Consumer Medical Devices

The Medical Device industry is very broad. By definition, it is an apparatus, implant or in vitro reagent that is used to diagnose, prevent or treat disease or other conditions without the use of a chemical action within or on the body. Medical devices can vary in their complexity. Examples range from tongue depressors, bandages to blood glucose meters to pacemakers.

Regulatory Agencies and Applicable Federal Laws

US Food and Drug Administration (FDA)

Medical Devices

Highlights – Rules & Regulations

An important regulation applicable to the Medical Device Industry that is a focus of SafetyCall service is highlighted below.

21 CFR 803

Upon becoming aware of an MDR event that is serious or resulted in fatality, the manufacturer must report the MDR event to the FDA within 30 calendar days.
Upon becoming aware of an MDR event that is not serious but could result in serious injury should the malfunction recur, the manufacturer must report the MDR event to the FDA within 30 calendar days.
Upon becoming aware of an MDR reportable event that necessitates remedial action to prevent an unreasonable risk of substantial harm to public health, the manufacturer must report the event to the FDA within 5 calendar days.

Your Industry Obligations

Medical device registrants must also consider the following compliance obligations:

Causality is not a prerequisite for tracking and reporting adverse events associated with the use of medical devices in the USA. Even if a registrant does not believe there is sufficient scientific evidence to support an assertion that an alleged adverse event may have been caused by a medical device, the registrant is still mandated to report serious adverse event to the FDA within 30-days of notification.
21 CFR 803 establishes the requirements for reporting of medical device adverse events.

Industries served

Consumer Medical Devices

21 CFR 803