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FDA QSR (Quality System Regulation)

Regulation for Your Medical Protection
By Richard Triplett, Risk Control Technology Specialist

Executive Summary

How do you know if the medical device that you may use, or that may be used on you has
been manufactured according to established quality procedures? Who is watching out for
the consumer to make certain such items are manufactured to formal quality procedures? Is
each product manufactured using the same quality standards? We may never think about
these issues in the event of a medical emergency or in need of routine medical care, but
extensive planning has been required in the development and manufacturing of medical
devices and pharmaceutical products for your protection.
The Food and Drug Administration (FDA) is the regulatory agency for the United States
Department of Health and Human Services responsible for the regulation of drugs, medical
devices, food, biologics and radiation-emitting devices. They are also responsible for the
regulation of human cosmetics, animal feed and animal drugs1. The FDA is under the
direction of the Commissioner of Food and Drug, who is appointed by the President of the
United States with the advice and consent of the U.S. Senate. The appointed Commissioner
reports directly to the Secretary of Health and Human Services2.
The regulations that are enforced by the FDA are written as part of the Code of Federal
Regulations (CFR) Title 21 Food and Drugs. As part of the CFR Title 21, Part 820 deals
specifically with Quality System Regulations (QSR).

What is CFR Title 21

Part 820?

Title 21 of the Code of Federal Regulations (commonly know as FDA 21 CFR Part 820 or
Quality System Regulation, QSR) outlines Current Good Manufacturing Practice (CGMP)
requirement that govern the methods used in, and facilities and controls used for, the
design, manufacturing, packaging, labeling, storage, installation and servicing of all finished
devices for human use. 3
The FDA, in Title 21 Part 820, does not write the QSRs specifically for each manufacturer
but provides the governing requirements that must be followed. It is the responsibility of the
manufacturer to ensure that compliance of the QSR standards is being followed for the
consumers safety and to make certain that the devices are effective for their intended
usage.
In 1990, the FDA started a revision of the CGMP regulation to include design controls
authorized by the Safe Medical Device Act and believed that it would be beneficial for the
quality standards to be harmonized with the international standards for quality systems4.

This article is provided for general informational purposes only and does not constitute and is not intended to take the place of legal or
risk management advice. Readers should consult their own counsel or other representatives for any such advice. Any and all external
websites or sources referred to herein are for informational purposes only and are not affiliated with or endorsed by OneBeacon Insurance
Group. OneBeacon Insurance Group hereby disclaims any and all liability arising out of the information contained herein.

FDA QSR (Quality System Regulation)

The two primary international standards which are recognized are: International
Organization for Standards (ISO) 9001:1994 Quality Systems Model for Quality Assurance
in Design, Development, Production, Installation, and Servicing and ISO 13485 Quality
Systems Medical Devices.
A very important part of the CGMP is the first letter C which stands for Current.
Manufacturers are required to make certain that their manufacturing practices are kept
current for the consumers safety and device effectiveness. Practices that were followed
years ago may no longer be good practices and need to be updated to current
manufacturing standards.

QSR Components

The QSR is composed of many regulation/practices that must be followed to ensure

compliance of the governing requirements. These regulation/practices will include:5

Design controls

Component Selection

Labeling Content

Process Quality

Management Responsibility

Formal and Documented Quality Systems

Approval of Product

Quality Acceptance Activities

Quality System Audits

Employee Training

Quality Systems Maintenance

Medical Device Reporting

After a QSR is in place, the written procedures must be updated with continuous monitoring
by management. Management must display a serious commitment to quality. This
commitment must also be demonstrated by each employee to ensure that the product is
manufactured to an acceptable level of quality. Monitoring can be completed by system
audits, management reviews and corrective and preventive actions (CAPA)6.
Title 21 Subpart B Quality Systems Requirements Section 820.20 defines Quality Policy as
follows: Management with executive responsibility 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. 7

Effectiveness of QSR

Individuals representing the FDA who are specifically trained on CGMP (QSR) regulations will
conduct inspections of medical device manufacturers. The FDA also relies on information
provided by the general public on medical devices that have had issues or suspected
problems. These are documented in the FDAs publicly accessible database and are called
Adverse Event Reports (AER). Following an inspection, companies that are not in compliance
This article is provided for general informational purposes only and does not constitute and is not intended to take the place of legal or
risk management advice. Readers should consult their own counsel or other representatives for any such advice. Any and all external
websites or sources referred to herein are for informational purposes only and are not affiliated with or endorsed by OneBeacon Insurance
Group. OneBeacon Insurance Group hereby disclaims any and all liability arising out of the information contained herein.

FDA QSR (Quality System Regulation)

with the requirements of CFR 21 are issued a 483. Failure to comply with the 483 within the
designated timeframe will result in an FDA Warning Letter. For the first half of the fiscal
year 2012 (October 1, 2011 - March 15, 2012), a total of 81 Warning Letters were issued by
the Center for Device and Radiological Health (CDRH). Of the 81 Warning Letters issued, 68
letters referred to CGMP (QSR) requirements for medical devices in 21 CFR 820. The top
five deficiencies listed in order of frequency were deficiencies with/in:8

Importance of a
QSR (cGMP)

Corrective and Preventive Action

Complaint Files

Design Control

Purchasing Controls

Receiving, In-Process and Finish Device Acceptance

Most consumers will have difficulty determining if an FDA registered medical device has
been manufactured to a high quality standard each and every time. Requiring medical
device manufacturers to develop and maintain a QSR ensures that they are following
stringent and defined quality standards and procedures, and manufacturing a product
correctly each time. A QSR would address product defects or problems to minimize its
detrimental effects on the end-user. Random FDA inspections only offer a snapshot in time
of a manufacturers QSR process. What is important is that manufacturing is completed
under practices and physical facility conditions that follow CGMP regulations, and that these
practices are built into each phase of the manufacturing process for the consumers safety.
Without the elements of a good CGMP/QSR, both the FDA and consumer may not be
informed about potential product problems or defects that may have a detrimental effect on
the safe usage of the product.

Conclusion

This paper provides a brief, high-level overview of a highly complex process. Quality
Systems Regulations are an FDA requirement for medical devices and pharmaceutical
products. Although the consumer may likely never be aware of these practices, the FDA
requirement that medical device and pharmaceutical manufactures comply with QSR
ensures that the product is designed and manufactured to a high quality standard. QSR also
requires the manufacturer to have processes in place to handle recordkeeping, recall and
corrective action that address product defects proactively once they have entered the
stream of commerce. This ensures that the consumer is using a product that is expected to
be of the highest quality. Ultimately, Total quality systems extend from customer
requirements through development and production to customer use and feedback. Thus
total quality systems encompass medical device law and regulations, particularly the QS
regulations.9

Contact Us

To learn more about how OneBeacon Technology Insurance can help you manage online
and other technology risks, please contact Lloyd Takata, SVP of OneBeacon Technology
Insurance at [email protected] or 952.852.6028.

This article is provided for general informational purposes only and does not constitute and is not intended to take the place of legal or
risk management advice. Readers should consult their own counsel or other representatives for any such advice. Any and all external
websites or sources referred to herein are for informational purposes only and are not affiliated with or endorsed by OneBeacon Insurance
Group. OneBeacon Insurance Group hereby disclaims any and all liability arising out of the information contained herein.

FDA QSR (Quality System Regulation)

References

1 http://www.advamedegcc.org/download/File/white_papers/WP__Reg_Compliance_Med_Devices.pdf, page 2
2 http://en.wikipedia.org/wiki/Food_and_Drug_Administration
3 Ibid 1, page 2
4
http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/PostmarketRequireme
nts/QualitySystemsRegulations/default.htm
5
http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/PostmarketRequireme
nts/QualitySystemsRegulations/MedicalDeviceQualitySystemsManual/ucm122368.htm
6 Ibid 5
7
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=820&sh
owFR=1

8 GMP News 06/06/2012: http://www.gmpcompliance.org/eca_news_3160_7298,7381,7335_rss.html, Sven Pommeranz

9 Ibid 5

This article is provided for general informational purposes only and does not constitute and is not intended to take the place of legal or
risk management advice. Readers should consult their own counsel or other representatives for any such advice. Any and all external
websites or sources referred to herein are for informational purposes only and are not affiliated with or endorsed by OneBeacon Insurance
Group. OneBeacon Insurance Group hereby disclaims any and all liability arising out of the information contained herein.