FDA issues draft “safer technologies programme for medical devices” guidance

Jeff Shuren The FDA has issued draft guidance titled “safer technologies programme for medical devices”, which is a voluntary programme that—a press release reports—is expected to significantly improve the safety of available treatments or diagnostic devices for diseases or conditions that are less serious than those eligible for the agency’s Breakthrough Devices [...]

2019-09-20T13:31:46+00:00September 20th, 2019|Tags: |

The FDA finalises its draft guidance on the Humanitarian Device Exemption programme

Jeffrey Shuren The FDA issued a final guidance, Humanitarian Device Exemption (HDE) programme, with the aim of providing provide updated information about the HDE application process and other considerations specific to the programme. An HDE application is the premarket submission for a Humanitarian Use Device (HUD), which is a medical device intended [...]

2019-09-06T18:04:25+00:00September 6th, 2019|Tags: |

FDA recalls delivery system of Sapien 3 Ultra within a week of approving it for low-risk patients

The FDA has issued a Class I recall—which it describes as “the most serious type of recall”—for the delivery system of the Sapien 3 Ultra transcatheter aortic valve implantation (TAVI) system. The recall follows Edwards Lifesciences receiving reports of burst balloons during implantation procedures, and it comes just under a week after the FDA [...]

FDA formally ends its Alternative Summary Reporting programme

Jeffrey Shuren In a statement, published on the its website, the FDA has outlined the steps it is taking to update its Medical Device Reporting (MDR) programme—one of the tools the FDA uses to monitor device performance, detect potential device-related safety concerns or signals and contribute to the benefit-risk assessment of these [...]

2019-07-08T16:18:45+00:00July 8th, 2019|Tags: , |
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