Software as a Medical Device (SaaMD) Certification

February 9, 2022

FDA is tasked with ensuring the safety and effectiveness of many medical products. The agency largely regulates software based on its intended use and the level of risk to patients if it is inaccurate. If the software is intended to treat, diagnose, cure, mitigate, or prevent disease or other conditions, FDA considers it a medical device. As with any medical device, AI-enabled software is subject to FDA review based on its risk classification.

FDA REVIEW

Class I devices, such as software that solely displays readings from a continuous glucose monitor, pose the lowest risk. Class II devices are considered to be moderate to high risk. Most Class II devices undergo a 510(k) review in which a manufacturer demonstrates that its device is “substantially equivalent” to an existing device on the market with the same intended use and technological characteristics. It typically takes nearly 5 months to get 510(k) clearance from submission to decision. The FDA 510(k) costs include an FDA 510(k) Device Review User Fee of $3,186 and FDA Annual Establishment Registration Fee of $5,672

Alternatively, some Class I and Class II device manufacturers may need to submit a De Novo request to FDA, which is used for devices that aren’t substantially equivalent to an existing product but whose safety and underlying technology are well understood, and which are therefore considered to be lower risk. The De Novo Classification Request fee is $28,114 plus the FDA Annual Establishment Registration Fee of $5,672.

Something to consider - FDA 510K manufacturers can spend in the range of $20,000-$30,000 to have their product or device prepared and reviewed by an external firm before the actual FDA 510k or De Novo submission process.

During the FDA approval process, SaaMD is classified into one of three distinct groups based on patient risk: Class I (low risk); Class II (moderate risk); and Class III (high risk).

FDA APPROVAL TYPES REQUIRED

General Controls – Class I, II, III

These are the first level of controls, with the least amount of regulatory control whenever the level of device risk is low. Examples of general controls include: adulteration or misbranding, device electronic establishment registration and listing, premarket notification, quality systems, medical device reporting, and labeling. Class I, Class II and III need to meet this control.

Special Controls – Class II, III

This is the second level of controls, applicable when general controls alone are insufficient to assure safety and effectiveness. Examples of special controls include: device guidelines & manuals, adhering to a mandatory performance standard, recommendations or other actions, and special labeling. Class II and III must meet this control.

Premarket Notification – Class II, III

Premarket notification, also known as 510(k) notification is mandatory registration for manufacturers to notify FDA (Food and Drug Administration) about their intent to market a medical device. It is mandatory to prove to FDA that a medical device is subsequently equivalent to a device already available in the market. 510(k) notification is to demonstrate that the medical device is as safe and effective as other equivalent devices legally available in the market, and that is not subject to premarket approval. Until the applicant receives an order that declares the device as safe and effective, the applicant must not market the device.

Alternatively, some Class II device manufacturers may need to submit a De Novo request to FDA, which is used for devices that are novel but whose safety and underlying technology are well understood (general and special controls provide a “reasonable assurance” of the device's safety and effectiveness), and which are therefore considered to be lower risk.

Premarket Approval (PMA) - Class III devices

If a manufacturer wishes to market a new kind of Class III device, which is not available in market (as of 1976) or having a different material or different design than previously available devices, to ensure the primary safeguard of user, manufacturer must submit a premarket approval application to the FDA for review. Examples of PMA controls include: clinical investigations, safety and effectiveness data, adverse reactions and complications, patient information, and many more according to the type of device.

ADDITIONAL INFORMATION

The eSTAR is an interactive PDF form that guides submitters through the process of preparing a comprehensive medical device submission. The eSTAR is free and available for voluntary use for all medical device submitters for 510(k)s and De Novos submitted to CDRH. Use this link: https://www.fda.gov/medical-devices/how-study-and-market-your-device/voluntary-estar-program#contact

WHO CAN YOU CONTACT?

Contact the Division of Industry and Consumer Education (DICE) by email at DICE@fda.hhs.gov, or by phone at (800) 638-2041, or (301) 796-7100, if you have questions or feedback regarding the use of the eSTAR, or if you have general questions about medical devices.

If you have questions regarding 510(k)s or De Novos, please contact OPEQSubmissionSupport@fda.hhs.gov.