Description
The course covered the regulatory framework in the U.S. for medical device development throughout the product lifecycle. We reviewed the different routes to market, quality testing and quality design, device classification, FDA actions, and post-market surveillance.
Reflection paper 500 words max
APA Format
Learning Objectives:
- Summarize the history of US medical device regulations
- Identify the FDA regulations and guidance’s applicable to the development of medical devices
- Identify medical devices in the three classifications.
- Apply the device controls to determine device classification.
- Identify various materials used in the design of medical devices and concerns/issues with the materials.
- Device Classification
- Medical Device Definition
- Classification by Risk
- Class I – General Controls
- Cass II – General Controls + Special Controls
- Class III – General Controls + Special Controls + Proof of Safety & Efficacy
- Panels and device subsets by medical specialties http://www.fda.gov/medicaldevices/deviceregulation...
- Format of device classification
- Examples of Class I, II & III devices
- Enforcement of CFRs
- Define predicate devices and substantial equivalence.
- Describe the use of predicate devices and substantial equivalence in medical device development and submission of 510(k) applications to the FDA.
- Summarize the 510(k) route to market.
- Summarize the PMA application process for marketing approval of a device
- Define IDEs and the requirements of clinical trials to prove safety and efficacy
- Describe the required contents of the PMA.
- Define and describe the actions the FDA can take when reviewing and approving PMAs.
- Discuss the importance of communication and meetings with the FDA during the PMA submission process.
- Define combination medical devices and explain Primary Mode of Action
- Identify and explain the importance of meetings and communication with the FDA during the submission process.
- Analyze safety issues with medical devices and identify tests, assessments, and steps to prevent the safety issue.
- Discuss the need for and types of postmarket surveillance of medical products.
- Describe and discuss CAPAs.
- Identify and describe the contents of the sections of a 510(k) application
Explanation & Answer
Please view explanation and answer below.
Outline
1. Introduction
2. History of US Medical Device Regulations
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Food, Drug and Cosmetics Act 1906
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Medical Device Amendments 1960s and 1970s
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Center for Devices and Radiological Heath 1982
3. FDA Regulations and Guidance
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Electronic registrations of establishments
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Medical device listings
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Premarket notification 510(k)
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Premarket approval
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Investigational device exemption
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Labeling
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Reporting incidences
4. Classification, controls and examples
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Class I devices- low risk -general control
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Class II devices – higher risk-general and special controls
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Class III devices -highest risk – general and special controls + PMA
5. Panels, Format of Classification, and Codes of Federal Regulations (CFR)
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CFR Title 21, Sections 862-892
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Format of classification
6. Predicate devices, Substantial Equivalence and 510(k) Application
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Definition of predicate devices
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Definition of substancial equivalence
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Predicate devices and substancial use in 510(k) application
7. IDEs and Clinical trial requirements
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Definition of IDE
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Requirements
8. PMA, FDA’s Action and Importance of meeting and Communication
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Requirements
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Actions
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Addressing unsatisfactory reviews
9. Combination Medical Devices and Primary Mode of Action
10. Importance of Communication
11. Conclusion
12. References
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Reflection paper: Regulatory Framework for Medical Device Development
Student’s Name
Institution
Course
Date
2
Reflection on Regulatory Framework for Medical Device Development
There has been an improvement in medical devices' quantity, variety, and complexity in
the last two decades. The need to have a steady regulatory outlook called for an evolution in the
modulation of medical devices. This reflective essay intends to look into the history of medical
devices regulations, diverse ways to market, test quality and quality design, classification of
devices, FDA actions, and post-market surveillance. The purpose is to enlighten me and others
on what was studied in class and was not known before.
History of U.S. Medical Device Regulations
In 1906, the Food and Drugs Administration's surveillance began after President
Theodore underwrote the Pure Food and Drugs Act. Ever since, Congress has diversified the role
of the FDA in safeguarding and enhancing the evolution of drugs and food for humans and
animals, medical devices, radioactive products, and cosmetics. By pronouncing the Medical
Device Amendments (MDA) to the Federal Food, Drug, and Cosmetics Act (FFDCA) in the
1960s and 1970s, Congress answered the public's wish to have added surveillance of medical
devices. The formation of the Center for Devices and Radiological Health (CDRH) in 1982
resulted from unifying FDA organizational units that modulated medical devices and radioactive
produ...