Medical devices that are meant for human use are classified by the FDA as Class I, Class II and Class III, depending on the nature and the use they are put to. Some of these do not require a premarket notification (PMA); in such cases, the manufacturer has to obtain what is called a 510 (K) clearance. This has to be done for any device that requires 510 (K) clearance, i.e., a device that the FDA Act has not exempted from obtaining a 510 (K) clearance.
When is a device fit for commercial distribution?
A 510 (K) clearance paves the way for the commercial distribution of a medical device. This clearance is issued by the FDA is satisfied about the device’s substantial equivalence (SE). Being substantially equivalent means that the device should be at least as safe, if not safer, than an equivalent, legally marketed device already in the market, and which is not subject to PMA. Such a device is called a predicate device.
So, a 510 (K) is said to have been obtained when the manufacturer gets the go ahead from the FDA that the device is fit to enter the market. This is after the regulatory body issues a letter to this effect.
The FDA does not on its own carry out a 510 (K) process. It requires medical device manufacturers to submit documents for getting a 510 (K) clearance.
Who is required to submit a 510 (K)?
Rather than stating which kind of manufacturer has to submit a 510 (K); the FDA specifies all the types of actions that warrant one. Accordingly, these types of manufacturers have to obtain 510 (K) clearance from the FDA:
- Domestic (American) medical device manufacturers that plan to introduce a device in the US market
- Foreign manufacturers or exporters who introduce their device into the US market, or their representative
- Developers of specifications, who introduce a device into the US market
- Any repacker or labeler who makes significant changes into the product
Situations in which a 510 (K) clearance is needed
A 510 (K) clearance is required in the following situations:
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