The US regulating authority announced changes to existing regulations related to the reporting of medical devices. The information on upcoming changes was published in the recent report on breast implants and their related risks as the result of special investigation held by the FDA. This special investigation was conducted to find out whether the various existing types of breast implants could cause negative consequences to the health of women. For that purpose, the regulating authority analyzed the data on postmarketing reporting, including clinical trial reports and special injury reports. Despite the fact that there was no hard evidence of breast implants causing a negative impact to the health of patients, the FDA decided that some implants may act as a factor in harm to the immune system. The investigation confirmed the important role that collecting data on the actual usage of medical devices plays — it aided the FDA to make a decision to improve the existing reporting system.


New requirements

According to the new reporting rules, the companies manufacturing medical devices would have to file reports on each individual device. These reports would be accessible through a specific website.

The main goal of the changes is to increase the transparency and awareness of the potential risks a device holds for the patients to be aware about. At the same time, the existing rules provide a special type of reporting, known as “alternative summary report”. Reports of such type are already available on the specific website. Another form of reporting, the Postmarket Spreadsheet Report, will cease to exist. These new changes will influence the reporting rules for breast implants, but moving forward a similar principle may be applied to other types of medical devices if it proves to be efficient and meets primary endpoints.


All manufacturers of medical devices obliged to find reports on issues related to the use of their devices. All reports aim to detect possible substantial risks connected with the use of medical devices. In case of distributing medical devices manufactured by a foreign company, the local representative of the company would be responsible for postmarket communications and filing all reports to the domestic regulating authority. Local representatives also obliged to transmit any claims of the customers to the manufacturer. The forms of the reports may vary depending on the country and requirements of particular regulating authorities. For example, the existing legislation of the United States provides the option to apply for exclusions or alternative forms of reporting which creates additional flexibility for the manufacturers. Each application would be evaluated individually, but the general rule states that all important data should be published. The FDA uses a special informational website (database) to publish reports on medical devices. The data collected through the reporting system could also be used by the FDA while investigating any cases of injury related to the use of medical devices and could be very helpful for the confirmation of safety of a particular device.

The numbers

1, 1 million Reports collected though the alternative summary reporting  
190,000 Injury reports for first nine month of 2018
45,000 Malfunction reports for the same period


The FDA also stated that the new requirements would also update the labelling requirements. According to the importance of the information on safety and risks connected with medical devices, the FDA announced it would work closely with groups of potential customers to jointly develop the new labelling requirements to ensure that labelling would contain all important information and the potential patients would be able to find and understand this information with ease.

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