FDA Validation of Medical Devices with National Instruments Hardware and Software - FAQ
Print
Overview
Medical device development can be a slippery slope to climb. Even in the best cases when you are dealing with proven treatments, two fundamental and opposing pressures drive the development process. On one hand, quality is the highest concern because failure can often lead to patient injury and costly product recalls. On the other, reducing development time is equally critical to establishing an early position in a very competitive market. To manage the quality concerns, agencies such as the Food and Drug Administration (FDA) have been established to help guide and enforce best practices for the development of safe and reliable devices. The rest is up to you, the engineer, to work within those constraints and meet all of the requirements in the most timely and cost-effective manner.
Table of Contents
The first step in the development of software that will be used in conjunction with a medical device is to understand the regulations. In the end, the FDA is concerned with one thing - the safety of the public. It is your job as the device maker to prove to the FDA that you have done your due diligence to ensure that the device that you have produced is as safe as it can be.
Key Terms
Medical Device - any apparatus for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals. These can be class I, II, or III.
Substantial Equivalence - A device that I has the same intended use as an existing device and has the same technological characteristics or does not raise new questions of safety and/or effectiveness.
510(k) submission – also known as Premarket Notification (PMA). Device manufacturers must register to notify FDA, at least 90 days in advance, of their intent to market a medical device must submit one of these.
Premarket Approval (PMA) – Devices that do not demonstrate substantial equivalence to another approved device must submit for premarket approval.
Important FDA Guidances
CFR21 Part820 – also known as a quality assurance (QA) process or good manufacturing practice (GMP), this guidance provides guidelines for design, development, test, and maintenance of a medical device.
CFR21 Part11 – is a regulation on the use of electronic signatures and retention of electronic records, validation of computer systems, data security, integrity, and confidentiality. The regulations impact the use of computer-based instrumentation in the area of I.D.s, passwords, and authorization of procedures in the lab.
FAQ
Do I need to validate my design?
If your design falls under the FDA’s definition of a medical device, then it is subject to FDA regulations.
Do I need to validate my test system?
Any test system that is used in the manufacturing and/or verification of a medical device must also be included in the validation process of that device. This means that the test code is subject to the same scrutiny with regards to development practices, change management, and documentation as the firmware of the device.
Is National Instruments hardware/software FDA validated?
National Instruments provides tools for engineers, not end devices. Therefore, it is the responsibility of the user to validate his/her use of the tools. There are many examples of FDA validated applications built with LabVIEW and other NI hardware and software components. The FDA provides guidance on use of off-the-shelf technologies in medical devices, and these can be found in the FDA guidance on Off-The-Shelf Software Use in Medical Devices.
Is National Instruments ISO 9001 certified?
National Instruments is an ISO 9001-certified company. It uses a Quality Management System framework to define, communicate, measure, and improve all key company processes to deliver high-quality, reliable products to NI customers. NI uses a defined process, the New Product Introduction process, to take a product from concept to delivery, specifying the required steps that are followed in research, design, development, quality assurance, marketing, manufacturing, sales, and support. The company formally tracks this process in an online Oracle-based system. NI stores documents and source code in revision control systems and uses databases for all testing and issues tracking. This paper provides detailed information about the NI software engineering process for product development.
Where can I find more information about developing CFR21 Part820 compliant applications with LabVIEW?
Read the following document - How LabVIEW Code Can Be FDA Validated: Complying with current Good Manufacturing Practice (GMP/cGMP)
Where can I find more information about developing CFR21 Part11 compliant applications with LabVIEW?
The following application note discussed using LabVIEW to create CFR21 Part11 compliant applications.
Where can I find help validating my design?
The NI Alliance Program contains many integrators with extensive experience in achieving validation with NI products.
Next Steps
Apply for the Medical Device Grant Program
Read White Papers, Case Studies
Print
Reader Comments | Submit a comment »
Legal
This tutorial (this "tutorial") was developed by National Instruments ("NI"). Although technical support of this tutorial may be made available by National Instruments, the content in this tutorial may not be completely tested and verified, and NI does not guarantee its quality in any way or that NI will continue to support this content with each new revision of related products and drivers. THIS TUTORIAL IS PROVIDED "AS IS" WITHOUT WARRANTY OF ANY KIND AND SUBJECT TO CERTAIN RESTRICTIONS AS MORE SPECIFICALLY SET FORTH IN NI.COM'S TERMS OF USE (http://ni.com/legal/termsofuse/unitedstates/us/).