In the United States, the USFDA regulates the sale of medical devices. There are different regulatory controls for devices of different classes. For class I devices & some 510(k) exempted devices, there is an establishment & registration & device listing.
Operon Strategist classifies 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 510(k) process or the pre-market clearance. In this, the safety & effectiveness of the device is established through substantial equivalence.
The 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.
Foreign manufacturers/exporters or U.S. representatives of foreign manufacturers/exporters introducing a device to the U.S. market.
A Manufacturer needs 510k when:
Anyone who wants to sell a device in the U.S. It is required to make the 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.
A new 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 FDA 510 k submission shall be prepared an submitted along with the review fees. The 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 510 (k) number is approved. After 510 (k ) approval, the Establishment registration and device listing shall be done in order to supply products in the US.
We help clients to register SBU, 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 510 (k) approval. We also assist with the establishment registration and device listings to make suitable the supply of medical devices in the US.