Act emergency medical equipment

I read your part 5 10(k) about equipment. You are going to go to the market. We decided to refer to all the above equipment, which is roughly equivalent to the equipment before the interstate commerce. Before May 28th, 1976, you may make changes to medical devices, so you may be required by general control regulations in the market. Including the annual registration of listed equipment, good manufacturing practices, labeling, and prohibition of wrong labeling and description.

If you are divided into two categories 2 (performance standards) or 3, you can additionally control the impact regulations of existing major equipment, which can be found in the US federal regulations. Title, part 895. On 2 1, the Food and Government has established the US Food and Drug Administration to announce a further statement on the federal registration of your equipment. Note: This reply should inform you of any obligations submitted before listing, and it will not affect your health and safety behaviors, which may be controlled by radiation or other federal laws or regulations of 1968.

This letter will soon get you started to develop a correct description of your equipment. The US Food and Drug Administration has discovered a pre-correction device for solid equivalent equipment, and the result is your equipment and classification.

Allowing your equipment to go on the market does not mean that the Food and Drug Administration (FDA) approves your equipment, so you can't advertise or represent that your equipment or its label is FDA-approved to a great extent.