CALL FOR FDA STORIES

CALL FOR FDA STORIES

The FDA is still causing the industry problems, especially to the small manufacturer. These are some of the complaints: Long drawn out inspections; inspectors who over step their bounds; 510(k) reviews that appear to be inconsistent with the FDA guidelines; communication problems with the agency and what appears to be a lack of uniformity from investigator to investigator and region to region.

If you have had some of these problems and would like to have them expressed without giving up your identity well now is your chance. I would like to compile these stories into a letter to the FDA and Congress to let them know what is really happening to the industry so that these areas could be addressed and possibly even corrected.

So, if you have such a story and would like to be part of this campaign, email me your story. Please let me know if it would be alright to publish your story, without your identity of course, this way others would see that their problem is not just isolated to them but is an industry problem.

I look forward to hearing from you and hope that we could make some real changes to the way the FDA works.

Thanks for your participation.

Alan P. Schwartz