FDA 21 CFR Part 820 – Quality System Regulation (QSR) for Medical Devices

The FDA provides a set of Quality System requirements for FDA-regulated products (foods, drugs, devices, etc.) to ensure the safety and efficacy of the product when it reaches consumers. These requirements are also known as current Good Manufacturing Practices (cGMP) and are published in the FDA’s Code of Federal Regulation (CFR) Title 21 (relating to Food and Drug) Part 820 (Quality System Regulation).

This article is meant to provide some brief summary regarding the Design Controls, Document Controls, and Records (Design History File, Device Master Record, Device History, Quality System Record, and Complaint Files) within Part 820. Details summary for the above sections can be found at the end of the Table of Contents.

TABLE OF CONTENTS

Design Controls (Subpart C 820.30)

TL; DR: The Design Controls procedure is similar to the Design and Development processes (Section 7.3) of the ISO 13485:2016. It includes procedures for planning, input, output, review, verification, validation, and transfer of design for medical devices.

  • Design controls is required for the following manufacturers:
    • Class III
    • Class II
    • Class I devices that are automated with computer software and devices listed below:
      • Tracheobronchial Suction Catheter
      • Surgeon’s Glove
      • Protective Restraint
      • Radionuclide Manual Applicator System
      • Radionuclide Teletherapy Source
  • Design and development (D&D) planning
    •  The plan includes:
      • Description or reference to the D&D activities
      • Responsibility for implementation
      • Sources of input to D&D process
    • The plan must be reviewed, updated, and approved as D&D evolves.
  • Design input procedures
    • Design input includes:
      • Appropriate design requirements that address the intended use of the device (including needs of user and patient)
      • Mechanism of addressing incomplete, ambiguous, conflicting requirements.
    • Design input must be documented, review, and approved (signed and dated) by authorized individual(s).
  • Design output procedures
    • Design output must be put in terms that allow evaluation of conformance against design input requirements, including:
      • Identification of design outputs that are essential to the proper functioning of the device
      • Acceptance criteria
    • Design output must be documented, review, and approved (signed and dated) by authorized individual(s).
  • Design review procedures
    • Formal design review must be planned, conducted at appropriate stages of developments, and documented. Formal review process must include:
      • Any necessary specialists
      • Representatives of relevant functions
      • An individual(s) who is not directly responsible for the design stage being reviewed.
    • The result of the review must be documented in the DHF, including the identification of the design, date, and individual(s) performing the review
  • Design verification procedures must confirm that design output meets design input requirements.
    • The result of design verification must be documented in the DHF, including the identification of the design, method(s), date, and individual(s) performing the verification.
  • Design validation procedures must be conducted on the initial production units/lots/batches to ensure that the devices conform to defined user needs and intended use.
    • The design validation must include:
      • Testing under actual or simulated use condition
      • Software validation (where appropriate)
      • Risk management (where appropriate)
    • The result of design validation must be documented in the DHF, including the identification of the design, method(s), date, and individual(s) performing the validation.
  • Design transfer procedures must ensure that design transfer correctly into production specifications.
  • Before design changes are implemented, they must be:
    • Identified
    • Documented
    • Validated and/or verified
    • Reviewed
    • And approved.
  • Each manufacturer must establish and maintain a DHF to demonstrate conformance to the approved design plans and other requirements listed above.

Document Controls (Subpart D 820.40)

TL; DR: The Document Controls procedure is similar to the Control of Documents and Control of Records (Section 4.2.4 and 4.2.5) of the ISO 13485:2016. Essentially, documents must be kept up to date. Any changes made must be approved and documented.

  • The manufacturer must establish and maintain procedures for document controls, including:
    • Document must be reviewed for adequacy, approved (dated and signed by authorized individual(s)), and distributed to relevant function and personnel. Obsolete documents must be removed or kept from use.
    • Document changes must be recorded, reviewed, approved, communicated to relevant personal. Records for document changes include a description of change, identification of the affected documents, signature of approving individual(s), approval date, and effective date.

Design History File – Device Master Record – Device History Record (Subpart M 820.181,184)

TL; DR: DHF is a summation record of all Design and Developing actions, from planning to transferring, including any changes. DMR contains, or references, all specifications regarding the device and related processes (production, quality assurance, post-delivery activities, etc.). DHR make sure the device is manufactured according to the requirements in the DMR.

Note: DHF + DMR = Medical device file (required by ISO 13485:2016); DHR is not required by ISO 13485:2016.

DHF – Design history file (820.30):

  • Manufacture must maintain a DHF for each type of device. DHF must contain or reference to necessary records demonstration conformance to the approved design plan and the requirements of design controls (820.30).
  • Typically, DHF contains:
    • Approved design and development (D&D) plan in detail with D&D activities, responsibility, deliverables (criteria), etc.
    • Documents of approved D&D inputs, outputs, and reviews.
    • Documents of procedures for design validation and verification.
    • Documents of records control (and change control)
    • Any other documents proving the device was designed according to the established plan.

DMR – Device master record:

  • Manufacture must maintain a DMR for each type of device according to the requirements from Document Controls (820.40).
  • DMR must include, as appropriate, the following information (or reference its location):
    • Device specifications (drawings, composition, formulation, and specifications for components and software)
    • Production process specifications (specifications of equipment, method, procedure, and production environment)
    • Quality assurance procedures and specifications (acceptance criteria, involved quality assurance equipment).
    • Installation, maintenance, servicing methods and procedures.
    • Specifications for labeling and packaging.

DHR – Device history record:

  • Manufacture must maintain DHR for each batch, lot, or unit to demonstrate that the device is manufactured in accordance with the DMR.
  • DHR must include, as appropriate, the following information (or reference its location):
    • The dates of manufacture
    • The quantity of manufactured
    • The quantity released for distribution.
    • The acceptance records demonstrating conformance to the DMR.
    • The primary identification label and labeling used for each production unit.
    • Any unique device identifier (UDI), universal product code (UPC), and any other device identification(s) and control number(s) used.

Quality System Record (QSR) (Section 820.186)

TL; DR: The manufacture must maintain records of the specifications for the Quality Management System.

  • Manufacture must maintain a QSR in accordance with the requirements of Document Controls (Section 820.40).
  • QSR must include, or reference to the location of, procedures and documentation of activities that are not specific to a particular type of device, such as:
    • Quality policy (demonstrating the company’s commitment to quality)
    • Organizational structure (responsibility and authority, resources, and management representative)
    • Management review
    • Quality planning
    • Quality system procedures.

Complaint Files (Section 820.19)

TL; DR: Manufacturing must maintain records, review, and investigate (if deem necessary) complaints regarding the device, as well as report to the FDA when required.

  • Manufacturer must maintain complaint files.
  • Manufacturer must establish and maintain procedures for receiving, reviewing, and evaluating complaints by a formal unit to ensure that:
    • All complaints are handled uniformly and promptly.
    • Oral complaints are documented upon receipt.
    • Complaints are evaluated to determine if:
      • Report to FDA is required according to Medical Device Reporting (Part 803)
      • Investigation is necessary, or justification for the lack thereof.
  • Complaints representing possible failure of a device, labeling, and packaging must be investigated.
  • Complaints requiring report to FDA must be handled by a formally designated unit, and must include:
    • Determination if:
      • The device failed to meet specifications
      • The device was being used for treatment or diagnosis
      • The connection between the device and the reported/adverse event.
    • The name of the device
    • The date the complaint was received
    • The device identifier (UDI, UPC, or any other)
    • The name, address, and phone number of complainant
    • The nature and details of the complaint
    • The dates and results of investigation
    • Any correct action taken, or any reply to the complainant
  • If the unit handling complaint is outside/ separate from the manufacturing establishment, reasonable access to the complaints and records from investigation must be arranged.
  • If the unit handling complaint is outside of the United State, complaints and records from investigation must be accessible at a domestic location where the manufacture’s records are regularly kept, or the location of the initial distributor.

–The End–

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