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FDA Issues Work Plan For Independent Assessment Of Pre-market Review Process

The assessment, called for by industry during the device user fee reauthorization, will be conducted by an independent consulting firm. The goal is to identify efficiencies in the device review process.

FDA is preparing to have a private, independent consulting firm assess its management of the device pre-market review process. On Dec. 19, the agency issued a statement of work plan for the assessment and opened a 30-day comment period to obtain industry feedback.

It was the device industry that originally called for the assessment, gaining FDA's promise to take the step during negotiations over this year's user fee reauthorization. The assessment will be conducted in two phases, with the first contract to be awarded by mid-2013, according to the MDUFA III commitment letter between industry and FDA

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FDA Announces Classifications On 8 Device Types

 
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• By Marion Webb

Global investment in consumer healthtech increased by 9% year-over-year in 2024, totaling $4.5bn, with significant interest in mental health solutions, according to Galen Growth. While the first quarter of 2025 saw raised confidence and investments, the Trump administration’s new tariffs and sweeping changes to healthcare have introduced new uncertainties.

More from Policy & Regulation

FDA Announces Classifications On 8 Device Types

 
• By Elizabeth Orr

The US Food and Drug Administration has announced new classifications for eight device types that reached market via the de novo process, with most of the newly classified products in the diagnostics sector.

Medical Devices Not The Focus Of FDA’s Plans To Step Up Foreign Inspections, Expert Says

 
• By Brian Bossetta

The US FDA recently announced plans to carry out more unannounced inspections of foreign facilities. But those inspections will primarily target drug producers, with less attention and resources allocated to those making devices.

State And International Enforcement Agencies May Step Up Amid Uncertain Federal Environment

 
• By Elizabeth Orr

States and international regulatory bodies may increase their US enforcement role following federal staff cuts, Hyman Phelps & McNamara attorneys said in a recent webinar. The attorneys also expect False Claims Act enforcement and public health to remain key areas of focus at the federal level.