Do you have procedures to control the design of your device?

Design controls are a set of quality practices and procedures that are designed to ensure that the device meets the user’s needs, the intended uses, and any other specified requirements.  Design controls can also improve and prevent future issues.

According to 21 CFR 820.30 Design control, all class III and II and specified class I devices should have procedures to control the design of the device.   There are 9 parts to design control, they include: design and development planning, design input, design output, design review, design verification, design validation, design transfer, design changes and design history file.  According to our Annual Report on the top cited 483 observations during FY 2022, lack of or inadequate procedures for design changes is listed in the top 10 cited observations.

A company was cited for:

ā€¦.. Procedures for design control have not been established.

Specifically, your firm’s SOP…, ā€œProduct Development Design Controlsā€, does not have adequate procedures to control the design of your devices.

a.         The design input section does not mention a mechanism for addressing incomplete, ambiguous, or conflicting requirement. The procedure also does not mention who the designated individuals are to sign off Design Input and Design Output documentation.

b.         The procedure does not identify the full provisions of the design review for the device according to FDA regulations. For example, it does not include provisions to ensure individual(s) who do not have direct responsibility for the design stage being reviewed.

c.         The procedure does not have any provisions for risk analysis.

d.         The design changes section does not mention validation or where appropriate verification, review, and, approval of design changes to be done before implementing the changes. Design Verification activities for the …. Battery Pack were not performed for the typical new battery runtime specification of … as defined in ā€œBattery Packā€ of the … Operating Instructions and … Operating Instructions.

For more information on Design Controls refer to FDA presentation Design Controls.  For more information on inspection procedures of design controls, refer to FDA Inspection Guide, Design Controls.

To view more observations pertaining to design controls, refer to the following GMP TrendsĀ® Issues: 1119, 1118, 1116 and 1110.

For more observations pertaining to devices, see our new Issue 1122 available today.  It also has observations pertaining to quality systems, manufacturing controls, and packaging and labeling.

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