

4. Packaging and labeling specifications

5. Installation, maintenance and servicing procedures
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1. Device Specifications 

• Bill of Materials

• Drawings and 

schematics 

• List of Ingredients

• Component 

Specifications

• Material Composition

• Formulations

• Assemblies 

• Software specifications 
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2. Production and Process Specifications 

• Production environment 

specifications

• Cleaning procedures

• Equipment 

specifications

• Calibration procedures

• Process flow charts

• Set-up procedures

• Production methods

• Production procedures
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3. Quality Assurance 

• Acceptance criteria

• Testing and 

measurement equipment

• Inspection/test 

procedures

• Inspection/test forms

• Instrument charts

• Reporting forms

• Process control 

charts
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4. Packaging and Labeling 

• Packaging and labeling 

specifications 

• Package/Label drawings

• Instructions for Use 

• Service manuals

• Packaging/labeling review 

and control

• Packing procedures

• Shipping procedures

• Customer feedback forms
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5. Installation, Maintenance, and

Servicing 

• Installation procedures

• Service procedures

• Tools, testers and instruments

– for installation and servicing

• Forms for installation and servicing

– including regulatory forms as necessary
Design History File 820.30(j)

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Device Master Record 

820.181

Device History Record 

820.184

Quality System Record 

820.186 

Document 

Controls 820.40

General Requirements 820.180
Device History Record 

• Maintain device history record (DHR)

– to demonstrate that device is manufactured in 

accordance with the Device Master Record and 

Part 820

• Establish and maintain procedures for DHR

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Device History Record 

Shall include:

1. Dates of manufacture

2. Quantity manufactured

3. Quantity released for distribution

4. Acceptance records that demonstrate device is 

manufactured in accordance with Device Master Record

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Device Labeling and the DHR

Document in the DHR:

• Release of labels and date/signature of person 

examining the labeling 

• Label/labeling used for each production unit, lot 

or batch

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Preamble: Automated Readers for 

Labeling Inspections

“several recalls on labeling have been attributed to 

automated readers not catching errors. The requirement does 

not preclude manufacturers from using automated readers 

where that process is followed by human oversight. A 

“designated individual” must examine, at a minimum, a 

representative sampling of all labels that have been checked 

by the automated readers.”

Preamble, Comments 169

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Design History File 820.30(j)

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Device Master Record 

820.181

Device History Record 

820.184

Quality System Record 

820.186 

Document 

Controls 820.40

General Requirements 820.180
Quality System Record 

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• Maintain Quality System Records (QSR)

• Prepare and approve per 21 CFR 820.40

• Include/refer to location of: 

– Procedures and documentation of activities required by Part 

820 that are not specific to a particular type of device

– Records required by 21 CFR 820 Subpart B 
Quality System Record: Examples

• Training Procedures and Qualification Records

• Internal Audit Procedures and Records

• Management Review Procedures and Records

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Your Call to Action

1. Meet your document and record requirements. 

2. Take time to learn about documents, document 

controls and how to write good documents. 

3. Write useful and effective documents that provide 

direction and evidence of compliance and quality.

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QS Regulation and Guidance

• Quality System Regulation and Preamble

www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=820&showFR=1

www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/PostmarketRequirements/QualitySystemsRegulati

ons/ucm230127.htm

• Inspection Guide – Pages 8, 15, 21, 22 and 23

https://www.fda.gov/ICECI/Inspections/InspectionGuides/ucm074899.htm

• Guide to Inspections of Quality Systems [Quality System 

Inspection Technique (QSIT)]

www.fda.gov/iceci/inspections/inspectionguides/ucm074883.htm

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Industry Education:

Resources for You

1. CDRH Learn: Multi-Media Industry Education

 over 125 modules

 videos, audio recordings, power point presentations, software-based “how to” modules

 mobile-friendly: access CDRH Learn on your portable devices

www.fda.gov/Training/CDRHLearn

2. Device Advice: Text-Based Education

 comprehensive regulatory information on premarket and postmarket topics

www.fda.gov/MedicalDevices/DeviceAdvice

3. Division of Industry and Consumer Education (DICE)

 Contact DICE if you have a question

 Email: DICE@fda.hhs.gov

 Phone: 1(800) 638-2041 or (301) 796-7100 (Hours: 9 am-12:30 pm; 1 pm-4:30pm EST)

 Web: www.fda.gov/DICE 44
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