With all of the changes sweeping through the FDA in this past year, many in the industry are asking questions and waiting for answers on what is to come.  Still, it is encouraging to see that there are a few opportunities where the public and the industry can get access to the process.  This is important, because the device makers actually want to be held accountable, and they also want a say in how regulations will be enforced.  The Agency has been asking for input on many of the new agenda items it is seeking to undertake.

First, since this is a blog we should mention the public hearings that took place just last November regarding how manufactures of FDA Regulated products use the internet and particularly social media.  Most of the discussion that took place over the 2-day hearing covered topics ranging for marketing claims and messages online, to post-market surveillance on social media websites.  Complete coverage of the events and industry reaction can be found on the FDASM website.  Many differing viewpoints still are being considered, and the FDA has yet to enact any formal polices or guidance as a result of these hearings.

Also, most recently the FDA has announced that it will hold a public meeting on Feb. 18 to review the premarket approval, or 510(k) process, used to review and clear medical devices for sale in the United States market.  The goal of the meeting will be to hear comments and questions regarding any pending actions that the Center for Devices and Radiological Health (CDRH) may consider taking to tighten the 510(k) process.  Those wishing to attend  the meeting in person will need to register by 5 p.m. on Feb. 12, 2010. The agency is also accepting written or electronic comments by March 5, 2010.  Other meetings and committee hearings on various topics are posted on the FDA website throughout the year.  Though it remains to be seen how much of the public and industry feedback will find its way into policy, opportunities to have a voice are available.

As a final thought, this newly founded blog and soon to launch social network will be taking comments and feedback to submit to the FDA on the 510(k) process.  In an upcoming panel discussion at the Medical Device Summit there will be an opportunity to give some feedback and suggestions to Heather Rosecrans, Director, 510(k) Staff, CDRH, FDA.  We are collecting these suggestions from the industry in many forms including direct messages on Twitter to @my510k, posts to the Beta my510k.com network site, and comments in this blog.  All feedback will be collated and submitted to FDA on behalf of the community.  Start today and take action to defend our industry.  Change is inevitable, but you can make a difference…just don’t miss the chance to have your voice heard.