Medical devices of all kinds are regulated by the Food and Drug Administration (FDA) in the United States.
Healthcare businesses that create medical device products are required to stay up-to-date with current medical device development regulation and law and to ensure that they are in compliance at all times.
It is also important for healthcare businesses that use medical devices to stay in the know when it comes to product regulation changes and updates.
What Are Medical Devices?
Medical devices include any component, accessory, part, machine, instrument, apparatus, implant, or in vitro reagent that is used for the purposes of diagnosing, preventing, mitigating, or treating a medical condition or disease.
Some combination products that are a device but also biologically inserted into the body and/or release a drug into the body are included in medical device laws.
Medical device regulations exclude drugs and certain software that manage administration of a medical office or support the storage of patient records.
What Is Pharmaceutical and Medical Device Law?
Medical device law and pharmaceutical device law codify medical devices according to different levels of risk and controls. For example, Class I medical devices are the lowest risk, and Class III medical devices have the highest risk.
Depending on the class of the medical device, medical device law and regulations may require:
- Labeling that provides user information.
- Medical device reporting of injuries or death that are related to use of the device.
- Registering the business and all devices with the FDA.
- Implementing a quality control system.
- Avoiding misbranding or other misinformation.
Does Your Business Need Help Maintaining Medical Device Regulation Compliance?
Contact Florida Healthcare Law Firm today to discuss potential issues you may be facing due to medical and pharmaceutical device law. You’ll get the support you need to create a compliance plan and avoid any potential legal violations and legal restraints from the FDA.