FDA Software Regulations

The U.S. Food and Drug Administration has established regulations for the production and use of software as a medical device and software used to design, manufacture or develop other medical devices. They define a device as an instrument or accessory used for the diagnosis or treatment of diseases or one that is intended to affect the functions of the body.

Applicability

• According to the document "General Principles for Software Validation" created by the FDA, regulations can be applicable to all types of software since they follow generally recognized software validation principles, but they are specifically intended to cover any software used as a component, part or accessory of a medical device, software used in the production of a device, software that is itself a medical device and software used in the implementation of the device manufacturer's quality system.

Verification

• Verification is one of the regulations that software producers must meet in order to comply with law. Defined in "General Principles of Software Validation", verification provides evidence that, in a specific phase of the production, all the requirements were met. Verification proves the consistency, completeness and correctness of the software and its supporting documentation. Verification provides information for validation.

  Software Testing is one of the many activities that verify whether or not the software qualifies for a phase meet up to specifications. Other verifications might include various static and dynamic analyses, walkthroughs, code and document inspections, and other techniques.

Validation

• While verification is a continuing analysis of the production process, validation is an analysis of the end product. Without validation of your software, you cannot legally sell it.

  Validation consists, according to "General Principles of Software Validation," of seeing that the specifications for the consumer's needs and uses and the requirements of the software design were met. Validation makes sure that all requirements of design are being accomplished. To establish correct and complete implementations, inspection methods can include comprehensive software testing, analyses, and other tasks performed at each phase of the software's development.

Design and Development

• For development, requirements include the identification of the software, documentation of information about the software and its uses, possible hazards and user characteristics. These requirements define the use of the software and include a document with a written definition of the software functions. Reviewers must find any possible sources of software failure and analyze and identify the measures necessary to prevent it.

  In "General Principles of Software Validation" the FDA states that the requirements for design of a software should include a description of what the software should do and how it functions, both as summary and as a detailed description.

General Principles

• The user of the software must also follow certain regulations, the most important of all being to properly utilize documentation explaining software use.

  Other FDA regulations can have a very broad scope, and abiding by them can be very time-consuming, but following them is necessary in order to prevent any future harm. To obtain a complete description of FDA regulations, you can find their publication named "General Principles of Software Validation" on their website.