The PMN route and the 510(k) submission
Class II devices are devices which might potentially pose risk to the patient, but the technology used is not novel, and is well established in the professional community. Most medical devices reviewed by the FDA are Class II devices. These products are approved according to the Pre-Market Notification route, following the submission of a 510(k) file. However it must be noted that a few
class II devices are 510(k) exempt, and can be approved through a process similar to that of a class I device.
Your product is eligible to be submitted as a 510(k) file if three conditions are met:
- The use of your product poses potential risk to either the user or the patient.
- The technology employed in the product is not novel, and is well established in the medical community.
- Your product can be shown to be substantially equivalent (SE) to another product, already approved by the FDA.
Substantial equivalence has to be carefully demonstrated. First, you need to identify a product with similar technological and clinical features, which is substantially equivalent to your product. Such device is termed
"predicate device". To show that the device you intend to sell is as safe (or safer), and as effective (or more effective), than the predicate device, you might need to perform tests, be it bench, pre-clinical (animal), and (when applicable) you might need to perform
clinical trials on patients.
It should be stressed that the reviewing process is very critical. Although the FDA is obliged to respond within 90 days following the submission, in many instances the review process is unduly prolonged due to improper performance of the tests, erroneous statistical analysis, or other failures to comply with the agencys requirements. These failures are avoidable! Direct contact with the FDA and high level expertise will assure a fast approval process.
Other actions that need to be taken are:
- Contract with a US Regulatory Designated Agent in the USA.
- Register the manufacturer through the Regulatory Designated Agent with the FDA
- List the products through the Regulatory Designated Agent with the FDA.
The Regulatory Designated Agent
Companies that import medical devices into the United States need to appoint a
Regulatory Designated Agent. The Food and Drug Administration Modernization Act of 1997 (FDAMA) requires that "any establishment within any foreign country engaged in the manufacture, preparation, propagation, compounding, or processing of a
device that is imported into the United States shall register with [FDA] the name and place of business of the establishment and the name of the United States agent for the establishment". The role of a
U.S. Regulatory Designated Agent under the regulations requires that it be authorized to speak with FDA on behalf of the company, and to discuss proprietary information about the company.
For more information on the
Regulatory Designated Agent please go to the
Medes USA Inc. website.
Quality System Requirements
You will need to establish and maintain a Medical Quality Management System, compliant with the cGMP/QSR requirements, as described in 21 CFR Part 820.
For more information on the QSR go to the
FDA QMS Requirements section
