Other US Medical Device Regulations

Other applicable regulations and topics related to United States medical devices and manufacturers.
Forum FAQ Threads
Sam Lazzara
  • Sticky
12 Steps to FDA UDI (Unique Device Identification) Compliance (2013 - 2015)
2 3 4 5
Replies
45
Views
15,951
cmeby
Forum Discussion Threads
K
Letter to file vs Special 510 for additional accessory in orthopaedic kit
Replies
0
Views
27
KMac
Marcelo Antunes
Medical Device News FDA news 14-09-18 - Use of Voluntary Consensus Standards in Premarket Submissions
Replies
2
Views
171
yodon
Marcelo Antunes
Medical Device News FDA News - 03-10-18 - CDRH FY 2019 Proposed Guidance Development and Focused Retrospective Review of Final Guidance
Replies
0
Views
32
Marcelo Antunes
T
Unique Device Identifier Advice
Replies
0
Views
44
tsteele
Marcelo Antunes
Medical Device News FDA News - 26-09-18 - FDA Reveals Vision for the Transition to ISO 13485
Replies
0
Views
137
Marcelo Antunes
Marcelo Antunes
Medical Device News FDA News - 24-09-18 - CDRH Releases Collaborative Communities Toolkit
Replies
0
Views
94
Marcelo Antunes
Marcelo Antunes
Medical Device News FDA News - 14-09-18 - Benefit-Risk Factors to Consider for Substantial Equivalence
Replies
0
Views
95
Marcelo Antunes
Marcelo Antunes
Medical Device News FDA news - 17-09-18 - Agency's commitment to studying breast implant safety
Replies
0
Views
83
Marcelo Antunes
Marcelo Antunes
Medical Device News FDA news 14-09-18 - Recognition and Withdrawal of Voluntary Consensus Standards
Replies
0
Views
94
Marcelo Antunes
Marcelo Antunes
Medical Device News FDA - Eliminating Routine FDA news 14-09-18 - Re-Review of Third Party 510(k) Reviews
Replies
0
Views
94
Marcelo Antunes
You must log in or register to post here.
Top