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 or bandages to blood glucose meters or pacemakers.
The health care professionals at SafetyCall have over fifteen years of experience responding to and documenting Medical Device Reporting (MDR) events. All MDRs are reported, documented and stored in SafetyNotes, our proprietary case management software application. Clients have access to their incident data 24/7 utilizing SafetySearch, a secured password protected web-based search engine.
|Regulatory Agencies||Applicable Federal Laws|
|US Food and Drug Administration (FDA)||21 CFR 803|
Highlights – Rules & Regulations
Two important regulations applicable to the Medical Device industry that are a focus of SafetyCall services are 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.
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Your Industry Obligations
Medical device registrants must also consider the following compliance obligations:
- When considering the MDR reporting requirements for medical devices, manufacturers of diagnostic testing devices such as glucometers must evaluate each report of an inaccurate measurement to determine if the inaccuracy may have indirectly resulted in serious injury.
- 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
Guidance Documents Reporting Adverse Events Forms Read more at fda.gov
Read more at fda.gov Blank-CIOMS-I-template.pdf