FDA - Articles - Page 58

‘23 in review

US FDA, Congress, fail to resolve lab-developed test mess

Dec. 27, 2023

As calendar year 2023 limps to the finish line, a number of important regulatory developments emerged and then submerged, but one development that is also a non-development took center stage in the world of med tech. The U.S. FDA has proposed a regulation for lab-developed tests (LDTs), an issue that has been simmering for the better part of a decade thanks in no small part to Congress’ failure to pass legislation that would eliminate the FDA’s controversial approach to rulemaking.

FDA final guidances address digital health and more

Dec. 22, 2023

By Mari Serebrov

With the clock ticking down on 2023, the U.S. FDA seems to be scurrying to push final guidances out the door before the new year. This week, the agency has finalized several guidances, ranging from the use of digital health technology in clinical trials to the use of real-world data (RWD) in drug development.

Glaukos sees bright future for Idose with FDA greenlight

Dec. 21, 2023

By Annette Boyle

Glaukos Corp. brought home a nice year-end gift for investors with a broad U.S. FDA approval for the Idose TR. Indicated for use in patients with primary open-angle glaucoma or ocular hypertension across the full range of disease severity, the device/drug combo provides continuous release of a prostaglandin analog that reduces intraocular pressure via a titanium device implanted through a corneal incision for up to three years.

Neuroone’s ablation system for neurological disorders gets FDA greenlight

Dec. 18, 2023

By Shani Alexander

Neuroone Medical Technologies Corp. received U.S. FDA 510(k) clearance for its Onerf ablation system which is capable of both recording electrical activity and ablation of nervous tissue.

FDA draft guidance for 510(k) clinical data draws fire

Dec. 15, 2023

By Mark McCarty

The FDA’s ongoing efforts to modernize the 510(k) program produced three draft guidances in the waning days of fiscal year 2023, one of which is a draft for the scenarios in which clinical data would be required for a 510(k) application.

Industry sees US FDA’s predicates draft guidance as extralegal

Dec. 14, 2023

By Mark McCarty

The U.S. FDA’s draft guidance for selection of a predicate device in 510(k) submissions is part of a larger effort to overhaul the 510(k) program, but industry’s response is that this draft guidance goes too far.

AI could overwhelm ability of US FDA to keep up

Dec. 13, 2023

By Mark McCarty

Artificial intelligence has morphed from a buzzword referencing a popular curiosity to a series of national security and competitiveness considerations, which was reflected in the tone of a recent hearing in the U.S. House of Representatives.

2023 FDLI Enforcement Conference

FDA facing a ‘somewhat unimaginable’ volume of applications for LDTs

Dec. 8, 2023

By Mark McCarty

The U.S. FDA’s draft rule for lab-developed tests (LDTs) has proven to be every bit as controversial as expected, although the controversy is only marginally about the workload that would come with rulemaking.

2023 FDLI Enforcement Conference

Abiomed warning letter for final deviation seen as opening salvo

Dec. 7, 2023

By Mark McCarty

The U.S. FDA’s recent warning letter to Danvers, Mass.-based Abiomed Inc., may have come across as an enforcement outlier in the context of the agency’s controversial final guidance for clinical decision support (CDS) products.

FDA approved icons and medical professional

2023 FDLI Enforcement Conference

FDA tells industry to get serious about UDI compliance

Dec. 6, 2023

By Mark McCarty

The unique device identifier (UDI) might not be the most exciting U.S. FDA enforcement mandate for most of regulated industry, but the FDA’s Keisha Thomas indicated that compliance is less than adequate in the agency’s view.

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US FDA, Congress, fail to resolve lab-developed test mess

FDA final guidances address digital health and more

Glaukos sees bright future for Idose with FDA greenlight

Neuroone’s ablation system for neurological disorders gets FDA greenlight

FDA draft guidance for 510(k) clinical data draws fire

Industry sees US FDA’s predicates draft guidance as extralegal

AI could overwhelm ability of US FDA to keep up

FDA facing a ‘somewhat unimaginable’ volume of applications for LDTs

Abiomed warning letter for final deviation seen as opening salvo

FDA tells industry to get serious about UDI compliance

Today's news in brief

Today's news in brief

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FDA, Medical technology
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