The FDA has some clear-cut requirements that those manufacturing medical devices have to meet in order to get their products approved. FDA requirements for medical devices cover regulations for these devices, based on the way they are classified, and for meeting set regulatory guidelines.
The FDA classifies medical devices according to the extent of their use and the potential they have for causing risk. FDA requirements for medical devices are based on this classification. This is how the FDA classifies medical devices:
Class I:These devices are considered least complicated in terms of their use, design and potential harm. This is why FDA requirements for medical devices are minimal, since their failure is likely to result in the least risk to the user. Examples of Class I medical devices are plasters and dressing kits. According to the FDA, 47 percent of all medical devices grouped into Class I.
Class II: FDA requirements for medical devices for Class II devices are based on the nature of these devices, which are considered slightly more complicated than Class I medical devices and have the potential to cause slightly higher injury in the case of failure. 43 percent of all FDA-approved devices fall in this category, whose examples could include test kits and wheelchairs.
Class III: Class III medical devices are those that are serious in the nature of their risk. These devices also carry the highest level of use for the user. Constituting barely a tenth of all medical devices; Class III medical devices could include life supporting systems such as pacemakers.
An important aspect of FDA requirements for medical devices is that a marketing application has to be submitted by the device’s makers if they have to get approval for marketing the device. FDA requirements for medical devices exempt many kinds of devices from this submission, but require their makers to be subject to the usual controls that are part of FDA requirements for medical devices.
General FDA requirements for medical devices
All medical devices from any manufacturer have to satisfy the following criteria to get approved:
Criteria for FDA requirements for medical devices:
The FDA has a few criteria that manufacturers of medical devices have to meet in order to have their medical devices approved:
1. 510 (K):
FDA requirements for medical devices include the 510 (K) submission, which is a submission that medical device manufacturers have to make to declare that their device is at least as safe as any other device in its category already in the market, or what is called Substantially Equivalent (SE).
2. Premarket approval:
The PMA is a request that a manufacturer makes to the FDA, by which it asks for clearance from the FDA to market a new Class III device or to continue to market an existing one in the same category.
3. Investigational Device Exemption:
An IDE is a mechanism by which the manufacturer of an investigational device is allowed permission to use effectiveness and safety data that can be used for making either a 510(K) submission or a PMA application to the FDA.
4. Good Manufacturing Practices:
FDA requirements for medical devices include GMP requirements to be met in all the areas of manufacture in accordance with the principles laid out in a Quality System (QS), such as designing, manufacturing, labelling, storing, installation and servicing of finished products.