This article focuses on 510(k) submissions to the US FDA. A 510(k) is a premarket submission made to the FDA to demonstrate that the device to be marketed is as safe and effective as a legally marketed device, i.e. substantially equivalent (Section 513(i)(1)(A) of the Federal Food, Drug, and Cosmetic Act). Submitters compare their device with one or more similar legally marketed devices and make and support their substantial equivalence claims.
1. What Is Substantial Equivalence?
A 510(k) must demonstrate substantial equivalence to another device already legally marketed in the US. A device is substantially equivalent if, compared with a predicate device,
it meets the following conditions:
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It has the same intended use as the predicate and the same technological characteristics as the predicate.
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It has the same intended use as the predicate and different technological characteristics that do not raise different questions of safety and effectiveness, and the device is as safe and effective as the legally marketed device.
A finding of substantial equivalence does not mean the new device must be identical to the predicate. The key is to confirm that the new device has the same intended use as the predicate and that any differences in technological characteristics do not raise different questions of safety and effectiveness.
In addition, whether the new device is as safe and effective as the predicate is determined by evaluating the scientific methods used to assess differences in technological characteristics and the performance data.
Such performance data may include clinical data and non-clinical laboratory performance data, covering engineering performance testing, sterility, electromagnetic compatibility, software validation, biocompatibility assessment and more.
2. Who Needs to Submit a 510(k)?
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Domestic manufacturers introducing a medical device to the US market.
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Specification developers introducing a medical device to the US market whose manufacturing is contracted to another company or entity. The 510(k) is submitted by the specification developer, not the contract manufacturer.
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Repackagers or relabelers who make labeling changes or whose operations significantly affect the device. Significant labeling changes may include changes to the IFU such as adding a new intended use or deleting or adding warnings or contraindications; operations such as sterilization may alter the condition of the device. However, most repackagers or relabelers do not need to submit a 510(k).
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Foreign manufacturers/exporters, or their US representatives, introducing a device to the US market
3. The Third Party Review Program
The FDA’s Center for Devices and Radiological Health (CDRH) runs a Third Party Review Program (3P510k review), under which 510(k)s are submitted to FDA-recognized private organizations (Accredited Third Parties) for review rather than directly to CDRH.
The FDA delegates the initial review of 510(k)s for low/moderate-risk, low-complexity devices to third parties, focusing internal resources on high-risk/complex devices and offering companies a faster route for premarket notification review (participation is voluntary).
For companies this is an option for submitting a 510(k) – more expensive but with greater confidence of passing. Note, however, the situations not eligible for the third party review route:
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Devices for which the company’s previous 510(k) received an NSE (not substantially equivalent) decision or was withdrawn are not eligible for the 3P510k route.
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Only Class I/II devices are eligible; Class III devices are generally not.
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Permanently implantable and life-sustaining/supporting devices without a public health justification are generally not eligible.
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Devices of new technology / classified through the De Novo process are generally not eligible.
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Devices requiring multidisciplinary / multi-center FDA review are generally not eligible.
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Devices with post-market safety signals (recalls, safety alerts) are generally not eligible.
4. 510(k) Documentation Requirements
The core sections and requirements of the 510(k) electronic submission template are as follows:
Link to the 510(k) electronic submission template for more detailed requirements
5. Information Available from the FDA
Consistent with the information in 510(k) summaries publicly available on the FDA website, the core content includes:
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Submitter information (name, contact details, date)
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Device information (name, model, classification, product code)
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Predicate device identification (name, 510(k) number / PMA number)
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Device description (components, materials, principle of operation, use environment)
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Intended use (including explanation of differences in indications)
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Comparison of technological characteristics
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Summary of performance data (non-clinical / clinical test methods, results, adverse events)
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Substantial equivalence (SE) conclusion
Question 1: A distributor wants to distribute a manufacturer’s product under the distributor’s own company name. Does it need to submit a 510(k)?
Answer: No. The manufacturer should submit the 510(k) as required for the device. If the device is not made by the manufacturer named on the label, the name must be accompanied by a statement of its connection with the device, such as “Manufactured for ABC Company”, “Distributed by ABC Company” or other wording that accurately describes the situation.
Question 2: Can foreign companies submit a premarket notification 510(k)?
Answer: Yes. Foreign manufacturers can submit 510(k)s directly to the US FDA. For convenience, they may obtain assistance from a US entity and may designate a contact person residing in the US.
Question 3: Do I need to register my establishment before submitting a 510(k)?
Answer: No. If the company is newly established and has not yet manufactured any medical devices, it should register within 30 days before starting production and distribution of the device. The 510(k) should state that the company is not yet registered.
Question 4: (1) Do I need to provide documentation in the 510(k) showing that the establishment complies with the quality system? (2) Must my facility be inspected under the quality system regulation before submitting a 510(k)?
Answer: (1) No. But for a Special 510(k), a statement of compliance with quality system design control requirements must be provided. (2) No. A pre-approval inspection is not a prerequisite for 510(k) clearance. However, you should be prepared for an FDA inspection at any time.
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510(k) Third Party Review Program
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Template for Medical Device 510(k) Submissions
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User Fees and Refunds for Premarket Notification Submissions (510(k)s
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The 510(k) Evaluating Substantial Equivalence in remarket Notification
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Conclusion
This is a series of educational articles introducing regulations and standards of the FDA, NMPA, GMP, CE MDR/IVDR and MDSAP.
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