The medical device market is highly regulated to maintain safety for patients and the performance of devices. In the United States, the 510k Medical Device submission process is one of the significant regulatory avenues through which manufacturers sell their products. As a medical device manufacturer, it might be helpful to learn about the 510k process and how it applies to US FDA Certification in India if you plan to enter the U.S. market.
What is a 510k Medical Device?
A 510k Medical Device is one which has to be approved by the United States Food and Drug Administration (FDA) prior to its sale in the market. The 510(k) submission is a pre-market notification (PMN) procedure where companies have to prove that their device is “substantially equivalent” to a legally marketed device already on the market (so-called predicate device). This is to imply that the new device should have the same intended use, technological features, and safety features.
When Do You Require a 510k Submission?
You will require a 510k submission if:
- You are bringing in a new medical device that is substantially equivalent to a legally marketed device.
- You are significantly changing an already FDA-cleared device, like design changes, materials, or intended use.
- You are an international manufacturer, like India-based companies, and need to sell medical devices in the U.S.
- But 510k clearance is not needed for all medical devices. Class I (low-risk) products such as bandages or tongue depressors are exempt. Class III products (life-sustaining, high-risk products) typically need a more extensive Pre-Market Approval (PMA) in place of a 510(k).
510k Submission Process
The 510k Medical Device submission is a process that has many steps:
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Classify the Device
The FDA categorizes devices as Class I, II, or III depending on the risk level. The majority of 510(k) devices are Class II.
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Find a Predicate Device
You need to identify a predicate device that has previously been cleared by the FDA and shares similar technology and functions.
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Perform Performance Testing
Firms need to perform biocompatibility, electrical safety, and software validation tests to demonstrate that the device is safe and effective.
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Ready 510k Submission
The submission should contain:
- Device description
- Predicate device comparison
- Test reports
- Labeling and intended use
- Safety and performance data
- File with the FDA and Wait for Clearance
FDA reviews the submission within 90 days on average. If approved, the device can be sold in the US.
How Indian Manufacturers Can Get US FDA Certification?
To access the U.S. market, Indian medical device producers have to get US FDA Certification in India. The process involves:
- Register with the FDA – Indian companies have to register their company and their medical devices with the FDA.
- Appoint a U.S. Agent – A United States-based agent has to serve as a regulatory contact point.
- Comply with FDA Regulations – Make sure the device is in accordance with Quality System Regulation (QSR) requirements.
Submit a 510k Application – File all required documents and test results
510k Medical Device filing is necessary for companies that wish to market Class II medical devices in the US market. US FDA Certification in India is essential for Indian manufacturers as a vital step to accomplish regulatory compliance and business growth. The knowledge of the 510k process helps manufacturers get past FDA regulations and introduce their medical breakthroughs into the world.
If you want any other guidance relating to the US FDA Certification, please feel free to talk to our business advisors at 8881-069-069.
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