Federal Register Notice: FDA is making available a draft guidance for industry, Certification Process for Designated Medical Gases. It describes the new certification process created by the FDA Safety and Innovation Act for certain medical gases and explains how FDA plans to implement that process. It describes the medical gases that are eligible for certification, who should submit a certification request, what information should be submitted, and how FDA will evaluate and act on the request. The draft guidance also describes how the new certification requirement will be enforced and describes FDA’s intent to exercise enforcement discretion in certain instances. The agency has also developed a form to help requestors submit their certification requests and recommends that requestors use this form. To download this guidance, click here. To view this notice, click here.