Design Control Guidance For Medical Device Manufacturers: Guidance for Industry

Key Topics

Terms and concepts identified from this document

Scope & Applicability

Product Classes

4

Medical Device

FDA intends to assess device cybersecurity based on a number of factors; demonstrate or maintain its safety and effectiveness; ensuring cybersecurity has become essential to FDA’s ability to protect the public health; Cyber-resiliency capabilities for medical devices

Class III Device

Generally recommended for Enhanced Documentation; Regulatory classification mentioned for implantable sensors and HPV tests; Mentioned in the context of an in vitro nucleic acid test for CMV DNA.

Class II Device

Devices subject to section 522 postmarket surveillance orders; devices subject to postmarket surveillance orders

Class I Device

Low risk medical devices

Stakeholders

9

Manufacturer

Entity responsible for submitting NDINs

Contractor

Contract acceptor for transportation of APIs

independent reviewer

Individual without direct responsibility for the design stage under review

Marketing Staff

Personnel who identify customer needs and create concept documents.

Product Developer

Individuals responsible for translating user needs into engineering requirements.

independent auditors

External resources that may be involved in the design process.

contract manufacturers

Entities eligible to request AMT designation

Management with executive responsibility

Senior management responsible for quality policy

senior management

involved in considering applicant concerns if present at the meeting

Regulatory Context

Regulatory Activities

3

Practice Audits

Method used by FDA to assist in understanding regulations

Recall

Tattoo ink firms conducted voluntary ink recalls due to microbial contamination

clinical trials

monitoring growth and pubertal development in clinical trials

Document Types

10

Consent Form

IEC IRB Consent Form List in eCTD

Change Control Records

Documentation of changes made to the design.

Design Output Documents

The results of a design effort at each design phase.

Design Input Documents

Records of physical and performance requirements of a device.

Software Source Code

Critical design information mentioned in a case study regarding maintenance and validation.

Laboratory Notebooks

Records maintained by engineers that may form part of the design history.

Design Plan

Approved plan that the design development must follow.

master list

Index of documents defining the product or process

change order

Document issued to implement a specific revision to a document

change request

Document used to identify a design problem for correction

Attributes

7

design defects

Potential outcome of scheduling pressures and poor planning.

Environmental Conditions

Simulation of temperature, humidity, shock, and vibration during validation

User needs

Basis for design validation

Interface Requirements

Characteristics critical to compatibility with external systems and users.

Performance Requirements

Specifications regarding speed, strength, accuracy, and limits of operation.

Functional Requirements

Specifications of what the device does and its operational capabilities.

Intended Use

Evidence of a new intended use based on communications

Technical Details

Testing Methods

10

Program Evaluation and Review Technique

Project management tool (PERT) used for planning complex projects.

Clinical Trials

Method used to establish clinical association.; Method for generating new evidence for clinical validation

Package integrity tests

Verification of packaging

Worst case analysis

Verification that components are derated properly

Thermal analysis

Used for characterization of physical forms.

Bioburden testing

Testing performed on final finished product

Biocompatibility testing

Should be performed on the sterilized finished product simulating clinical use.

Failure modes and effects analysis

Analysis to identify potential failure modes of a DHT

Fault tree analysis

Verification method for process or design

vibration testing

Specialized assessment to verify performance under stress

Processes

10

Verification

Activity to ensure cybersecurity changes do not impact safety

Design Control

Requirement for class II and class III devices

Risk Analysis

Identification of potential sources of error for a device

Software Validation

Ensures inputs and outputs are appropriate for assay requirements

Change Control

Procedures used to manage system updates and subsequent validation.

Design Review

Documented, comprehensive, systematic examination of a design; Overlaps with verification and validation

Validation

Activity to ensure cybersecurity changes do not impact effectiveness

Design Verification

Process to confirm that design output meets design input requirements.

Design Validation

Process to ensure devices conform to defined user needs and intended uses.

Design Transfer

Design successfully transferred into production

Clinical Concepts

2

Research Study

Context for the sample consent form

Patient Needs

enhanced understanding of the degree of conformance of a design to user and patient needs

Identified Hazards

Hazards

5

development risk

Inherent risks in the design process that planning aims to mitigate.

Safety hazards

Risks arising from unverified design changes late in the cycle

Electrostatic Discharge

A type of EM disturbance that can degrade device performance

design errors

Problems intended to be detected early through formal reviews

Electromagnetic Compatibility

A performance and safety concern to be addressed in design inputs.

Standards & References

External Standards

1

Industry Standards

citations should be reviewed for completeness and relevance

Specifications

8

Design Input

Design control begins with development and approval of design inputs; Requirements that design output must meet

production specifications

Documents and articles used to manufacture production devices

Intended Use

validate computer software used as part of production or the quality system for its intended use

User Needs

Basis against which design validation is performed

Design Output

Result of the design process to be verified

tolerance specifications

Established for components to meet overall dimensional specifications

Acceptance Criteria

limits for solid state form and particle size; Tightening acceptance criteria; Numerical limits or ranges for tests

Pass/Fail Criteria

Description of any Pass/Fail criteria specific to the device beyond the requirements specified in the standard

Related CFR Sections (1)

21CFR820.3§ 820.3 Definitions.
The definitions in ISO 13485 and in Clause 3 of ISO 9000 (incorporated by reference, see § 820.7 ) apply to this part, except as specified in paragraph (b) of this section, and do not affect the meaning of similar terms defined in this title.Read full regulation →

Enforcement Impact

Deficiencies cited in Warning Letters referencing the same regulations

Adulterated under section 501(f)(1)(B)

21

Misbranded under section 502(o)

19

Failure to adequately develop, maintain, and implement written MDR procedures

10

Failure to establish and maintain procedures to control the design of the device

10

Failure to establish and maintain procedures for implementing corrective and preventive action

10

Failure to adequately establish and maintain procedures for receiving, reviewing, and evaluating complaints

8

Failure to establish and maintain procedures for implementing corrective and preventive actions

8

Failure to establish and maintain procedures for receiving, reviewing, and evaluating complaints

8

Unapproved Device Violations

8

Failure to develop, maintain, and implement written Medical Device Reporting (MDR) procedures