Software As a Medical Device

Software as a Medical Device: Software designed to be used for one or more medical functions that accomplish these functions independently of a physical medical device. The International Medical Device Regulators Forum (IMDRF) and US FDA establish a common and converged understanding of SaMD to demonstrate the safety, effectiveness, and performance of SaMD.

Software can be qualified as medical device based on the intended use and considerations listed in the FDA website.  Once the device is confirmed as software as medical device it is necessary to select the appropriate regulatory pathway with least burdensome approach based on identified product code from intended use. Identification of product code is a critical element in the Premarket submission. Among the different types of premarket submission, present the steps and the process involved in Traditional 510 (k) for SaMD is discussed in the flowchart depicted above.

Key factors to be considered for Traditional 510(k) of SaMD are:

• Substantial equivalence of the subject device with predicate device.
• Appropriate guidance and standards to be followed.
• Determination of Level of Concern of the SaMD.
• Compiling of details and documents for submission based on level of concern.
• Preparation of 510(k) sections as per FDA guidelines.
• Verification of RTN checklist.

Preparation of 510(k) sections is an important step in the process of documentation for Traditional 510(k) submission. The sections interrelated to each other in case of SaMD are:

• Indications for Use Statement (FDA Form-3881)
• 510(k) Summary
• Executive Summary
• Device Description
• Substantial equivalence
• Proposed Labeling

The sections mostly (not mandatory) include “not applicable” statement in case of SaMD are:

• Class III Summary and Certification
• Financial Certification or Disclosure statement
• Sterilization and Shelf life
• Biocompatibility Testing
• Electromagnetic Compatibility and electrical safety
• Performance Testing- Bench
• Performance Testing- Animal

The general administrative sections common for all Traditional 510(k) are:

• Medical Device User Fee Cover Sheet (FDA Form 3601)
• CDRH Premarket Review Submission Cover Sheet (FDA Form 3514)
• 510(k) Cover Letter
• Truthful and Accuracy Statement
• Declarations of Conformity to Recognized Standards

Guidelines for the Content of Premarket Submissions for Medical Device Software predominantly depends on the determination of level of concern (LOC). The minor LOC require only Risk management file (RMF), Software Requirement Specifications (SRS), Traceability analysis, verification and validation and Revision level history. In case of Moderate and major level of concern along with the listed documents in the minor level of concern additional documents i.e., Software Design Specifications (SDS), Architecture design chart, software development environment description also essential for 510(k) submission.

The Provision of software lifecycle process may not be mandatory, but it makes submission much easier. Compliance with IEC 62304 standard specifies the life cycle necessities may be recommended for 510(K) submissions in concern to moderate and major level of concern of the SaMD. In addition to mentioned documents list based on Level of concern in the flowchart the other documents related to cybersecurity, software certification, device specific compliance documents like DICOM, HIPAA, HL7etc., shall be documented depending on intended use of SaMD. Thus, Traditional 510(k) for software as medical devices is one of the simplified process of regulatory submission to save time and provide information up front.

For those seeking to outsource FDA 510k paperwork for SaMD, get in touch with I3CGlobal.

Mrs. Amrutha Rai  is the author of this informative article. She is a post graduate in pharmacy with experience in multiple type of device 510k’s.