Our FDA 510(k) Consultants got an extensive experience in all aspects of the regulatory processes of 510(k), Pre-Sub/Q-Sub, Pre-IDE,IDEs and PMA submissions. Medical devices are classified as Class I, Class II and Class III based on their risk profile. Most of the Class I medical devices are exempt from FDA 510(k) Clearance. Some of the Class I devices requires FDA clearance, all the class II and Class III devices require FDA clearance to market those medical devices in the US. The Class II devices should be cleared by the FDA through a 510(k) Premarket Notification (PMN), or De Novo submission process. The Class III devices require a IDE/Premarket Approval (PMA) submission to get the FDA’s approval to market the device in the US market. These medical devices should be in compliance withQuality System Regulations (QSR) are also known as current good manufacturing practices (CGMP’s) per ISO 13485. cGMP requirements for the medical devices per Section 21 Code of Federal Regulations (CFR) part 820 (21 CFR part 820) and the FDA expects that your Quality System shouldbe in compliance with 21 CFR Part 820, 803 and 807 and your product developed under Design Control 820.30.
510(k)/De Novo Submission:
The FDA requires that a 510(k) or a De Novo application (must be sent to the FDA in order tolegally market a medical device product in the U.S. The 510(k) must be submitted for certain Class I devices as well as for all Class II devices.
A new medical device requires a clinical study as a first step to determine whether your proposed clinical study of the device is deemed to be of “significant or nonsignificant” risk. If the study determined to pose a significant risk, an FDA Investigational Device Exemption (IDE) and Institutional Review Board (IRB) approval will be required before commencing the clinical study. If it’s determined to pose non-significant risk, only an IRB approval is required to proceed with the clinical study.The IDE is required to be approved by the FDA in order to collect safety and effectiveness data required to support a Premarket Approval (PMA) application, a Humanitarian Device Exemption (HDE), De Novo or a Premarket Notification [510(k) submission to the FDA. Clinical investigations in the United States must be approved by the FDA prior to conducting a clinical study on an investigational device on human subjects. The IDE rules are spelled out in 21 CFR Part 812.
What’s a “significant risk” in the eyes of the FDA? Here is an example, the implants and devices that sustain human life are obviously substantially risky but the FDA is less clear with regard to all other devices. Getting this determination right the first time is critical to prevent unnecessary delays when initiating a significant risk clinical study.
The FDA can reject your IDE application for many reasons. Some are obvious and preventable such as missing or inaccurate information. Other reasons that include inadequate reporting of prior investigations, poorly conceived investigational plans or incomplete design and manufacturing description. Our FDA consultants are experienced in helping you to navigate these challenges. We can help you to minimize the risk of rejection by crafting a regulatory strategy for your IDE application so that the FDA is less likely to rule that your device risks outweigh its benefits, it is perceived to be ineffective, or your proposed investigation is scientifically unsound.
The PMA (Premarket Approval) application must be submitted to the FDA in order to legally market a high risk or Class III medical device in the U.S. The PMA is required for certain Class II devices, where no substantially equivalent medical device currently exists in the market or previously cleared by the FDA, and high risk Class III devices that are not yet approved by the FDA.Our FDA consultants are experienced in helping you to navigate these challenges.
Master Files for devices (MAFs) Submission:
The Master Files for devices (MAFs) also commonly called as Device master file (DMF) is a file that is submitted to the FDA that includes technical, clinical, and safety information about a medical device component or a material. If you are a material or component maker, your customers may request or desire a MAF/DMF from youin order to fulfil the regulatory requirement before they start using your material for manufacturing a medical device.Our FDA consultants are experienced in helping you to navigate these challenges.
Please contact us for all your FDA related regulatory or compliance needs. We will be able to work with you and help you with your FDA product approval.
Copyright © 2021 FDA CONSULTING LLC.