You must follow the steps below prior to marketing a medical device in the United States:Step One: Classify Your Device
Step Two: Choose the Correct Premarket Submission
Step Three: Prepare the Appropriate Information for your Premarket Submission to the FDA
Step Four: Send your Premarket Submission to the FDA and Interact with FDA Staff during Review
Step Five: Complete the Establishment Registration and Device ListingMedical devices are categorized into one of three classes, based on the degree of risk they present. These classes are as follows:
Class I – Lowest Risk, Class I devices are subject to general controls.
Class II – Moderate Risk, Class II devices are subject to general controls and special controls.
Class III – Highest Risk, Class III devices are subject to general controls and premarket approval.
After the device classification, you then select the premarket submission required for that regulation. The most common types of premarket submissions include:510(k) (Premarket Notification)
Some Class I and most Class II devices require a 510(k). In a 510(k), the sponsor must demonstrate that the new device is “substantially equivalent” to a predicate device in terms of intended use, technological characteristics, and performance testing, as needed. Some Class I and Class II devices are exempt from 510(k) if they do not exceed the limitations of exemption stated in 21 CFR xxx.9, where xxx refers to 21CFR 862-892.PMA (Premarket Approval)
Most Class III devices require a PMA. A PMA is the most stringent type of premarket submission. Before the FDA approves a PMA, the sponsor must provide valid scientific evidence demonstrating reasonable assurance of safety and effectiveness for the device’s intended use.De Novo (Evaluation of Automatic Class III Designation)HDE (Humanitarian Device Exemption)
JK Consulting Services:
• Establishment Registration and Listing
• Medical Device Labeling
• Premarket Notification (510K)
• Premarket Approval (PMA)
• US Agent and etc.