The FDA Approval Playbook for Class I & II Medical Devices

For many medical device innovators, the journey to market begins — and potentially ends — with obtaining FDA approval. While Class III devices face the tallest hurdles to approval, the process is still complex and time-consuming for Class I and II medical devices. The process grows even more complicated if a MedTech company lacks the necessary regulatory compliance expertise to efficiently navigate submissions and requirements, leaving an R&D-focused team alone to face the countless challenges on the road to approval.

Breaking Down the FDA Approval Process for Class I and II Devices

While the process may look slightly different for each device, the FDA approval roadmap generally follows six key steps:

1. Classify your device. Your device classification will determine the regulatory pathway you follow to obtain FDA approval. Class I devices, such as bandages and masks, are low-risk and thus require the least regulatory control.¹ Class II devices, including syringes and catheters, pose a higher risk to patient safety and require tighter regulation by the FDA.¹
2. Establish a Quality Management System (QMS). For both Class I and II devices, establishing a robust QMS is crucial for successful FDA approval and subsequent customer satisfaction. A QMS ensures that all aspects of production meet the required quality and consistency standards, from raw material sourcing and machining to packaging and sterilizing.² For Class II devices, compliance with ISO 13485 is often mandatory, adding another layer of regulatory complexity that follows the device through its entire lifecycle. 
3. Obtain premarket notification, if needed. While Class I devices generally do not require a 510(k) premarket notification, most Class II devices must obtain 510(k) clearance to demonstrate the device is substantially equivalent to another legally marketed device in terms of intended use, technological characteristics, and performance testing.³ While demonstrating equivalence is less cumbersome than providing proprietary clinical evidence, the process can still be costly and time-consuming. 
4. Document product design and development. Documenting every step of the production process is key to submitting an accurate and complete regulatory application. This includes design history files, risk management reports, and validation data. Your application must provide a clear connection between design inputs and outputs, demonstrating that the device meets end-user needs while adhering to stringent quality standards.
5. Ensure proper labeling and instructions for use (IFU). Every device must have proper labeling and a corresponding IFU document that includes the name and location of the manufacturer, the intended use, and directions for use, followed by precautions, warnings, and any other information necessary for safe and effective operation.⁴
6. Submit for regulatory review. Once you have compiled and verified the necessary documentation, including QMS documentation, design and development files, and labeling information, the next step is to submit your application to the FDA for approval. If all requirements are met and no additional documentation is needed, your device will be approved to go to market.

How Single-Source Manufacturing Streamlines and Simplifies FDA Approval

The road to FDA approval may be complex, but a single-source medical device manufacturing partner like Ranfac can make the journey simple and hassle-free. Ranfac’s vertically integrated facility leverages a cloud-based QMS to document every detail of production from start to finish, with an in-house regulatory team to analyze, compile, and submit for every regulatory clearance on behalf of our customers. While many companies wait three years or longer to bring their device to market, Ranfac’s single-source model accelerates FDA approval to reduce the wait time by half, if not more.⁵ With deep regulatory and medical device expertise, Ranfac stands apart as the premier medical device OEM and contract manufacturing partner, crafting compliant, high-quality custom medical device solutions that obtain FDA approval quickly for rapid market penetration. 

Want to learn more? Connect with our team to learn how Ranfac can help you get to market faster with in-house regulatory assistance.

Sources

1. Classify Your Medical Device. (2020, February 7). FDA. https://www.fda.gov/medical-devices/overview-device-regulation/classify-your-medical-device 
2. Quality System (QS) Regulation/Medical Device Current Good Manufacturing Practices (CGMP). (2024, January 31). FDA. https://www.fda.gov/medical-devices/postmarket-requirements-devices/quality-system-qs-regulationmedical-device-current-good-manufacturing-practices-cgmp 
3. Premarket Notification 510(k). (2023, December 5). FDA. https://www.fda.gov/medical-devices/premarket-submissions-selecting-and-preparing-correct-submission/premarket-notification-510k 
4. General Device Labeling Requirements. (2018, March 27). FDA. https://www.fda.gov/medical-devices/device-labeling/general-device-labeling-requirements 
5. Van Norman G. A. (2016). Drugs, Devices, and the FDA: Part 2: An Overview of Approval Processes: FDA Approval of Medical Devices. JACC. Basic to translational science, 1(4), 277–287.