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N G S M Institute of Pharmaceutical Sciences
DEPT OFPHARMACEUTICAL REGULATORY AFFAIRS
REGULATORY ASPECTS OF MEDICAL DEVICES
N.G.S.M.INSTITUTE OF PHARMACEUTICAL SCIENCES,
NITTE (DEEMED to be UNIVERSITY)
MANGALORE
- SWAPNIL D.FERNANDES
QUALITY SYSTEMREQUIREMENTS21 CFRPART 820 AND
LABELLINGREQUIREMENTSFORMEDICALDEVICES
N G S M Institute of Pharmaceutical Sciences
21 CFR Part 820 – Quality Management System
• Whatis a QualityManagementSystem ?
– A quality management system (QMS) is a collection of business
processes focused on consistently meeting customer requirements and
enhancingtheir satisfaction.
– It is aligned with an organization's purpose and strategic direction.
N G S M Institute of Pharmaceutical Sciences
Background
EffectiveJune1, 1997, replacing the 1978 GMPfor medical devices
GMP formedical devices
Preamble tothe 1997 regulation -VERY Important
Important
Requirementsare notprescriptive
Provides frameworkof basic requirementsfor manufacturersto
manufacturersto follow
N G S M Institute of Pharmaceutical Sciences
QMS : A Necessity
• All domestic andforeign manufacturers of medical devices
intended for sale in the US must have aquality management
system inplace.
• A manufacturer must develop a Quality Management System
(QMS) commensurate with:
–risk presented by the device
–complexity of device and manufacturingprocesses
–size and complexity of organization
N G S M Institute of Pharmaceutical Sciences
Key Elements
A. General Provisions
B. Quality System
Requirements
including
Management
responsibility
C. Design Control
D. Document Control
E. Purchasing Control
F. Product Identification
and Traceability.
G. Controlling and
defining production
and process.
H. Product Acceptance
I. Controlling non-
conformance products.
J. Instituting CAPA.
N G S M Institute of Pharmaceutical Sciences
K. Labelling and Packaging Controls.
L. Handling, Storage, Distribution and
Installation.
M. Records
N. Servicing
O. Statistical Techniques.
N G S M Institute of Pharmaceutical Sciences
Quality System Inspection Technique
• Technique/Plan for
investigators to follow.
• Evaluation of Medical
Device manufacturers
compliance with QMS
requirements.
N G S M Institute of Pharmaceutical Sciences
N G S M Institute of Pharmaceutical Sciences
Elements of Management Subsystem
Management
Responsibility
(820.20)
Quality Audits
(820.22)
Training
(820.25)
N G S M Institute of Pharmaceutical Sciences
Elements of Design ControlElements of Design Control
Design
Controls
introduction.
(820.30)
Product and
Process
Changes
(820.70)
Device
Master
Record
(820.181)
Statistical
Techniques
(820.250)
N G S M Institute of Pharmaceutical Sciences
Elements ofCAPA
• Covers:
– CAPA procedures established.
– Management reviews of the CAPA activities.
– Statistical Analysis of Data sources for CAPA.
– Investigations conducted to identify root-cause of
failures.
N G S M Institute of Pharmaceutical Sciences
Elements of Production
and Process Control
• Checks whether –
– Manufacturing processes are validated and controlled.
– Software is validated.
– Equipment is validated.
• Production employee training and qualified.
• Suppliers – certified and audited.
N G S M Institute of Pharmaceutical Sciences
LABELLING REQUIREMENTS OF MEDICAL
DEVICES.
N G S M Institute of Pharmaceutical Sciences
What is a “Label”?
• A display of written, printed, or graphic matter
upon the immediate container of any article.
• Any word, statement, or other information that
appears on the label shall also appear on the
outside container or wrapper of the retail package
or is easily legible through the outside container
or wrapper
Section 201(k) of FD&C Act
N G S M Institute of Pharmaceutical Sciences
What is “Labelling”?
• All labels and other written, printed, or
graphic matter
–upon any article or any of its containers or
wrappers
–or accompanying such article
Section 201(m) of FD&C Act
N G S M Institute of Pharmaceutical Sciences
Labelling Regulations
• Labelling regulations pertaining to medical devices are
found in the following parts of Title 21 of the Code of
Federal Regulations.
– GeneralDeviceLabelling: 21CFR Part 801
– In VitroDevice Labelling:21CFR Part 809
– InvestigationalDeviceExemptions:21 CFR Part 812
N G S M Institute of Pharmaceutical Sciences
U.S. MinimalLabelling
Requirements
• Must be includedonthe package label
–Name and place of manufacturer,packer or distributor.
–Adequate directions for use under which the layman can use a
device safely for intendedpurposes
• Required informationmustbe displayedprominentlyon
the device label
N G S M Institute of Pharmaceutical Sciences
U.S. Minimal Labelling
Requirements
• Exemptionsto prominence may be granted ifdevice
labellinglackssufficientspace
• Labellingmust be in English
• More specificlabellingrequirements for specificdevices
21 CFR 801.403
N G S M Institute of Pharmaceutical Sciences
Exemptions from Adequate
Directions for Use
• Prescription devices are exempt form “adequate directions for
use”, provided:
– Device is inpossession ofa licensedpractitioner
– Labellinghas a Rxstatement
– Labellingincludes informationfor use
– Alllabellingother than labelsandcartons includes thedateof
issuance or dateof thelatestrevision
21 CFR 801.109
N G S M Institute of Pharmaceutical Sciences
Labelling Requirements: Types
of Submissions
• 510(k)
• IDE
• PMA
• In Vitro Diagnostics
N G S M Institute of Pharmaceutical Sciences
• 510(k) - 21 CFR 807.87(e)
• IDE Labelling – 21 CFR 812.5
• PMA Labelling - 21 CFR 814.20(b)(10)
• IVD Labelling - 21 CFR 809.10
N G S M Institute of Pharmaceutical Sciences
CONCLUSION
• Medical Device manufacturing companies must have
an effective QMS in place.
• FDA audits quality systems based on subsystems
framework.
• Management involvement is vital.
• Requirements for the label and the labelling are
found in 21 CFR Parts 801, 809, 812, and 820.
• All devices have some of the same general
requirements.
• Additional labelling requirements depend on the
submission type.
N G S M Institute of Pharmaceutical Sciences
REFERENCES
• CFR - Code of Federal Regulations Title 21 [Internet]. Accessdata.fda.gov. 2018
[cited 1 April 2018]. Available from:
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CF
RPart=820
• Fries R. Handbook of medical device design. New York: M. Dekker; 2001.
• Bsigroup.com. 2018 [cited 1 April 2018]. Available from:
https://www.bsigroup.com/meddev/LocalFiles/en-IL/Services/BSI-md-iso-
13485-qms-brochure-UK-EN.pdf
• Fda.gov. 2018 [cited 1 April 2018]. Available from:
https://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/Small
BusinessAssistance/UCM466493.pdf
N G S M Institute of Pharmaceutical Sciences
• Labelling. Rockville, Md.: U.S. Dept. of Health and Human
Services, Public Health Service, Food and Drug
Administration, Centre for Devices and Radiological
Health; 1986.
• Mechcatie E. Identification Labelling System For Medical
Devices Is Proposed. Skin & Allergy News. 2012;43(8):10.
• Siegel SJ T. FDA Regulation of Medical Devices and
Medical Device Reporting. Pharmaceutical Regulatory
Affairs: Open Access. 2013;02(02).
• CFR - Code of Federal Regulations Title 21 [Internet].
Accessdata.fda.gov. 2018 [cited 1 April 2018]. Available
from:
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr
/CFRSearch.cfm?CFRPart=801

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Quality System Requirements 21 CFR Part 820 and Labelling Requirements for Medical Devices 21 CFR Part 801

  • 1. N G S M Institute of Pharmaceutical Sciences DEPT OFPHARMACEUTICAL REGULATORY AFFAIRS REGULATORY ASPECTS OF MEDICAL DEVICES N.G.S.M.INSTITUTE OF PHARMACEUTICAL SCIENCES, NITTE (DEEMED to be UNIVERSITY) MANGALORE - SWAPNIL D.FERNANDES QUALITY SYSTEMREQUIREMENTS21 CFRPART 820 AND LABELLINGREQUIREMENTSFORMEDICALDEVICES
  • 2. N G S M Institute of Pharmaceutical Sciences 21 CFR Part 820 – Quality Management System • Whatis a QualityManagementSystem ? – A quality management system (QMS) is a collection of business processes focused on consistently meeting customer requirements and enhancingtheir satisfaction. – It is aligned with an organization's purpose and strategic direction.
  • 3. N G S M Institute of Pharmaceutical Sciences Background EffectiveJune1, 1997, replacing the 1978 GMPfor medical devices GMP formedical devices Preamble tothe 1997 regulation -VERY Important Important Requirementsare notprescriptive Provides frameworkof basic requirementsfor manufacturersto manufacturersto follow
  • 4. N G S M Institute of Pharmaceutical Sciences QMS : A Necessity • All domestic andforeign manufacturers of medical devices intended for sale in the US must have aquality management system inplace. • A manufacturer must develop a Quality Management System (QMS) commensurate with: –risk presented by the device –complexity of device and manufacturingprocesses –size and complexity of organization
  • 5. N G S M Institute of Pharmaceutical Sciences Key Elements A. General Provisions B. Quality System Requirements including Management responsibility C. Design Control D. Document Control E. Purchasing Control F. Product Identification and Traceability. G. Controlling and defining production and process. H. Product Acceptance I. Controlling non- conformance products. J. Instituting CAPA.
  • 6. N G S M Institute of Pharmaceutical Sciences K. Labelling and Packaging Controls. L. Handling, Storage, Distribution and Installation. M. Records N. Servicing O. Statistical Techniques.
  • 7. N G S M Institute of Pharmaceutical Sciences Quality System Inspection Technique • Technique/Plan for investigators to follow. • Evaluation of Medical Device manufacturers compliance with QMS requirements.
  • 8. N G S M Institute of Pharmaceutical Sciences
  • 9. N G S M Institute of Pharmaceutical Sciences Elements of Management Subsystem Management Responsibility (820.20) Quality Audits (820.22) Training (820.25)
  • 10. N G S M Institute of Pharmaceutical Sciences Elements of Design ControlElements of Design Control Design Controls introduction. (820.30) Product and Process Changes (820.70) Device Master Record (820.181) Statistical Techniques (820.250)
  • 11. N G S M Institute of Pharmaceutical Sciences Elements ofCAPA • Covers: – CAPA procedures established. – Management reviews of the CAPA activities. – Statistical Analysis of Data sources for CAPA. – Investigations conducted to identify root-cause of failures.
  • 12. N G S M Institute of Pharmaceutical Sciences Elements of Production and Process Control • Checks whether – – Manufacturing processes are validated and controlled. – Software is validated. – Equipment is validated. • Production employee training and qualified. • Suppliers – certified and audited.
  • 13. N G S M Institute of Pharmaceutical Sciences LABELLING REQUIREMENTS OF MEDICAL DEVICES.
  • 14. N G S M Institute of Pharmaceutical Sciences What is a “Label”? • A display of written, printed, or graphic matter upon the immediate container of any article. • Any word, statement, or other information that appears on the label shall also appear on the outside container or wrapper of the retail package or is easily legible through the outside container or wrapper Section 201(k) of FD&C Act
  • 15. N G S M Institute of Pharmaceutical Sciences What is “Labelling”? • All labels and other written, printed, or graphic matter –upon any article or any of its containers or wrappers –or accompanying such article Section 201(m) of FD&C Act
  • 16. N G S M Institute of Pharmaceutical Sciences Labelling Regulations • Labelling regulations pertaining to medical devices are found in the following parts of Title 21 of the Code of Federal Regulations. – GeneralDeviceLabelling: 21CFR Part 801 – In VitroDevice Labelling:21CFR Part 809 – InvestigationalDeviceExemptions:21 CFR Part 812
  • 17. N G S M Institute of Pharmaceutical Sciences U.S. MinimalLabelling Requirements • Must be includedonthe package label –Name and place of manufacturer,packer or distributor. –Adequate directions for use under which the layman can use a device safely for intendedpurposes • Required informationmustbe displayedprominentlyon the device label
  • 18. N G S M Institute of Pharmaceutical Sciences U.S. Minimal Labelling Requirements • Exemptionsto prominence may be granted ifdevice labellinglackssufficientspace • Labellingmust be in English • More specificlabellingrequirements for specificdevices 21 CFR 801.403
  • 19. N G S M Institute of Pharmaceutical Sciences Exemptions from Adequate Directions for Use • Prescription devices are exempt form “adequate directions for use”, provided: – Device is inpossession ofa licensedpractitioner – Labellinghas a Rxstatement – Labellingincludes informationfor use – Alllabellingother than labelsandcartons includes thedateof issuance or dateof thelatestrevision 21 CFR 801.109
  • 20. N G S M Institute of Pharmaceutical Sciences Labelling Requirements: Types of Submissions • 510(k) • IDE • PMA • In Vitro Diagnostics
  • 21. N G S M Institute of Pharmaceutical Sciences • 510(k) - 21 CFR 807.87(e) • IDE Labelling – 21 CFR 812.5 • PMA Labelling - 21 CFR 814.20(b)(10) • IVD Labelling - 21 CFR 809.10
  • 22. N G S M Institute of Pharmaceutical Sciences CONCLUSION • Medical Device manufacturing companies must have an effective QMS in place. • FDA audits quality systems based on subsystems framework. • Management involvement is vital. • Requirements for the label and the labelling are found in 21 CFR Parts 801, 809, 812, and 820. • All devices have some of the same general requirements. • Additional labelling requirements depend on the submission type.
  • 23. N G S M Institute of Pharmaceutical Sciences REFERENCES • CFR - Code of Federal Regulations Title 21 [Internet]. Accessdata.fda.gov. 2018 [cited 1 April 2018]. Available from: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CF RPart=820 • Fries R. Handbook of medical device design. New York: M. Dekker; 2001. • Bsigroup.com. 2018 [cited 1 April 2018]. Available from: https://www.bsigroup.com/meddev/LocalFiles/en-IL/Services/BSI-md-iso- 13485-qms-brochure-UK-EN.pdf • Fda.gov. 2018 [cited 1 April 2018]. Available from: https://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/Small BusinessAssistance/UCM466493.pdf
  • 24. N G S M Institute of Pharmaceutical Sciences • Labelling. Rockville, Md.: U.S. Dept. of Health and Human Services, Public Health Service, Food and Drug Administration, Centre for Devices and Radiological Health; 1986. • Mechcatie E. Identification Labelling System For Medical Devices Is Proposed. Skin & Allergy News. 2012;43(8):10. • Siegel SJ T. FDA Regulation of Medical Devices and Medical Device Reporting. Pharmaceutical Regulatory Affairs: Open Access. 2013;02(02). • CFR - Code of Federal Regulations Title 21 [Internet]. Accessdata.fda.gov. 2018 [cited 1 April 2018]. Available from: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr /CFRSearch.cfm?CFRPart=801

Editor's Notes

  1. It is expressed as the organizational goals and aspirations, policies, processes, documented information and resources needed to implement and maintain it. In simple terms, a QMS is a system of checks and balance to ensure the safety and effectiveness of medical devices.
  2. G- including validation. H – For incoming, in process and finished products. J – when errors occurs, defining the errors and establishing adequate measures for correcting and preventing them.
  3. QSIT instructs auditors to focus on 4 subsystems: Management Design Control Corrective and Preventive Action Production and Process Control The other subsystems are covered through links to the main subsystems – Records, Documents, Change Controls – Linked through all the main subsystems Facility and Equipment Control, Material Control – Linked through Production and Process Controls.
  4. Quality Policy must be in place. Management representative appointed as the responsible person for QS. Management reviews are the an integral part of the QS. Apart from this, Quality audit procedures, Quality system procedures. Also, quality audits should be conducted at pre-defined intervals.
  5. Design Controls – Includes – Design review, Design verification and Design Validation. Upon the effective use of these three subprocesses, the design transfer to manufacturing will take place successfully. Device Master records (DMR) and Design History File (DHF) are created as a part of Design Control. DMR – a file that compiles all records of procedures and specifications for a finished product It also contains documents on how to perform all functions related to the production of a product. DHF- document that verifies that the product has been designed as per approved design plan. Only one DHF per product, which can be updated at later stages.
  6. Including the street address, city, state and zip code
  7. A 510(K) is a premarket submission made to FDA to demonstrate that the device to be marketed is at least as safe and effective, that is, substantially equivalent, to a legally marketed device. An investigational device exemption (IDE) allows the investigational device to be used in a clinical study in order to collect safety and effectiveness data. Premarket approval (PMA) is the FDA process of scientific and regulatory review to evaluate the safety and effectiveness of Class III medical devices i.e. A Class III device is one for which insufficient information exists to assure safety and effectiveness solely through the general or special controls sufficient for Class I or Class II devices..
  8. 510(k) - Submission should include the proposed labels, labelling, and advertisements sufficient to describe: • the device its intended use the directions for its use, if applicable – pics and engineering drawings also should be supplied. IDE Labelling - General Labelling Requirements apply, This statement: “CAUTION: Investigational Device. Limited by Federal (or United States) law to investigational use.” PMA Labelling - Submissions should include copies of all proposed labelling for the device. Instructions for installation, if any required.