Podcast: FDA’s Inspection ‘Program Alignment,’ New Guidance Docs Top QA/RA Hotspots In 2017
• By Shawn M. Schmitt
US FDA has reportedly selected three cities that will be home to new agency divisions dedicated to coordinating inspections of device manufacturers under its “program alignment” inspection initiative. This development is just one of many that will touch quality and regulatory professionals this year, longtime industry insider Steve Niedelman says in this Medtech Insight podcast. Other topics to watch: FDA’s recent string of new guidances; the 21st Century Cures Act.
The US FDA has launched the Regulatory Accelerator to expedite digital health product development. This includes resources like a Resource Index for Innovators, a Medical Device Software Guidance Navigator, and best practices for early meetings.
The exemption, which President Donald Trump announced on July 17, is intended to cut the risk of critical device shortages. Stakeholders say the technology needed to cut emissions to required levels is not yet widely available.
Dexcom has recalled several models of its glucose monitoring receivers due to a speaker glitch that may suppress vital blood sugar alerts. The FDA designated the recall, which affects thousands of devices, as class I.
A recent JAMA column called for the US FDA to create an online database of medical device labeling, arguing that the move would increase transparency and help researchers, among other benefits. Medtech Insight discussed the idea with the paper’s lead author.
Steve Bates, head of the UK BioIndustry Association, has been appointed executive chair of the government’s Office for Life Sciences as the UK restructures its life sciences approach and drives health outcomes with a new NHS Long-Term Care plan.
The UK government’s response to MHRA public consultation on risk proportionate device routes to market and physical UKCA markings adds momentum to drive for modern, agile system. Another consultation in late 2025 will propose indefinite recognition of CE-marked devices in Great Britain.