PMA = Pre Market Approval
Class I: Simple devices with a minimal risk to the user. Most of these devices are exempt from FDA clearance or approval. Examples: crutches, elastic bandages, bedpans.
Class II: Moderate level of risk to the user. Almost all of these devices require a regulatory submission before they can be legally marketed. As a rule, class II devices require 510(k) submissions. Examples: administration sets, sutures, inflatable blood pressure cuffs.
Class III: These devices pose a serious level of risk to the user, mostly because they are implants or sustain life. All of these devices require a regulatory submission before they can be legally marketed. As a rule, class III devices require a PMA (Premarket Approval) submission. Examples: implantable pacemakers, blood vessel stents, breast implants.
The purpose of a 510(k) submission is to demonstrate that a device is “substantially equivalent” to a predicate device. The 510(k) submitter compares and contrasts the subject and predicate devices, explaining why any differences between them should be acceptable. Manufacturers may also submit a 510(k) if they alter their device. Not all changes require a 510(k) submission. In general, changes to a device’s intended use, contraindications, or basic operation require a new 510(k) clearance. Changes to blood-contacting materials, sterilization method, or performance specifications may also require a new 510(k).
The FDA does not “approve” 510(k) submissions. It “clears” them.
Premarket Approval (PMA)
A PMA submission is used to demonstrate to the FDA that a new or modified device is safe and effective. This standard is higher than is required for 510(k) submissions. Human use data from a formal clinical study is almost always required in addition to laboratory studies.
PMA devices can be legally advertised as “PMA-approved” or “FDA-approved.”