United States

A new AI lifecycle management framework from the US FDA’s Digital Health Center of Excellence introduces considerations for the seven steps of the AI lifecycle.

The US FDA has created a web page with answers to common questions concerning the agency’s final rule on regulating laboratory developed tests as medical devices.

The US FDA device center head is retiring after 28 years in the federal sector and 15 at the helm of CDRH. Deputy center director Michelle Tarver will step in as acting head.

Senior leadership in the FDA’s drugs, biologics and devices centers want reviewers to feel more comfortable taking risks in product approvals, but may need more concrete examples of regulatory flexibility's success to convince them.

The US FDA has issued two new warning letters to Chinese syringe makers Jiangsu Shenli and Jiangsu Caina following inspections of their facilities. The letters are the latest in what has been an ongoing investigation into these devices.

The document explains how user fees for combination products are assessed and administered, as well as waiver possibilities.

Firms can be more forceful in disputes with FDA now that Supreme Court has eliminated Chevron deference. Questions around whether an evidentiary standard has been met may be ripe for challenge, legal experts said, but they also caution that sponsors will face more uncertainty.

US Customs and Border Protection ruled that Apple’s ECG technology doesn’t infringe on AliveCor’s patent and doesn’t have to comply with a previous import ban.

The accelerated approval of Rezdiffra, the first drug authorized by the FDA to treat metabolic dysfunction-associated steatohepatitis (MASH), presents a large opportunity for imaging and diagnostic devices.

The US FDA’s Center for Devices and Radiological Health is making key structural changes it says will help the center run more smoothly, including the addition of a new marketing and communications division.

The FDA has published final guidance to assist developers of medical devices designed to treat opioid use disorder, along with considerations for sponsors of clinical studies to evaluate those devices.

Last month, the US FDA increased the number of injuries and deaths initially reported in a March recall from Philips, which the company disputed. The FDA now says its adjusted numbers were in error.

A fiscal 2025 report from the US House Appropriations Committee instructs the FDA to halt implementation of its overhaul of LDT regulation. Members also showed concern about overseas device manufacturing and the availability of over-the-counter diagnostics. 

The US Federal Trade Commission wants to clean up the FDA’s Orange Book by purging medical device patents that the commission says should not be in the listing. The FTC argues improper patents in the Orange Book block lower-cost generic equivalents from coming to market. Medtech Insight spoke to attorney Sara Koblitz about the FTC’s delisting push.

This week, the US FDA authorized EUAs for at-home mpox tests and announced a public workshop on implanted brain devices; the IMDRF published guiding principles on good machine learning practices for AI; and Quest announced its deal to acquire a Canadian diagnostic firm.

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