The Food & Drug Administration’s Center for Devices and Radiological Health established a website to aid the the industry in understanding the Center’s Kafka-esque approval process.
The site, called CDRH Learn, consists of training modules designed to educate the public on pre-market and post-market medical device and radiological health regulation. The resource includes video presentations and an exam to assess each user’s knowledge of approval processes.
According to an FDA email, the website "is intended to educate industry on CDRH’s requirements for manufacturing and/or marketing [medical and radiological devices]."
The branch of the FDA dedicated to regulating medical devices has been catching a lot of flack lately for sluggish bureaucratic process and poor communication with applicants to its 510(k) and PMA processes.
The CDRH has been pouring a lot of resources into creating a more transparent and predictable review process for medical devices. The agency will release results from an internal, soup-to-nuts review of its 510(k) clearance program in a few weeks. The agency invited the public to leave comments on its website regarding PMA issues until August 9. And it tapped the Institute of Medicine for a $1.3 million external review of the 510(k) process, due to be competed next year.