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FDA 510k for Medical Device with Software

Software as a Medical Device (SaMD)

Software as a Medical Device” (FDA SaMD) refers to standalone software intended for medical purposes only, and not integrated with another device of primary use. SaMD is made usually to manage patient data, aid in decision making or support clinical decision-making. These software applications can range from simple mobile health apps to complex algorithms for diagnosing diseases or managing treatment plans.


FDA SaMD is subject to regulatory oversight by FDA in the United States, MHRA in the United Kingdom or the European Commission (EC) in the European Union. Depending on the risk classification and intended use, SaMD requires regulatory clearance or certificates before it can be marketed and used in clinical practice.

FDA 510k for Medical Device with Software

Securing FDA 510k clearance or premarket approval (PMA) for a medical device is a complex and stressful undertaking. The 510(k) process is a submission made to the FDA to demonstrate that a medical device is substantially equivalent to a device that is already legally marketed for the same use.


Overall, 510(k) consultants play a crucial role in helping SAMD manufacturers navigate the regulatory requirements associated with bringing their software products to market, ensuring both compliance and patient safety.

Types of Software Device

Software as a Medical Device (SaMD) encompasses a wide range of software applications used in healthcare for diagnostic, therapeutic, or monitoring purposes. These software devices vary in complexity and function. Here are some common types of software devices:


  • Clinical Information System (CIS)
  • Electronic Prescription (EP) System
  • Clinical Decision Support Systems (CDSS)
  • Radiology Information Systems (RIS)
  • Laboratory Information System (LIS)

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Software 510k - Role of Consultants

The role of a software 510(k) consultant is to guide software developers through the complete process streamline the 510(k) submission process, and ultimately help get 510k clearance faster.


  • Consultants help assess whether the software device in question is substantially equivalent to the predicate device. This involves technical debate with the developer team by comparing the intended use, technological characteristics, state-of-the-art, and performance data of the new device to those of the predicate device.
  • Consultants assist in preparing the 510(k) documentation file as per abbreviated or traditional way, which includes writeup on device description, indications for use, labelling, software documentation, risk analysis, software version controls, software testing and performance testing data. They ensure that the submission is comprehensive and meets FDA requirements.
  • 510(k) consultants provide recommendations for remediation to address identified gaps and ensure that the device meets applicable standards.
  • Consultants help software developers establish a robust risk management process for the software device, including identifying potential hazards (limited to general knowledge of consultants), assessing risks, implementing risk controls, and documenting risk management activities.
  • Consultants facilitate communication between the software developer and the FDA throughout the 510(k) review process if required. Consultants / US Agents interact with the FDA on behalf of the developer, respond to inquiries or requests for additional information, and update the 510k file.


Overall, the role of a software 510(k) consultant is essential for small and medium-sized developers to guide the regulatory maze, streamline the 510(k) submission process, and ultimately help bring safe and effective software devices to market in compliance with FDA regulations