GUIDANCE AND STANDARDS

The Center for Devices and Radiological Health (CDRH) uses standards and guidance to control the development of medical devices. Some of the groups that CDRH relies on include the American National Standards Institute, the Institute of Electrical and Electronic Engineers, and Underwriters Laboratories. A database of standards used by the CDRH can be found here.

There are guidance documents prepared for FDA staff, regulated industry, and the public, focusing on the FDA’s interpretation of or policy on a regulated issue. Guidance documents include those that pertain to:

Software Validation

FDA guidance for medical device software can be found in the document titled General Principles of Software Validation; Final Guidance for Industry and FDA Staff. All software—from machine-tool embedded software, to materials-planning software, to simple spreadsheets, to the software controlling a medical device—is subject to these regulations. In cases where the software is developed by someone other than the device manufacturer (e.g., off-the-shelf software), the device manufacturer is responsible for compliance with FDA regulations, not the software developer.

The guidance document, Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices provides industry with information regarding the FDA-recommended documentation to be included with premarket submissions for software devices, including stand-alone software applications and hardware-based devices that incorporate software.

The Policy for Device Software Functions and Mobile Medical Applications Guidance, first issued in 2013 as "Mobile Medical Applications" (MMA guidance) and updated in 2015 and 2019, explains the agency's oversight of device software functions, including mobile apps that are medical devices and whose functionality could pose a risk to a patient’s safety if the mobile app were to not function as intended.

Quality Systems

Quality system regulations from the FDA include requirements related to the methods used in and the facilities and controls used for designing, purchasing, manufacturing, packaging, labeling, storing, installing, and servicing of medical devices. Manufacturing facilities undergo FDA inspections to assure compliance with the quality system requirements.

According to FDA guidance, “manufacturers of medical devices must establish and follow quality systems to help ensure that their products consistently meet applicable requirements and specifications. The quality systems for FDA-regulated products (food, drugs, biologics, and devices) are known as current good manufacturing practices (CGMP’s). Guidance on the CGMP requirements for devices can be found in the Code of Federal Regulations, 21 CFR part 820.[1]

Quality systems are regulated under the Code of Federal Regulations, 21 CFR 820 and the FDA guidance document, Medical Devices; Current Good Manufacturing Practice (CGMP) Final Rule; Quality System Regulation—as well as the Quality System Information for Certain Premarket Application Reviews.

Design controls are another factor to be considered with respect to FDA medical device regulation. Design controls are intended “to ensure that good quality assurance practices are used for the design of medical devices and that they are consistent with quality system requirements worldwide.”[2] The design controls discussed by the FDA in its guiding documents include: [3]

  • Design and Development Planning
  • Design Input
  • Design Output
  • Design Review
  • Design Verification
  • Design Validation
  • Design Transfer
  • Design Changes
  • Design History File.

Human Factors is another area that falls under FDA medical device quality system regulation. According to the FDA, “for medical devices, the most important goal of the human factors/usability engineering process is to minimize use-related hazards and risks and then confirm that these efforts were successful, and users can use the device safely and effectively.”[4]

Updated by Kevine Lidoro, November 2020