FDA 510(k) Consultant services in which we classify the devices & gathers information about the company products which are then uploaded through an online process. For class II devices, there is a process called the US FDA 510(k) process or the pre-market clearance. In this, the safety & effectiveness of the device is established through substantial equivalence.
FDA 510(k) is required for:
Domestic manufacturers introducing a device to the U.S. market. Re-packers or Re-labellers who make labelling changes or whose operations significantly affect the device.
A device is considered identical only if, in comparison to a predicate it:
- The device has to have the same intended use as the predicate; and
- Also, the device should have the same technological characteristics as the predicate;
- The device has the same deliberate use as the predicate; and
- Whether the device has different technological characteristics and does not raise different questions of safety and effectiveness; and
- The data submitted to FDA reveals that the device is at least as safe and effective as the legally marketed device.
The state of considerable equivalence does not mean the new and predicate devices must be identical. Significant equivalence is established with respect to intended use, design, energy used or delivered, materials, chemical composition, manufacturing process, performance, safety, effectiveness, labeling, biocompatibility, standards and other characteristics, as applicable.
Foreign manufacturers/exporters or U.S. representatives of foreign manufacturers/exporters introducing a device to the U.S. market.
FDA 510(k) is required when:
Anyone who wants to sell a device in the U.S. It is required to make the US FDA 510(k) submission at least 90 days prior to offering the device for sale, even though it may have been under development or clinical investigation before that date.
Change in the intended use of a device which you already have in commercial distribution.
If there is a change or modification of a legally marketed device and that change could significantly affect its safety or effectiveness.
What is 510(k)?
Every device manufacturer who wants to trade in the U.S market its classified medical device Class I, II, and III device which is meant for human use, for this a premarket approval application (PMA) is not necessary, but must submit a 510(k) to FDA unless the device is exempt from 510(k) necessity of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) and does not overreach the circumstance of exemptions in .9 of the device classification regulation chapters (e.g., 21 CFR 862.9, 21 CFR 864.9).
The process 510(k) is a premarket approval made for FDA to signify that the device to be marketed is at least as safe and effective, that is, substantially equivalent, to a lawfully marketed device (21 CFR 807.92) that is not subject to premarket approval. The appliers must measure their medical device to one or more similar legally marketed devices to support their substantial equivalency claims.
And also note that FDA does not execute 510(k) pre-clearance facility inspections. The appliers may market their device immediately after 510(k) clearance is permitted. The manufacturer should be prepared for an FDA QSR (21 CFR 820) inspection at any time after 510(k) clearance.
The FDA does not “approve” FDA 510(k) submissions. It “clears” them. It is not legal to advertise a 510(k) cleared device as “FDA-approved.
A new US FDA 510(k) submission is required for changes or modifications to an existing device, where the modifications could significantly affect the safety or effectiveness of the device or the device is to be marketed for a new or different indication for use.
The medical device manufacturer which makes the products GMP non exempted are expected to implement the 21 CFR Part 820 as a quality management system. The products which are marked as GMP Non-exempted, the quality management system as per 21 CFR Part 820.
The US FDA 510(k) submission shall be prepared an submitted along with the review fees. The US FDA 510(k) review fees can be remarkably reduced based on the turnover. The entities including its affiliates shall have less than 100 million dollars turnover to be qualified as SBU(Small Business Unit). The review is conducted by CDRH(Center for Devices and Radiological Health) and raise queries if any. After successful completion of the activity, the US FDA 510(k) number is approved. After US FDA 510(k) approval, the Establishment registration and device listing shall be done in order to supply products in the US.
Operon Strategist is FDA 510(k) consultant helps the clients to register SBU(Small Business Unit), if applicable. Take out the testing requirement of product, creation of the dossier, resolving the queries and after completion of all the activities, the client receives the US FDA 510(k) approval. We also assist with the establishment registration and device listings to make suitable the supply of medical devices in the US.