Welcome to our new website! If this is the first time you are logging in on the new site, you will need to reset your password. Please contact us at raps@raps.org if you need assistance.
Your membership opens the door to free learning resources on demand. Check out the Member Knowledge Center for free webcasts, publications and online courses.
Hear from leaders around the globe as they share insights about their experiences and lessons learned throughout their certification journey.
Posted 06 September 2017 | By Zachary Brennan
About a week after the US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) was criticized for sending a historically low number of warning letters so far in 2017, a flood of new letters were released Wednesday.
The warning letters were sent from February through August 2017 to three manufacturers from the US, and five in Brazil, the Netherlands, Germany, China and Bulgaria.
The release of the letters follows a story in Bloomberg News highlighting that CDRH had only previously released one warning letter in 2017, which was a fraction of the number issued in previous years.
In the US, CDRH warned Boston-based SyncThink in July for marketing an eye impairment device without clearance or approval.
Henderson, Nevada-based Steiner Biotechnology also received a warning letter for not complying with federal regulations while conducting clinical studies for two products, known as Ridge Graft and Skeletal Graft.
And Plymouth, Minnesota-based Entellus Medical received a warning letter in April for deviating from clinical trial protocols in a study of a multi-sinus dilation system.
“At multiple clinical sites, Entellus Medical clinical personnel were present during procedures that included protocol deviations consisting of use of the device on the frontal and sphenoid sinuses of pediatric subjects under the age of 12,” the letter says.
CDRH also sent a warning letter to Brazil-based MB Industria Cirurgica Ltda on 4 August, with 10 observations related to the company’s failures in manufacturing wound dressings. Netherlands-based QLRAD received a warning letter in July for marketing the RectalPro Endorectal Balloon (ERB) in the US without marketing clearance or approval.
China-based Hebei Pukang Medical Instruments Co., Ltd. received a warning letter in March for its failures in manufacturing AC-powered adjustable beds, wheeled stretchers, manual beds, cabinet trays and operating room table and attachments.
Sofia, Bulgaria-based X12, meanwhile, received a warning letter sent in March for manufacturing adulterated sterile reflective marker spheres.
And Berlin-based G L E Gesellschaft für lichttechnische Erzeugnisse GmbH received a warning letter in February
SyncThink, Inc. 7/31/17
Steiner Laboratories 6/21/17
Entellus Medical 4/6/17
MB Industria Cirurgica Ltda 8/4/17
HOSPIMED 7/20/17
Hebei Pukang Medical Instruments Co., Ltd. 3/29/17
X12 Co., LTD. 3/23/17
G L E Gesellschaft Fur Lichttechnische Erzeugnisse Mbh 2/23/17
Tags: warning letters, medical device warnings
Regulatory Focus newsletters
All the biggest regulatory news and happenings.