< Back to Blog Home
Sign up to our Newsletter
Search Our Blog
-
Recent Posts
Categories
Recent Comments
Archives
US Quality & Regulatory
Are you looking to sell your Medical Device into the US?
If so, there are some important regulations you need to know.
Medilink East Midlands are holding a 1 day training …
Posted in Medical Device Consultancy, Training, US Quality & Regulatory
Tagged 510(k), FDA, FDA registration, medical device training, Medilink
1 Comment
FDA formally recognises AAMI’s Human Factors standards
FDA has now formally recognised the following AAMI human factors standards:
- AAMI / ANSI HE74-2001, Human factors design process for
…
FDA reclassify certain Percutaneous Transluminal Coronary Angioplasty (PTCA) catheters
21 CFR part 870 (CARDIOVASCULAR DEVICES) has been amended to reclassify PTCA catheters as described in 21 CFR 870.5100 (a). as …
Posted in Medical Device Consultancy, US Quality & Regulatory
Tagged Class II, Class III, FDA, medical devices, reclassification
Leave a comment
CDRH/FDA Public Webinar Tuesday 31st August
The Center for Devices and Radiological Health/US Food and Drug Administration will be holding a free webinar on the ‘FDA …
Posted in Medical Device Consultancy, US Quality & Regulatory
Tagged 510(k), CDRH, FDA
Leave a comment
FDA Issues Assessments of the 510(k) Program and Use of Science in Decision-Making
The U.S. Food and Drug Administration today issued two comprehensive evaluations containing recommendations that address three key objectives of the …
FDA publishes warning letter citing education, background and training as failures
It is uncommon for FDA the issue a warning letter in this area, and should (as with all warning letters) …
Unique Device Identification for Medical Devices in the US?
Pressure is being placed onto the FDA to come up with a UDI in order to track medical devices and improve …
