USFDA 510(k) Premarket Notification
Introduction
510k clearance is required for all non-exempt medical devices that fall into risk Class II. The 510k clearance process is the most common pre-market pathway used by medical device companies to legally sell products in the US. The requirements for a 510(k) submission is described in 21 CFR 807 Subpart E.
A 510(k) is a premarket submission made to FDA to demonstrate that the device to be marketed is as safe and effective, that is, substantially equivalent, to a legally marketed device (section 513(i)(1)(A) FD&C Act). Submitters must compare their device to one or more similar legally marketed devices and make and support their substantial equivalence claims.
FDA does not typically perform 510(k) pre-clearance facility inspections. The submitter may market the device immediately after 510(k) clearance is granted. The manufacturer should be prepared for an FDA quality system (21 CFR 820) inspection at any time after 510(k) clearance.
Who is Required to Submit a 510(k)
The following four categories of parties must submit a 510(k) to the FDA:
- Domestic manufacturers introducing a device to the U.S. market.
- Specification developers introducing a device to the U.S. market.
- Repackers or relabelers 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.
Types
There are three types of Premarket Notification 510(k)s that may be submitted to the FDA: Traditional, Special, and Abbreviated.
1. Traditional 510(k)
- Most common type.
- This is an original submission that normally has to be provided for the medical device, that requires FDA 510k clearance according to 21 CFR 807
- You must show that your device is substantially equivalent to a device already legally on the market (called a predicate device).
- You need to submit complete testing and documentation (like bench tests, biocompatibility studies, etc.).
- No specific timeline; FDA generally reviews it within 90 days.
2. Special 510(k)
- For modifications to your own previously cleared device.
- You can submit a Special 510(k) if changes do not affect the intended use or alter fundamental scientific technology.
- It's meant to be a faster review – typically 30 days.
- You still need to provide validation and verification of the changes.
3. Abbreviated 510(k)
- Used when there are FDA guidance documents, special controls, or recognized consensus standards that apply to your device.
- Instead of full testing, you show conformance to recognized standards.
- Often shorter and simpler if those standards exist for your device type.
- Review timelines are similar to a Traditional 510(k).
How to Submit a 510(k)
All 510(k) submissions, unless exempted, must be submitted as electronic submissions using eSTAR.
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