On Monday, August 4, the @US_FDA will host a public meeting to discuss recommendations for the reauthorization of the Medical Device User Fee Amendments for fiscal years 2028 through 2032 (MDUFA VI). Find out more and register today.

Sponsors of device studies and manufacturers of devices are reminded to carefully evaluate the third parties they engage to conduct safety, performance, and cybersecurity testing and to independently verify all testing results before submitting to the FDA.

Until the firm adequately addresses these issues, all study data from all studies conducted at this testing facility will be rejected.

We have determined that Sanitation & Environment Technology Institute of Soochow University dba SDWH has, in several instances, copied the results of another study or created falsified or otherwise invalid data that was submitted to FDA.

The FDA has noted an increase in unreliable testing data generated by third-party testing facilities on behalf of device manufacturers and sponsors.

“Do you have questions about reporting requirements for medical device convenience kit manufacturers? Visit our new FAQ page titled Convenience Kit Reporting Requirements for Corrections, Removals, and Recalls, to learn about your responsibilities.”.

FDA has identified Medtronic’s removal of certain Aortic Root Cannulas due to unexpected loose material that occurred during the manufacturing process as a Class I recall, the most serious type of recall. Find out more:

The FDA continues to take actions that support the development and availability of at-home tests for a variety of medical conditions.

Expanding access to STI testing is an important step toward earlier and increased diagnosis, which can result in increased treatment and reduction in the spread of infection.

Today’s authorization will give people information about their health from the privacy of their home. This can be particularly important for sexual health tests for which patients may experience fear or anxiety, possibly resulting in delayed diagnosis or treatment.

Although Essure, a permanently implanted birth control device for women, has not been available for implantation since December 2019, the FDA remains committed to collecting and providing updates on the long-term safety information about this device.

The @US_FDA updated the Problems Reported with Essure web page to include information on the medical device reports received by the FDA related to Essure in 2024.

The @US_FDA identified a Class I Recall, the most serious type of recall: Smiths Medical is recalling ORAL/NASAL Endotracheal Tubes after becoming aware that certain sizes of ORAL/NASAL Endotracheal Tube products may have a smaller diameter than expected.

This recall involves correcting software for devices and does not involve removing them from where they are used or sold.

Today, the @US_FDA identified a Class I Recall, the most serious type of recall: Becton, Dickinson and Company (BD) issues correction for BD Alaris Systems Manager and Care Coordination Engine Infusion Adapter Software. Learn more:.

The @US_FDA issued an Early Alert: Aspiration System Issue from Calyxo.

This recall involves removing certain devices from where they are used or sold. This device may cause serious injury or death if you continue to use it.

Today, the @US_FDA identified a Class I Recall, the most serious type of recall: Smiths Medical removes ProPort Plastic Implantable Ports due to manufacturing error that may cause separation. Learn more:

The @US_FDA identified a Class I Recall, the most serious type of recall: Medtronic has removed the Pipeline Vantage 027 device models and is updating instructions for using the Pipeline Vantage 021 device models. Find out more:

The agency has also determined that the shortages of blood culture media bottles (product code MDB) and Container, I.V. (product code KPE) are resolved and have been removed from the MDSL. Find out more: