Expert: Consider Worst Case When Filing Device Changes
When deciding whether to submit a 30-day notice or PMA supplement for changes to a device, companies must consider worst-case scenarios and be prepared to provide the FDA with a reason for their decision, an expert says.
300 N. Washington St., Suite 200, Falls Church, VA 22046, USA.
Phone (703) 538-7600 - Fax (703) 538-7676 - Toll free (888) 838-5578.
Copyright by FDAnews. All rights reserved. Do not duplicate or redistribute in any form.