What is Intended Use Validation?
Tips for complying with FDA regulations.
By Brent Noblitt, Senior Partner, Noblitt & Rueland
Manufacturers of medical devices sold in the United States must comply with FDA's requirement for intended use validation. Simply stated, device makers must confirm and document that a specific software application or system produces the results which were previously intended or specified.
What's included in the regulation?
In FDA's Quality System Regulation (21 CFR 820, Final Rule, Oct. 7, 1996) the agency states in 820.70(i) that:
"When computers or automated data processing systems are used as part of production or the quality system, the manufacturer shall validate computer software for its intended use according to an established protocol. All software changes shall be validated before approval and issuance. These validation activities and results shall be documented."
Intended use validation requirements apply to software used in production of the device or in implementation of the device manufacturer's quality system. This includes software used in computer-controlled manufacturing processes and electronic documentation/record keeping systems as well as software used for trending, complaint handling, automated testing, packaging, assembly, inspection, labeling, and sterilization. The software and systems involved can range from software controlling complex multiprocessor systems to simple spreadsheet applications. Software used in medical devices or software that is itself a medical device must comply with other requirements and guidance as set forth by FDA.
What's entailed in the actual testing?
Essentially, a black box test is performed by inputting defined ranges of data and then checking to ensure that the expected output is obtained within specified acceptable criteria. Although, not specifically stated in the regulation, the level of detail required when performing an intended use validation for a system or program should be commensurate with the complexity, risk, and resulting safety to the patient or user of the finished product. This can be determined and documented using risk analysis.
When performing an intended use validation, all activities should be documented. Keep in mind the phrase, "If it isn't written down, it didn't happen." Take credit for any validation activities by documenting them. Some intended use validations can be quite simple to perform by a knowledgeable person, while other intended use validations can require considerable expertise. In some cases, outside experts can be very helpful in assessing what is required for intended use validation and help get the process started.
How important is compliance?
Why should a company care if they have completed intended use validations on all of their software relevant to this regulation? Simply put, it's the law. FDA inspectors will inquire whether automated processes and software have been validated to their intended use. Deficiencies in this area are enforceable by FDA and may result in serious consequences if not remedied.
Performing intended use validation may also help protect against product liability litigation. In addition, intended use validation can avoid repetition of certain operations and prevent materials or products from being reworked or scrapped.
Device manufacturers should assess all of their operations, especially those in their manufacturing, production, quality, and regulatory departments, and list the operations and activities that involve the use of software. The next step is to determine whether intended use validations need to be performed and to what level.
Manufacturers should also get assistance from their vendors. Suppliers of software-controlled products such as documentation management systems and manufacturing systems should provide an intended use validation service during installation. And market-savvy vendors and suppliers of software used by medical device manufacturers should make available intended use validation as part of their product offering in order to meet the needs of their clients.
Brent Noblitt, Noblitt & Rueland, 5405 Alton Pkwy., Ste. A530, Irvine, CA 92604. Phone (714) 258-4646; Fax (714) 258-3990.