Note: Before making documents available to the public, FDA must redact trade secret and confidential commercial information (CCI) and ensure documents posted to the FDA website are accessible to everyone. For these reasons, the full decision summary, environmental assessment and finding of no significant impact (FONSI) memo for marketing authorizations may be posted to the website after the order issuance date. In the interim, to provide as much information as possible at the time of order issuance, we are making redacted versions of the order letter and the “Executive Summary” section of the decision summary available to broadly explain the public health rationale for authorization of these products.
*The product categories listed in this chart only reflect FDA’s categorization for the purposes of premarket review. Some products may fit in one category for the purposes of premarket review but may come under different product category definitions by statute and regulation, and thus may be subject to different or additional requirements than the category indicated in the chart.