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‘We Were A Victim’: How An FDA Remote Regulatory Assessment Took One Device Maker By Surprise

 
• By Shawn M. Schmitt

A manufacturer approached by the US FDA to participate in its voluntary Remote Regulatory Assessment program quickly discovered it bit off more than it could chew. It also didn’t help that the investigator running the firm’s RRA seemed to skirt agency protocol around the assessments. RRAs have taken the place of on-site facility inspections during the COVID-19 pandemic.

An Orb spider squirts venom and traps a ladybird enwrapping its victim in silk threads.
• Source: Alamy

[Editor’s note:To ensure its privacy, Medtech Insight will not name the manufacturer that’s the subject of this story.]

Consultant Korina Akhondzadeh was enjoying a quiet March vacation when she was interrupted by a frantic phone call from a...

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More from Compliance

Warning Letters - July 2025

The US FDA posted three warning letters in July, covering medical supply kits, wearables and orthopedics.

Survey Reveals Gaps In Medtech Compliance Processes

 
• By Elizabeth Orr

Medical device firms often have serious compliance gaps, a recent Veeva MedTech survey found. Only 50% of the companies surveyed are confident in their global registration data, with 70% reporting inconsistencies during audits. The report recommends automation and better data governance.

PathAI Talks PCCPs: ‘Accelerated Software Updates, Saves Time And Money’

 
• By Natasha Barrow

The US FDA has authorized around 107 devices with Predetermined Change Control Plans in place, with PathAI's AISight Dx digital pathology image management system one of the latest. Medtech Insight talks to Eric Walk, chief medical officer, to find out about the process and its benefits.

Global Medtech Guidance Tracker: July 2025

 
• By Vibha Sharma and Anabel Costa-Ferreira

Stay current on regulatory guidelines from around the world with Medtech Insight's Guidance Tracker. Over 40 documents have been posted on the tracker since its last update.

More from Policy & Regulation

Biden-Era Device Trial Snapshot Pilot Halted Amid DEI Policy Shift

 
• By Elizabeth Orr

The FDA's Device Clinical Trial Snapshot Pilot, aimed at increasing trial transparency and diversity, has been canceled following President Trump’s anti-DEI executive order. Critics warn this may hinder trial transparency, impacting public health and demographic data accessibility.

Warning Letters - July 2025

The US FDA posted three warning letters in July, covering medical supply kits, wearables and orthopedics.

Brazil’s Medtechs Look To Solutions After 50% US Tariff Hit Amid ‘Scenario Of Uncertainty’

 
• By Bernard Murphy

Hopes that last-minute negotiations might exempt Brazil’s $300m medtech exports from the latest round of US tariffs have been dashed, leaving the industry braced for further market instability that countermeasures could trigger.