Tracking information may be used to facilitate notifications and recalls ordered by FDA in the case of serious risks to health presented by the devices. The regulations implementing the tracking requirements became effective on August 29, 1993 and can be found in 21 CFR Part 821.
Electronic messages posted on the Rx2000 Solutions Institute listserver raise concerns that 15 instruments from seven manufacturers of medical devices will not work correctly after December 31, 1998. The e-mail alleges these products will not be able to accommodate the transition from December 31, 1998 to January 1, 1999.
Although a large number of topics emerged from this survey, six major trend categories circumscribe all of the product-type examples. The resulting applications in the clinical community were administrative patient data bases (1970s), computerized medical diagnosis programs (ca.
Talking portable defibrillators have been around for years, guiding users through the steps of saving a cardiac arrest victim. Other high-tech health tools help teach operating room staffers how to assemble the complicated set-ups of rarely used surgical devices.
FDAs June 22, 2007 consent order with Shelhigh, Inc., Union, N.J., has generated interest from the medical community and the general public. This action follows the April 17, 2007, seizure of all implantable devices at Shelhighs Union, NJ manufacturing facility.
The medical devices include such products as hearing aids, contact lenses, magnets, and laboratory diagnostic test kits. Types of medical devices range from thermometers to artificial hearts to at-home pregnancy test kits.
Cardiac medicine is just one of many therapeutic areas virtually transformed by innovations in medical technology. Breakthroughs such as coronary stents, implantable defibrillators and minimally invasive bypass surgery have helped reduce the death rate from heart disease by 40 percent since 1980.
The novel system is described in a paper published in the online Nature journal Scientific Reports. It is estimated that around 300,000 patients worldwide are prevented from receiving MRI exams each year because of implanted devices.
Scientific evidence from clinical trials must be provided by the manufacturers demonstrating the safety and effectiveness of their product. Over-the-counter drugs are monitored by the FDA, but they are submitted to a less rigorous testing procedure, especially if they are assumed to be safe.
Before a medical device is recommended, doctors will probably want their patients to have tried lifestyle changes that include healthy eating and increased physical activity. Even if a person is prescribed an obesity treatment device, he or she still must make lifestyle changes.
Additionally, the ... full story Oct. 10, 2014 A novel technique that reduces image degradation caused by respiratory motion during a PET scan was developed through a recent study. PET scanning is routinely used to detect cancer and heart ... full story Oct. 9, 2014 Cardiologists have implanted an investigational cardiac pacemaker the size of a multivitamin.
Summary of Problem and Scope: Many medical devices contain configurable embedded computer systems that can be vulnerable to cybersecurity breaches. The FDA has been working closely with other federal agencies and manufacturers to identify, communicate and mitigate vulnerabilities and incidents as they are identified.