Designing Medical Devices

Published Date: 27 Sep 2017

FDA Jurisdiction over Medical Devices:

This includes Product Development – Design Controls, Manufacturing, Clinical Trials, Regulatory Submissions and Post-market surveillance

Product Development – Design Controls:

“Design controls are an interrelated set of practices and procedures that are incorporated into the design and development process i.e., a system of checks and balances.”("Design Control Guidance For Medical Device Manufacturers ", 2014) These design controls are very effective to establish a well-defined process, diagnose problems and rectify them and to determine the needs of consumers.("Product development lifecycle: Medical device design and development," 2012) There are six unique phases of design control such as:

• Design Requirements
• Design Verification
• Design Validation
• Design Changes
• Design Transfer
• Design History File

Design Requirements:

It mainly includes the materials and other resources required for the design development. They are to be properly selected. This is necessary in the development process to ensure a consistent final product.

Design Review:

Design review identifies various deficiencies associated at different developmental studies. They are performed from prototype development to final design considering prototype analysis; production processes and gathering feedback for better product development. ("Product development lifecycle: Medical device design and development," 2012)

Design verification:

It is one of the critical stages in product development. It compares design output that meets the specifications defined in the design development.("Design Control Guidance For Medical Device Manufacturers ", 2014)

Design validation:

It is carried at specific operating conditions. It assures that the devices meet the specified use. It includes software validation and risk analysis.("Design Control Guidance For Medical Device Manufacturers ", 2014)

Design changes:

It emphasis on properly identifying the changes, documentation and validation of changes, and they have to be thoroughly checked and assessed before approval and implementation. ("Product development lifecycle: Medical device design and development," 2012)

Design transfer:

It assures that medical device design is properly converted into required specifications.("Product development lifecycle: Medical device design and development," 2012)

Design history file:

A device history file is maintained for every device. It comprises of the required documents that are used to illustrate that the design is carried out in accordance to the specified plans. ("Design Control Guidance For Medical Device Manufacturers ", 2014)

Regulatory Submissions:

The two types of regulatory submissions include

510(k):

Any device under Class I, II or III intended for marketing in United States requires the submission of 510(k)to FDA. 510(k) is based on substantial equivalence. Thus, prior to device marketing manufacturer must receive a letter from FDA describing that device is substantially equivalent and can be marketed.("Premarket Notification (510k)," 2014)

510(k) is an initial submission to FDA to illustrate that the device is substantially equivalent (safe and effective) to an approved medical device. ("Premarket Notification (510k)," 2014)

A device is substantially equivalent if it has the same

• Uses and characteristics of an already approved device.("Premarket Notification (510k),"2014) or
• Uses as an approved device, and has different characteristics and the information submitted to FDA as mentioned below.
  • Does not have any issues regarding safety and effectiveness.
  • That the device is as safe and effective as an already approved device.("Premarket Notification (510k)," 2014)

The below mentioned individuals are required to submit 510(k):

• Manufacturers who introduce their medical device product into the market
• Persons authorized in making changes in labels
• Foreign manufacturers who introduce their product
• Specification developers.("Premarket Notification (510k)," 2014)

Premarket Approval: It is the evaluation of Class III devices by FDA to determine safety and effectiveness. Class III devices are high risk devices so it is difficult to evaluate their safety and effectiveness by normal measures alone so these devices require premarket approval before they are introduced into the market. ("Premarket Approval (PMA)

")

The most important criteria for premarket approval are good scientific writing and knowledge. The data provided in the technical section determines the approval of PMA application. Technical sections include Non-clinical laboratory studies and Clinical investigations.("Premarket Approval (PMA)

")

Non-clinical laboratory studies involve animal tests and other related studies. Clinical Investigations include safety data, study protocols, adverse reactions and other analysis data.("Premarket Approval (PMA)

")

Post-market surveillance: During the premarketing stage FDA takes all the required measures to ensure that they are minimal risks associated with the use of devices and also in the approval process. Hence, issues arise after marketing.("Device Postmarket Surveillance,")

Thus post-market surveillance is a process to oversee the safety and effectiveness of medical devices after marketing. This process is required to identify safety concerns related to the use of devices, to determine any malfunction devices and to develop alternatives for these problems.("Device Postmarket Surveillance,")

Bibliography:

Design Control Guidance For Medical Device Manufacturers (2014). Medical Devices. Retrieved 03, 2014, from http://www.fda.gov/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm070627.htm

Device Postmarket Surveillance. 04/24/2013). Retrieved 03/03, 2014, from http://www.fda.gov/MedicalDevices/Safety/CDRHPostmarketSurveillance/default.htm

Premarket Approval (PMA)

01/24/2012). Retrieved 03/03/2014, 2014, from http://www.fda.gov/Medicaldevices/Deviceregulationandguidance/Howtomarketyourdevice/Premarketsubmissions/Premarketapprovalpma/Default.Htm

Premarket Notification (510k). (2014, 01/03). Retrieved 03/03/2014, 2014, from http://www.fda.gov/medicaldevices/deviceregulationandguidance/howtomarketyourdevice/premarketsubmissions/premarketnotification510k/default.htm

Product development lifecycle: Medical device design and development. (2012). MaRS. Retrieved 03/03/2014, 2014, from http://www.marsdd.com/articles/medical-device-development-lifecycle/

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