Scrip is part of Pharma Intelligence UK Limited
This site is operated by Pharma Intelligence UK Limited, a company registered in England and Wales with company number 13787459 whose registered office is 5 Howick Place, London SW1P 1WG. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group.
This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183
Printed By
This article was originally published in RAJ Devices
The US Food and Drug Administration has issued a final rule that reclassifies certain software and hardware products used with medical devices as Class I or low-risk products1,2. Until now, these devices were considered to be either Class III (high-risk) devices requiring pre-market approval or accessories to an existing medical device.
| Table |
|---|
Ask the Analyst is free for subscribers. Submit your question and one of our analysts will be in touch.
Thank you for submitting your question. We will respond to you within 2 business days. my@email.address.
All fields are required.
All set! This article has been sent to my@email.address.
All fields are required. For multiple recipients, separate email addresses with a semicolon.
Please Note: Only individuals with an active subscription will be able to access the full article. All other readers will be directed to the abstract and would need to subscribe.
