For over 20 years, Empirical Technologies has been providing valuable expertise into various aspects of regulatory compliance, which includes hundreds of 510(k) submissions and clearances. With a long-standing relationship with the FDA and an impeccable track record of success in submission clearance, we’re proud to assist clients as they navigate the 510(k) submission process.
Manufacturers, contract manufacturers, contract sterilizers, repackagers and relabelers, specification developers, reprocessors of single-use devices, remanufacturers, manufacturers of accessories and components sold directly to the end user, and U.S. manufacturers of “export only” devices all must list their devices in their FDA registrations.
According to US regulations, these medical devices cannot be commercially distributed until the FDA reviews the 510(k) submission for the subject device and provides a letter of substantial equivalence. Requirements vary depending on the Class and regulation type of the device. Premarket Approval devices fall under Class III, which means they pose a significant risk of injury or illness.
For medical devices that require clinical data and a PMA review, or for medical devices that fall within the 510(k) but still require clinical data investigational devices, which are devices permitted for use in a clinical study by the FDA to obtain data on the safety and effectiveness of the device but are not yet fully reviewed by the FDA and not yet cleared or approved to market in the US, such devices must have an approved IDE before the study starts. Only studies approved by the FDA and an Institutional Review Board (IRB) can take place.
Facilities designing, purchasing, manufacturing, packaging, labeling, storing, installing, and servicing medical devices require compliance with US Quality System Regulations and are subject to FDA inspections to ensure operation and control according to the quality management system.
Certain information must be prominently displayed on medical devices on both the container and its box/wrapper along with other written, printed, or graphic matter.
Anytime a device may have caused death or serious injury, it must be reported to the FDA under the Medical Device Reporting program. The MDR helps the FDA and manufacturers identify and monitor events using medical devices in order to detect and correct problems promptly.
Devices in Class I pose the least threat of all the levels to both the patient and the user.
Without exemptions – The remaining 26% will need a premarket notification.
After the FDA verifies that the sponsor of the submission paid their submission and sends the Acknowledgement Letter of the submission’s receipt, the submission is sent to the appropriate Review Panel. Management from the Review Panel will assign a lead reviewer for the submission review. That lead reviewer then begins with the Administrative Review to determine if the content in the submission is sufficient for the FDA to conduct a substantive (or exhaustive) review.
Special 510(k) requests apply to sponsors who already own a legally marketed device, but want to modify it, change the intended use, or change the labeling. The modified device needs to produce substantial equivalence (SE) to its predecessor based on reliable data, and validation reports must be provided in a summary or risk analysis format.
The FDA will look at design control procedures to evaluate if the change(s) are well established and if they can be sufficiently reviewed. They intend to finish the whole process in 30 days compared to the typical 90 days for traditional 510(k)s.
– Intended use is the purpose of a device listed on the label
– Indications for use are the specific conditions the device treats, mitigates, or diagnosis and conditions for which the device may be used
Complying with FDA Regulations and submission requirements gets your device to market. If steps get skipped or left undone, the FDA will place holds on the submission reviews and clearance decisions until they are met or until the FDA cancels the submission because 180 days have lapsed since issuing the hold. These issues significantly delay manufacturers from marking their medical devices. Selling a regulated medical device without FDA clearance or approval may lead to legal ramifications.
Include the following components in your request:
Once in substantive review, the FDA will determine if any predicate devices exist to ensure the product meets De Novo requirements. If they need any additional information, they’ll send out an Additional Information Letter that needs to be completed within 180 days.
Empirical Technologies’ trusted FDA regulatory consultants will talk with you to gather the needed information and address any missing pieces of your submission ahead of time. Contact us to schedule a consultation today!