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].”
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MassDevice Staff Website The Massachusetts Medical Devices Journal is the online journal of the medical devices industry in the Commonwealth and New England, providing day-to-day coverage of the devices that save lives, the people behind them, and the burgeoning trends and developments within the industry.
The branch of the FDA dedicated to regulating medical devices has been catching a lot of flacklately 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.
A Deep-dive Into Specialty Pharma
A specialty drug is a class of prescription medications used to treat complex, chronic or rare medical conditions. Although this classification was originally intended to define the treatment of rare, also termed “orphan” diseases, affecting fewer than 200,000 people in the US, more recently, specialty drugs have emerged as the cornerstone of treatment for chronic and complex diseases such as cancer, autoimmune conditions, diabetes, hepatitis C, and HIV/AIDS.
The Massachusetts Medical Devices Journal is the online journal of the medical devices industry in the Commonwealth and New England, providing day-to-day coverage of the devices that save lives, the people behind them, and the burgeoning trends and developments within the industry.
