We provide comprehensive and high-quality Documentation, coupled with technical guidance, for both traditional and abbreviated FDA 510k submissions.
Acting as US FDA agents, we handle establishment registrations and correspondence on behalf of our clients.
We assist with Medical Device Establishment Registration and Listing for Class 1 and 510k cleared devices.
FDA 510k Certification for Medical Device an FDA 510k file contains crucial information demonstrating that a medical device is as safe and effective as legally marketed devices not subject to PMA. If pre-market approval is not required, organizations planning to introduce Class I, II, and III medical devices for human use in the US must submit a 510k.
While most class 1 medical devices are exempt from 510k requirements, if the FDA determines a device to be substantially equivalent during the review process, it will grant the 510k medical device clearance with a ‘(k)’ number. As experienced 510k consultants, we offer technical and scientific assistance in identifying suitable predicate devices, regulation numbers, and device codes. We also support 510k drafting, e-copy conversion, FDA submission, and Q-Submission for selected manufacturers.
With an 85% success rate, over 180 510k clearances, and serving 112+ manufacturers since 1999, we are well known as one of the best and largest regulatory compliance solution providers for medical device US FDA 510k pre-market notifications, offering cost-effective services.
Registration and Listing Search Easily search for predictive device manufacturers, registrations, and device listings through the FDA database.
Device Classification Database Search Identify the device code and regulation number to make informed decisions regarding 510(k) submissions.
FDA Establishment Registration For most Class 1 device manufacturers, market entry in the USA becomes possible after FDA registration and listing.
US FDA 510k Submission Process Understand the roles of consultants and 510(k) applicants in the FDA 510k submission process.
Make informed decisions and expedite your path to success.
Traditional 510k This original submission is typically required for medical devices requiring FDA clearance, according to 21 CFR 807. It can also be used for submissions involving changes to previously cleared devices. The traditional 510k submission process generally takes 90 days.
Appropriate when FDA guidance exists for specific medical devices, and compliance can be demonstrated through voluntary FDA-recognized consensus standards. This submission type includes a brief report on the usage of FDA guidance documents, adherence to FDA-approved standards, and supporting data.
This submission is intended for modifications to an already cleared device that does not require a full review but only the submission of a summary document. Changes may include indications of use, design, and labelling if they do not affect the safety or performance of the modified device and established evaluation.