Labeling

• According to the U.S. Food and Drug Administration, pacemakers must have a label with a warning as to when a battery will likely wear out. Other warnings should be clearly labeled on the device to guide the patient on any interference that may result if the pacemaker is used in certain environments.
  
  

Tracking Requirements

• The FDA requires manufacturers to track pacemakers and defibrillators. The Safe Medical Devices Act of 1990 sets tracking regulations to ensure that pacemakers are tracked from the point of production to the point of distribution to a patient. Tracking ensures the manufacturer is available if a patient wants to give notice about an interference problem or a malfunction.
  
  

Susceptibility Regulations

• The FDA requires that pacemaker manufacturers incorporate electromagnetic shielding in the devices. This ensures that modern pacemakers are protected from radio frequency signals that can interfere with the device's electronic circuitry. Manufacturers are also required to test their devices for susceptibility to electromagnetic interference using a wide range of frequencies. Results of this test must be submitted to the FDA before the device can be approved for the market.
  
  

Legal Rights

• Patients using pacemakers may be entitled to sue the manufacturer and suppliers for negligence, for breach of the warranty and strict liability as permitted by state laws. Some medical devices that already have pre-market approval from the FDA may be exempted from product liability lawsuits. But a patient may still sue the manufacturer if the manufacturer did not make the product according to the safety requirements laid out in FDA requirements.