The history of the FDA and regulations on medical devices can be traced backed to
“the appointment of Lewis Caleb Beck in the Patent Office around 1848 to carry out chemical analyses of agricultural products, a function that the newly created Department of Agriculture inherited in 1862”.
Over time, many new regulations and laws were placed on agriculture, food and eventually drug production.
The FDA regulation milestones for medical devices started in 1966 with the Fair Packaging and Labeling Act. The Act requires all consumer products in interstate commerce to be honestly and informatively labeled, with FDA enforcing provisions on foods, drugs, cosmetics, and medical devices. At this point in time, companies were producing medical devices without a formal evaluation of the device by the FDA.
In 1976, the Legislature passed the Medical Device Amendments to ensure safety and effectiveness of medical devices. The amendments required manufacturers of medical devices to register with FDA and follow quality control procedures. The law also set standards for certain products to have pre-market approval by the FDA.
In 1990, the Legislature passed the Safe Medical Devices Act , requiring nursing homes, hospitals, and other facilities that use medical devices to report to the FDA incidents that suggest that a medical device probably caused or contributed to the death, or serious injury of a patient. The act also required manufacturers to conduct post-market surveillance on permanently implanted devices whose failure might cause serious harm or death, and to establish methods for tracing and locating patients depending on such devices. The act also authorized the FDA to order device product recalls and other actions.
In 1997, after complaints of a slow medical device approval process from medical device manufacturers of class 1 devices. The Legislative branch enacted the Food and Drug Administration Modernization Act to accelerate review of medical devices. The Modernization Act exempts premarket notification of class 1 devices that are not intended for critical human health. In addition, the Act authorized “third-party” experts to conduct initial review of low-to-intermediate risk class 1 and 2 devices. Low-risk devices are not considered life-supporting or implantable according to the FDA Modernization Act of 1997.
In 2002, the Legislature passed the Medical Device User Fee and Modernization Act which mandated fees to medical device companies for evaluation or approval of medical devices. For example, for an FDA review of a medical device, also known as a Medical Device User Fees 510 (k) review , a company will pay $4,960. Provisions were also established for device inspections by accredited third-parties, and new requirements emerge for single-use devices. The Act also created the Office of Combination Products, to oversee review of products that fall into multiple jurisdictions within the FDA. An example would be a drug delivery device like the Combination Medical Device – Neupro Patch which delivers a drug through the skin to treat Parkinson’s disease.
At Sparx Engineering, we are always trying to stay abreast on the latest FDA regulations. We often partner with academic organizations to build tools and technology to support clinical research, always with an eye during development to how positive results can be clinically fielded. In many cases, the largest obstacles to overcome are not the technical hurdles, but the regulatory hurdles. Understanding this landscape is key to producing results that find their way to the consumer.
In one of our most recent projects funded by the US Air Force, Sparx is developing a research tool for a University of Cincinnati study on Closed Loop Control of Oxygenation. We are creating a control system to interface a ventilator with an oxygen concentrator, whereby the ventilator controls the timing and volume of oxygen delivery from the concentrator (shown left).