Eisner Safety Consultants

On November 8, 2011 FDA issued a notice in the Federal Register extending the public comment period for the draft Guidance Document “510(k) Device Modifications: Deciding When to Submit a 510(k) for a Change to an Existing Device” from October 25, 2011 to November 28, 2011. In the Federal Register Notice the FDA said “The [...]

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.

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 requirements for medical devices.

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 are appropriate for the approval pathway and when those applications would require additional evidence of [...]

How to comment on FDA CDRH FY11 Draft Guidance Documents?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 CDRH is considering for development this year (2011). CDRH plans to update this list every [...]