After the FDA has accepted a manufacturer’s premarket notification, if the agency requests additional information by telephone, fax, or letter, the manufacturer should either submit it within 30 days, or request an extension and state the time needed. When responding, identify the additional information with your company name and 510(k) number. If you submitted a 510(k) summary, include any updates to it. State where the information should be included in your application by referring to the topic, section, or page numbers.
Following this step-by-step submission process will help ensure rapid review of the 510(k) notification. However, submitters must stay abreast with the regulatory process. With the current emphasis on reengineering government, and future concerns about device safety and effectiveness, change will be the only constant.