Center for Devices and Radiological Health

Final

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DESIGN CONTROL REPORT

AND GUIDANCE

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Revised May 1998

All Previous Editions Are Obsolete

Effective starting on June 1, 1998

Instructions:

  1. This document is to be used as an enforcement tool starting on June 1, 1998.
  2. This document is a Design Control (DC) Report form for reporting responses to selected items and discussing design control objectionable conditions and related discussions with management. This document contains guidance for the Investigator to use in evaluating compliance with the Design Control requirements of Section 820.30 of the Quality System Regulation. Selected items requiring documented responses appear in bold. The selected items should be addressed for every inspection that includes an evaluation of conformance with design controls. The DC Report is to be a stand-alone portion of the Establishment Inspection Report (EIR). Do not give a copy of the DC Report to the firm during or at the close of the inspection. A copy of the DC Report will be provided to the firm as a part of the EIR per FMD-145.
  3. The DC Report is to be completed by the Investigator based on the Investigator’s own evaluation of the firm’s Design Control System. This is to be accomplished via the Investigator’s own review and assessment of the firm’s procedures and their implementation. The Investigator should not merely ask the DC Guidance questions or requests and record the firm’s verbal responses. If a firm has completed a DC Report as part of an evaluation of their own internal systems, the Investigator may not accept that report in lieu of the Investigator’s own evaluation. Investigators shall not look at the firm’s completed DC report until after the Investigator has completed his/her own evaluation of the firm’s design controls. Do not collect a copy of the firm’s completed DC Report.
  4. If the firm has made no design changes and has no ongoing or planned design projects, the Investigator must still inspect the Design Change procedures and describe and document any deficiencies. If the firm has established additional Design Control procedures covering design activities other than design changes, the Investigator must also review those procedures in accordance with the DC Guidance and complete the appropriate sections of the DC Report.
  5. If design control deficiencies are identified, these deficiencies should be developed, listed on an FDA-483 in accordance with IOM procedures, and discussed in the DC Report under "Design Control Objectionable Conditions and Discussions with Management." Observations pertaining to design control deficiencies may be annotated just as observations describing other quality system deficiencies are annotated.
  6. This report will be a part of the manufacturer’s EIR and will be available to the public through the Freedom of Information Act (FOIA).
  7. Distribution:

Notes:

  1. Please identify device types traditionally manufactured by the firm if no specific project is available for review. This information should be recorded under 820.30(a), General, Question #1, of the report.

2. A negative response to a DC question is not necessarily a citable deficiency. For example: Not all of the potential inputs listed in question 2 of "820.30(c) Design input" are necessary for all design projects.

  1. In addition to his/her signature, the Investigator must legibly print or type his/her name.
  2. There are four PAC Codes available for reporting Design Control inspections as follows:

82830D = Domestic Design Control Inspections

83830D = Domestic Pre-Approval Design Control Inspections

82R915 = Foreign Design Control Inspections

83R915 = Foreign Pre-Approval Design Control Inspections

 

 

Design Control Report

Name of Establishment:

CFN or FEI Number:

Date(s) of Inspection:

Type of Inspection: PMA [ ] Q.S. Reg. [ ] 510(k) [ ] Other [ ]

820.30(a) General

Regulatory Requirements

  1. Each manufacturer of any class III or class II device, and the class I devices listed in paragraph (a)(2) of this section, shall establish and maintain procedures to control the design of the device in order to ensure that specified design requirements are met.
  2. The following class I devices are subject to design controls:
  1. Devices automated with computer software; and
  2. The devices listed in the chart below.

Section

Device

868.6810

878.4460

880.6760

892.5650

892.5740

 Catheter, Tracheobronchial, Suction

Glove, Surgeon’s

Restraint, Protective

System, Applicator, Radionuclide, Manual

Source, Radionuclide, Teletherapy

Instructions

1. Select a device that was subject to design controls. Describe the device. What is it used for? Who will use it (e.g., doctors, nurses, patients, etc.)? Indicate whether this was a design project for an original design or a modification of an existing design with a Y for Yes or an N for No.

Description of Device

  

 

 

What is the device used for?

  

 

Who will use the device?

  

 

 

Y or N

  
  Original design
  Modification of existing design

2. For the device selected, identify at what stage in the design and development effort design controls were applied. If the design and development effort has not been completed, identify the current status of the design and development effort. If the design and development effort was initiated prior to June 1, 1998, at what stage was the design process on June 1, 1998?

Activity or Date

Stage of Design & Development

When design controls were applied  
Currently  
As of June 1, 1998  

820.30(b) Design and development planning

Regulatory Requirements

Each manufacturer shall establish and maintain plans that describe or reference the design and development activities and define responsibility for implementation. The plans shall identify and describe interfaces with different groups or activities that provide, or result in, input to the design and development process. The plans shall be reviewed, updated, and approved as design and development evolves.

Instructions

  1. Determine if the design and development plan describes or references and assigns responsibility for the implementation of each of the activities listed on the chart below. (Y=Yes, N=No)
  2. Discuss with the manufacturer (and list on the chart below) any alternative terminology used by the manufacturer in the design process.

Responsibility

Assigned? Y or N

Design Activity

Alternative Terminology

  Risk analysis  
  Design input  
  Design output  
  Design review  
  Design verification  
  Design validation  
  Design transfer  
  Design changes  
  Interfaces  
  1. Determine whether the plan has been reviewed, updated, and approved as design and development evolves.

820.30(c) Design input

Regulatory Requirements

Each manufacturer shall establish and maintain procedures to ensure that the design requirements relating to a device are appropriate and address the intended use of the device, including the needs of the user and patient. The procedures shall include a mechanism for addressing incomplete, ambiguous, or conflicting requirements. The design input requirements shall be documented and shall be reviewed and approved by a designated individual(s). The approval, including the date and signature of the individual(s) approving the requirements, shall be documented.

Instructions

  1. Review the manufacturer’s written procedure(s) for identification and control of design input.
  2. Does the design input procedure(s) cover the relevant aspects listed below? (Y=Yes, N=No, NA=Not Applicable)

Y, N or NA

Potential Design Input

  Intended use
  User/patient/clinical
  Performance characteristics
  Safety
  Limits and tolerances
  Risk analysis
  Toxicity and biocompatibility
  Electromagnetic compatibility (EMC)
  Compatibility with accessories/auxiliary devices
  Compatibility with the environment of intended use
  Human factors
  Physical/chemical characteristics
  Labeling/packaging
  Reliability
  Statutory and regulatory requirements
  Voluntary standards
  Manufacturing processes
  Sterility
  MDRs/complaints/failures and other historical data
  Design history files (DHFs)
  Other (describe):

3. Review the process for resolving incomplete, ambiguous, or conflicting requirements. For the design reviewed, determine whether any incomplete, ambiguous, or conflicting requirements were not resolved per the manufacturer’s procedures.

4. Review how the design input addresses the user interface: the hardware (and software, if applicable) and features that define the interactions between users and the device. Examples are exploratory studies (e.g., interviews), usability studies (e.g., user evaluation, task analysis, risk analysis, or workload analysis), or any combination thereof.

5. Confirm that design input is reviewed, approved and documented.

820.30(d) Design output

Regulatory Requirements

Each manufacturer shall establish and maintain procedures for defining and documenting design output in terms that allow an adequate evaluation of conformance to design input requirements. Design output procedures shall contain or make reference to acceptance criteria and shall ensure that those design outputs that are essential for the proper functioning of the device are identified. Design output shall be documented, reviewed, and approved before release. The approval, including the date and signature of the individual(s) approving the output, shall be documented.

Instructions

  1. Review the manufacturer’s design output procedure(s).
  2. Confirm how design outputs are expressed in terms that allow comparison to design inputs.
  3. Review how the characteristics essential to the proper functioning of the device are identified.

4. Confirm that design output is reviewed, approved and documented.

820.30(e) Design review

Regulatory Requirements

Each manufacturer shall establish and maintain procedures to ensure that formal documented reviews of the design results are planned and conducted at appropriate stages of the device’s design development. The procedures shall ensure that participants at each design review include representatives of all functions concerned with the design stage being reviewed and an individual(s) who does not have direct responsibility for the design stage being reviewed, as well as any specialists needed. The results of a design review, including identification of the design, the date, and the individual(s) performing the review, shall be documented in the design history file (the DHF).

Instructions

  1. Review the manufacturer’s procedure(s) for defining and controlling formal design reviews. Confirm the design review procedure(s) assures that formal design reviews are comprehensive and systematic.
  2. Confirm the manufacturer has identified appropriate stages of design and development for formal design reviews.
  3. Confirm the documentation exists to demonstrate that the manufacturer has conducted formal design reviews at identified stages.
  4. Review the documentation from at least one formal design review and verify that the appropriate organizational functions participated, including at least one individual not having direct responsibility for the design stage being reviewed. Confirm that problems or action items identified during a formal design review were addressed.

820.30(f) Design verification

Regulatory Requirements

Each manufacturer shall establish and maintain procedures for verifying the device design. Design verification shall confirm that the design output meets the design input requirements. The results of the design verification, including identification of the design, method(s), the date, and the individual(s) performing the verification, shall be documented in the DHF.

Instructions

  1. Review the manufacturer’s procedure(s) for design verification. (Verification may occur at one point or multiple points.)
  2. Review significant verification methods and activities used to confirm the input requirements have been fulfilled by the design output. If output does not meet input, confirm the manufacturer resolved the discrepancy.

820.30(g) Design validation

Regulatory Requirements

Each manufacturer shall establish and maintain procedures for validating the device design. Design validation shall be performed under defined operating conditions on initial production units, lots, or batches, or their equivalents. Design validation shall ensure that devices conform to defined user needs and intended uses and shall include testing of production units under actual or simulated use conditions. Design validation shall include software validation and risk analysis, where appropriate. The results of the design validation, including identification of the design, method(s), the date, and the individual(s) performing the validation, shall be documented in the DHF.

Instructions

  1. Review the manufacturer’s procedure(s) for design validation. For the design project chosen, confirm the design validation was accomplished in accordance with established procedures that include defined operating conditions, user needs, and intended uses.
  2. If design validation was not accomplished using production device(s), how was equivalency demonstrated?
     

     

     

     

     

  3. Review the evaluations (clinical or other activities) performed to assist in validating that the device design meets defined user needs and intended use(s). Design validation activities may include, but are not limited to the activities listed below. Identify the Design Validation activity(ies) used. (Y=Yes, Used; N=No, Not Used)
Y or N

Design Validation Activity

Clinical studies approved via Institutional Review Boards (IRBs) and Investigational Device Exemptions (IDEs), or IRB approvals alone for non-significant (risk) devices.
Clinical evaluations in clinical or non-clinical settings
Simulated use (conditions)
510(k) historical database search
Literature search
Review of labels and labeling, packaging, and other historical product information
Other (describe):

 

4. If the chosen device contains software, review the software validation.

  1. Identify any risk analysis tools and/or techniques such as Failure Mode Effects Analysis (FMEA), Failure Mode Effects and Criticality Analysis (FMECA), Fault Tree Analysis (FTA), etc. and any Risk Analysis Standards used. (Y=Yes, Used N=No, Not Used)

Y or N

Risk Analysis Tool/Technique

Standard used

(if applicable)

  Failure Mode Effects Analysis (FMEA)  
  Failure Mode Effects and Criticality Analysis (FMECA)  
  Fault Tree Analysis (FTA)  
  In-House  
  Other (describe):  

6. Confirm that design validation data show the approved design meets the predetermined user needs and intended use(s) and that the completed design validation did not leave any unresolved discrepancies.

820.30(h) Design transfer

Regulatory Requirements

Each manufacturer shall establish and maintain procedures to ensure that the device design is correctly translated into production specifications.

Instructions

  1. Review the design transfer procedure. Confirm that procedures for design transfer were followed.
  2. Compare the significant elements of the device master record with the finished design outputs to confirm that the design was correctly transferred.

820.30(i) Design changes

Regulatory Requirements

Each manufacturer shall establish and maintain procedures for the identification, documentation, validation or where appropriate verification, review, and approval of design changes before their implementation.

Instructions

Note: 820.30(i) relates to Product Design Changes. Changes to existing Production Processes should also be evaluated under 820.70(b).

  1. Review the design change procedure(s) for both original designs and changes to existing designs. Reminder: At a minimum, a Change Control Procedure is required for all firms.
  2. Confirm the design changes were made according to change control procedures.
  3. Confirm the design change procedure(s) assures that design changes are validated or where appropriate verified.
  4. For design changes that were verified but not validated, confirm that the manufacturer justified that validation was unnecessary, as explained in Section 820.1(a)(3).

5. Confirm design changes are reviewed, approved and documented.

  1. Confirm design changes were communicated to appropriate individuals involved in the design process.

820.30(j) Design history file

Regulatory Requirements

Each manufacturer shall establish and maintain a DHF for each type of device. The DHF shall contain or reference the records necessary to demonstrate that the design was developed in accordance with the approved design plan and the requirements of this part.

Instructions

  1. Confirm the design history file contains the elements to support that the design was developed in accordance with the design plan and procedures (e.g., design plan, design input, design output, design review, design verification, design validation, design transfer, design changes).
  2. If more than one device shares a common design history file, confirm the firm can identify each device within the family or group having common design characteristics.

Design Control Objectionable Conditions and Discussions with Management:
 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Name(s)

  

Title(s)

  

 

Signature(s)  
Date