Alcohol, Tobacco, Firearms, and Explosives Bureau August 18, 2015 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA) is classifying the esophageal thermal regulation device into class II (special controls). The special controls that will apply to the device are identified in this order and will be part of the codified language for the esophageal thermal regulation device's classification. The Agency is classifying the device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a document entitled ``Providing Submissions in Electronic FormatPostmarketing Safety Reports for Vaccines; Guidance for Industry.'' The guidance document provides information and recommendations pertaining to the electronic submission of postmarketing safety reports involving vaccine products marketed for human use with approved biologics license applications (BLAs), including individual case safety reports (ICSRs) and attachments to ICSRs (ICSR attachments), into the Vaccine Adverse Event Reporting System (VAERS). VAERS is a national vaccine safety surveillance program that is co-sponsored by the Centers for Disease Control and Prevention (CDC) and FDA. FDA published in the Federal Register a final rule requiring that certain postmarketing safety reports for human drug and biological products, including vaccines, be submitted to FDA in an electronic format that the Agency can process, review, and archive. The guidance is intended to help applicants required to submit postmarketing safety reports involving vaccine products to comply with the final rule. The guidance announced in this notice finalizes the draft guidance of the same title, dated July 2014, and supersedes the document entitled ``Guidance for Industry: How to Complete the Vaccine Adverse Event Report System Form (VAERS-1)'' dated September 1998.

The Food and Drug Administration (FDA) is announcing the availability of the guidance entitled ``Select Updates for Non-Clinical Engineering Tests and Recommended Labeling for Intravascular Stents and Associated Delivery Systems.'' FDA has developed this guidance to inform the coronary and peripheral stent industry about selected updates to FDA's thinking regarding certain non-clinical testing for these devices. While FDA is considering more substantial updates to the ``Non-Clinical Engineering Tests and Recommended Labeling for Intravascular Stents and Associated Delivery Systems'' guidance (http:/ /www.fda.gov/medicaldevices/deviceregulationandguidance/ guidancedocuments/ucm071863.htm), we are issuing this update on select sections in order to notify the industry in a timely manner of our revised recommendations.