Regulatory Aspects Of Medical Device
(PHRGA016)
21 CFR Part 820 Quality System
Regulation of Medical Devices
PRESENTED BY:
DIYA PATEL
24MPHRGA014
SEM 2 [Link]
Table of Content
SUBPART
A to O CONCLUSION
INTRODUCTION REFERENCES
(21 CFR part 820)
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Quality system regulation 21 CFR Part 820
Each manufacturer shall establish and maintain a quality system that is appropriate
for the specific medical device(s) designed or manufactured, and that meets the
requirements of this part.
The FDA's quality system regulation (QSR) as defined in 21 CFR Part 820 states
that manufacturers should establish and follow a quality system to help ensure that
their products consistently meet applicable requirements and specifications.
There are total 15 subparts named as A to O.
Subpart B is specific for quality system requirements.
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Subpart A:General Provisions
SCOPE APPLICABILITY DEFINITIONS QUALITY
SYSTEM
This part outlines the It specifies that the Subpart A Each
scope of the regulation applies to provides manufacturer shall
regulation, indicating manufacturers who definitions for establish and
that it applies to commercially important terms maintain a quality
manufacturers of distribute medical used in Part 820, system that is
finished medical devices in the ensuring appropriate for the
devices. United States, consistent specific medical
including those interpretation and device(s) designed
imported for understanding of or manufactured,
commercial the regulation. and that meets the
distribution. requirements of
this part.
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Subpart B: Quality System Requirements
S
U 820.20 Management
B Responsibility
P
A 820.22 Quality Audit
R
T
820.25 Personnel
B
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Section. 820.20 Management Responsibility
A. Quality Policy:
Shall establish its policy and objectives for, and commitment to, quality. Management
with executive responsibility shall ensure that the quality policy is understood,
implemented, and maintained at all levels of the organization.
B. Organization:
Each manufacturer shall establish and maintain an adequate organizational structure to
ensure that devices are designed and produced in accordance with the requirements.
1. Responsibility and authority:
Each manufacturer shall establish the appropriate responsibility, authority, and
interrelation of all personnel who manage, perform, and assess work affecting quality,
and provide the independence and authority necessary to perform these tasks. 6
2. Resources:
Each manufacturer shall provide adequate resources, including the assignment of
trained personnel, for management, performance of work, and assessment activities,
including internal quality audits, to meet the requirements.
3. Management Representative:
Management with executive responsibility shall appoint, and document such
appointment of, a member of management who, irrespective of other
responsibilities, shall have established authority over and responsibility for,
Ensuring that quality system requirements are effectively established and
effectively maintained.
Reporting on the performance of the quality system to management with executive
responsibility for review.
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C. Management Review:
Shall review the suitability and effectiveness of the quality system at defined
intervals and with sufficient frequency according to established procedures.
D. Quality Planning:
The manufacturer shall establish how the requirements for quality will be met.
E. Quality System Procedure:
An outline of the structure of the documentation used in the quality system shall be
established where appropriate. 8
Section. 820.22 Quality Audit
Each manufacturer shall establish procedures for quality audits and conduct such
audits to assure that the quality system is in compliance with the established quality
system requirements and to determine the effectiveness of the quality system.
Quality audits shall be conducted by individuals who do not have direct
responsibility for the matters being audited.
A report of the results of each quality audit, and reaudit(s) where taken, shall be
made and such reports shall be reviewed by management.
The dates and results of quality audits and reaudits shall be documented.
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Section. 820.25 Personnel
A. General:
Each manufacturer shall have sufficient personnel with the necessary education, background,
training, and experience to assure that all activities required by this part are correctly performed.
B. Training:
Each manufacturer shall establish procedures for identifying training needs and ensure that all
personnel are trained to adequately perform their assigned responsibilities.
Training shall be documented.
1. As part of their training, personnel shall be made aware of device defects which may occur
from the improper performance of their specific jobs.
2. Personnel who perform verification and validation activities shall be made aware of defects
and errors that may be encountered as part of their job functions. 10
Subpart C:Design controls
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Subpart D:Document controls
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Subpart E:Purchasing controls
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Subpart F:Identification and Traceability
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Subpart G:Production and Process Controls
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Subpart H:Acceptance Activities
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Subpart I:Nonconforming Product
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Subpart J:Corrective and Preventive Action
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Subpart K:Labeling and Packaging Control
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Subpart L:Handling, Storage, Distribution,
and Installation
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Subpart M:Records
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Subpart N:Servicing
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Subpart O:Statistical Techniques
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Conclusion
Quality System Regulation 21 CFR Part 820 outlines rules for medical device
manufacturers to ensure products are safe and effective. It covers processes like
design, production, testing, and labeling. Compliance is crucial for making sure
medical devices meet quality standards and are safe for use by patients.
Manufacturers must establish and maintain robust quality management systems to
comply with quality system requirements. Compliance not only allows for market
access but also ensures patient safety and enhances the overall quality of medical
devices in the United States.
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References
1. 21 CFR part 820 -- quality system regulation [Internet]. [Link]. [cited 2025 Apr
25]. Available from: [Link]
H/part-820
25
Thank you
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