Design Control 21 CFR 820.30 Process for Medical Devices

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US FDA 21 CFR 820.30 Design Control Requirements

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What's FDA Design Control?

• Design controls are defined as an interrelated
  set of practices and procedures incorporated into
  the design and development process. FDA design
  controls make a methodical assessment of the
  design an integral part of development. With
  design control, any scarcities in design input
  requirements or disagreement between the proposed
  designs and requirements are detected beforehand
  and corrected immediately in the development
  process. Design controls intend to increase the
  chances of transferring the design to product,
  without much difference, into a device suited for
  its intended use.
• Design control isn't a new conception, or indeed
  a new requirement, but a longstanding tradition
  in medical device manufacturing. Since 1990, the
  FDA has demanded medical device manufacturers
  misbehave with the criteria outlined in 21
  CFR820.30. These requirements aim to insure
  medical devices retailed in theU.S. match
  applicable standards and address the needs of
  cases and other users.

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The Benefits of Effective Design Control.

• The benefits of effective design control impact
  manufacturers as well as cases. Robust design
  control improves product safety, performance, and
  overall product quality. Process effectiveness
  shortens cycle times by providing quick access to
  crucial tasks and approvals. A guided-
  yet-flexible workflow improves the end- to- end
  process and provides control and consistent
  execution of tasks without duplicating effort.
• Effective design control also enables
  manufacturers to avoid potential compliance
  issues because all records, frompre-market design
  topost-market data collection and design change,
  arecross-referenced in one integrated system.
  Manufacturers can demonstrate that a controlled
  and documented process is in place and has been
  executed properly.
• Eventually, effective design control ensures all
  design, quality, and nonsupervisory data is
  examination ready. This factor eases the burden
  on manufacturers when preparing for checkups and
  helps reduce errors and inspection findings.

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What Are FDA Design Controls for Medical Devices?

• The design control process follows a set of
  practices and procedures that help medical
  product developers
• Manage quality.
• Manage quality.
• Ensure each product meets all requirements.
• Prevent potential issues or recalls in the
  future.
• FDA Design Controls
• Design controls for medical devices are regulated
  by the FDA under 21 CFR820.30. They must be
  enforced by manufacturers of class II or III
  medical devices( and some class I devices).

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