Rio Salado College Improvement in Medical Devices Quantity Variety and Complexity Paper

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