Thanks! You've successfully subscribed to the BONEZONE®/OMTEC® Monthly eNewsletter!

Please take a moment to tell us more about yourself and help us keep unwanted emails out of your inbox.

Choose one or more mailing lists:
BONEZONE/OMTEC Monthly eNewsletter
OMTEC Conference Updates
Advertising/Sponsorship Opportunities
Exhibiting Opportunities
* Indicates a required field.

Articles Tagged "guidance document"

FDA Issues Direct Final Rule to Alter Outdated Requirements on Biologics Inspections

by BONEZONE | Feb 2018

The rule amends that inspections will be risk-based, not biennial.... Read more »

UDI Direct Marking Guidance Finalized by FDA

by BONEZONE | Nov 2017

FDA did not offer device companies new direction on methods to direct mark, as it would be difficult to account for the wide variety of existing devices, use conditions and reprocessing methods.... Read more »

A Look at FDA’s 2016 Priorities, Status of 2015 Priorities

by BONEZONE | Jan 2016

FDA released its annual priority list for the new year, as well as previously-issued final guidance documents, on which CDRH is accepting feedback as part of its retrospective review.... Read more »

New UDI Draft Guidance Addresses Direct Marking of Reprocessed Devices

by BONEZONE | Jul 2015

FDA’s most recent UDI draft guidance, Unique Device Identification: Direct Marking of Devices, addresses common questions posed by labelers preparing for the September 24, 2015 compliance deadline.... Read more »

GHX Announces UDI Solution

by BONEZONE | Jan 2014

Adaptive designs have emerged as an attractive alternative to traditional clinical studies due to the potential to reduce resources, time and costs. However, several critical components must be considered to determine whether such a trial design is a fit for you.... Read more »

FDA Publishes List of Priorities for 2014

by BONEZONE | Jan 2014

Adaptive designs have emerged as an attractive alternative to traditional clinical studies due to the potential to reduce resources, time and costs. However, several critical components must be considered to determine whether such a trial design is a fit for you.... Read more »

FDA Posts 510(k) Communication Timeline

by BONEZONE | Jan 2014

Adaptive designs have emerged as an attractive alternative to traditional clinical studies due to the potential to reduce resources, time and costs. However, several critical components must be considered to determine whether such a trial design is a fit for you.... Read more »