The process of bringing a new medical device to the market involves thorough evaluation and regulatory approval to ensure patient safety and efficacy. One common pathway for obtaining clearance from the U.S. Food and Drug Administration (FDA) is through the 510(k) submission process.
Quality Smart Solutions offers medical device compliance solutions to ensure your device complies with the applicable FDA medical device regulations so that your business can cater to the USA marketplace. seeking guidance from our regulatory experts can greatly enhance your chances of preparing a successful 510(k) submission, ensuring that your innovative medical device reaches the market while adhering to the highest standards of safety and efficacy. As of October 1st all 510(k) submissions must be done through the online eSTAR portal. Click here to read our article outlining it’s benefits, important tips, the review process and how to submit your application with eSTAR.
Quality Smart Solutions offers end-to-end compliance assistance in product classification, regulatory strategic planning, submission approval process, interaction with regulatory agencies during development stages, and preparation of fulsome application dossiers (including a detailed list of documents, reports, diagrams, or clinical data that are required for medical device registration).
Former FDA specialists will review testing requirements, check relevant FDA guidance documents, ensure you meet required standards to have your medical device registered.
Avail support in getting the FDA’s Unified Registration and Listing System (FURLS)/ Device Registration and Listing Module (DRLM), thereby getting your facility registered.
Leverage our expertise in submitting your application for In Vitro Diagnostics (IVD) or filing a Premarket Notification with the FDA, also known as an FDA 510(k). Call for step-by-step guidance.
Register your SaMD with FDA with the help of our software device licence experts. We will assist you in the process based on risk evaluation, inclusion and exclusion.
Domestic and foreign manufacturers, distributors, or importers of medical devices in the USA must register their establishment with the FDA.
Your establishment license will be suspended if you fail to comply with regulations or present misleading statements in the application.
Every medical device manufacturing facility undergoes FDA inspection to ensure compliance with quality standards.
Medical devices include a wide range of medical or health instruments that are used for treating, mitigating, diagnosing, or preventing diseases or abnormal health conditions. These devices can be hip implants, pacemakers, artificial heart valves, syringes, thermometers, contraceptive devices, and medical laboratory diagnostic instruments.
Medical devices are classified into Class I, II, and III in the USA. While most of the Class I devices are exempt from Premarket Notification 510(k), most of the Class II devices need Premarket Notification 510(k). Class III devices require Premarket Approval. All classes of medical devices in the USA need to be manufactured and approved under FDA regulations.
We have licensed a wide range of Medical Devices, including but not limited to below
Identify Predicate Device: Begin by identifying a predicate device that is already on the market and similar to your medical device. The comparison between your device and the predicate device forms the basis of demonstrating substantial equivalence.
Classify Your Device: Determine the correct classification of your device under FDA regulations. Classifying your device helps establish the regulatory pathway and the specific requirements for your submission.
Prepare the 510(k) Submission: The submission should include detailed information about your device, its intended use, technical specifications, and performance data. This comprehensive documentation supports the assertion of substantial equivalence.
Risk Analysis: Conduct a thorough risk analysis of your device, identifying potential hazards and mitigations. This analysis demonstrates your understanding of potential risks and your commitment to patient safety.
Performance Testing: Provide data from performance testing that supports the safety and effectiveness of your device. Bench tests, animal studies, and clinical data may be necessary depending on the device’s complexity.
Prepare a Summary: Craft a concise and clear summary that outlines the similarities and differences between your device and the predicate device. This summary is crucial for FDA reviewers to understand your substantial equivalence argument.
The 510(k) submission is named after the section of the Federal Food, Drug, and Cosmetic Act where it is found. It serves as a premarket submission to the FDA, demonstrating that a new medical device is substantially equivalent to a legally marketed device (predicate device) that does not require premarket approval (PMA).
A medical device is any instrument, apparatus, implement, machine, or contrivance, including any component part or accessory which is:
● intended by the manufacturer to be used for human beings for one or more of the following purposes:
● diagnosis;
● therapy;
● surgery; or
● prevention of disease which does not achieve its principal intended action in or on the human body by pharmacological, immunological, or metabolic means.
Owners or operators of establishments that are involved in the production and distribution of medical devices intended for use in the U.S. are required to register annually with the FDA.
Unless they are class I medical devices the following products will need to be licensed by the FDA:
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