FDA Regulation of Medical Devices and Medical Device Reporting

FDA Regulation of Medical Devices and Medical Device Reporting

There are three main stakeholders in medical device regulation: people in industry, regulators and practitioners. A medical device report is filed after a device-related adverse event occurs. Studies show that while most medical device reports begin with practitioner observations, people in industry file 97% of reports and practitioners file 3% of reports. The objectives of this article are to ...

FDA medical device regulation and informed consent.

New medical devices are subject to a regulatory scheme designed to ensure safety and effectiveness that is administered by the United States Food and Drug Administration (FDA). Gaining approval to market a device for a specific clinical indication may be time-consuming and costly, particularly for one that poses a potentially unreasonable risk of patient injury and represents genuinely new medi...

FDA Flags Inconsistent Hospital Reporting Of Medical Device Problems: Hazy Reporting Rules Beget Confusion.

The National Evaluation System for Health Technology will be developed over the next five years to upgrade and improve the reporting of medical device adverse events. However, participants using the new system will incur significant capital costs.

Reporting of Cardiovascular Medical Device Adverse Events to Pharmaceuticals and Medical Devices Agency, Japan☆

BACKGROUND Marketing authorization holders (MAHs) are obligated to report adverse events (AEs) within 15 days (some cases 30 days) to the Pharmaceuticals and Medical Devices Agency (PMDA) of Japan. METHODS To analyze the timeliness of AE reporting to the PMDA, 6610 reports for five categories of cardiovascular devices were retrieved. Two durations were calculated: (1) time from the date the A...

The FDA and the Regulation of Medical Device Innovation: A Problem of Information, Risk, and Access