On November 8, 2011 FDA issued a notice in the Federal Register extending the public comment period for the draft Guidance Document “510(k) Device Modifications: Deciding When to Submit a 510(k) for a Change to an Existing Device” from October
FDA Updates 515 Prog. Initiative Webpage (reclassified preAmend Class III 510(k)s)
The FDA updated the 515 program initiative webpage also known as reclassification of preAmendment Class III 510(k)s. Currently there are 26 Class III products going thru the 515 program initiative and you can view the status of the 515 project.
FDA Modifications to List of Recognized Standards, List 025
On Oct 4, 2010 the Federal Register published the “Modifications to the List of Recognized Standards, Recognition List Number: 025“. This list will assist medical device manufacturers who elect to declare conformity with FDA Consensus Standards to meet certain FDA
Stricter 510(k) Process Offers Challenges, Promises
From MDDI Magazine – Sept 2010 – “FDA has released its long-awaited plans to shore up the 510(k) clearance system used to get many medical devices to market. In August, the agency published a 120-page report to define which devices
How Comment on FDA CDRH FY11 Draft Guidance Documents?
How to comment on FDA CDRH FY11 Draft Guidance Documents? http://ht.ly/2OiXg From the FDA CDRH webpage titled “Documents the CDRH is Considering for Development (FY11)” the following is the intoduction to the page: “This is the list of guidance documents