Dear Manufacturer or Own-Label Distributor:

This is to alert you that your infant mattresses and/or infant positioners are medical devices subject to FDA jurisdiction if medical claims associated with Sudden Infant Death Syndrome (SIDS) are made in the labeling of these products. Because they are medical devices when such claims are made, these products may not be legally marketed without prior FDA review. Firms who make these products or distribute them under their own label are required to register their establishment and list their devices with FDA. These firms also are subject to FDA inspection to ensure that they comply with the medical device reporting requirements and appropriate good manufacturing practices. (see definitions below)

Here are some examples of medical claims that would cause an infant mattress or positioner to be considered a medical device:

"Reduce the risk of SIDS" "Helps prevent SIDS" "The danger of cot death can be eliminated…"

"To the extent that SIDS may be caused by a buildup of carbon dioxide in the crib mattress area, the…mattress may help reduce the risk of SIDS…"

"And while nothing is absolutely proven to prevent SIDS, this product may actually lower your baby’s risk." "…added safety and protection against Sudden Infant Death syndrome (SIDS)."

"…a dramatic decrease in the incidence of sudden infant crib syndrome…"

"If the mattress…is correctly wrapped…There is no risk of cot death"

"…helps to reduce one phenomenon called the "sink-hole" effects recently linked to SIDS"

If you currently have labeling that contains medical claims associated with SIDS such as those described above on any labeling of your infant mattresses and/or infant positioners, your product is subject to review by the Food and Drug Administration. If your product labeling does not contain such claims, or if you remove such claims from all your current labeling, you will not be considered a medical device manufacturer or own-label distributor and will not be required to make a premarket submission to FDA.

In order for you to legally market these infant products with medical claims associated with SIDS, you must demonstrate that your product is substantially equivalent to a legally marketed product making similar claims. Or you must independently establish that your product is safe and effective for the intended use associated with reducing, preventing, or eliminating SIDs. This evidence, demonstrating either substantial equivalence or safety and effectiveness, should be submitted to FDA through a Pre-market Notification [510(k)]or Pre-market Approval (PMA) application. Continued distribution without a 510(k) or PMA could result in FDA action.

We suggest that you review your current labeling, including any literature and internet advertising, to determine if you are making any medical claims associated with SIDS or any other medical condition or disease for your infant mattresses and/or infant positioners. After reviewing your current labeling, please advise us:

1. That your labeling does have medical claims associated with SIDS and describe the steps you are taking to change your labeling to remove the medical claims; OR
2. That your labeling does have medical claims associated with SIDS and you intend to continue marketing your products with these claims; OR
3. That your labeling does not make any medical claims associated with SIDS such as those examples described in this letter.

A written response to us will acknowledge that you have received this letter and have reviewed your labeling for medical claims associated with SIDS. Responses and copies of current and revised labeling can be sent to:

If you choose to market your infant mattresses and/or infant positioners with medical claims, you must submit a Pre-Market Notification [510(k)] application or PMA to FDA within sixty (60) days of receipt of this letter to:

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