Safer program guidance

And this video is a great way for your young ones to learn all about it. With a little help from "Dr. And school doors stay open.

Safer, Smarter Schools The Louisiana Department of Health aims to support Louisiana schools by providing COVID testing options at no cost to any school in the state with the shared goal to keep schools open and prevent outbreaks of COVID amongst the last population to have access to vaccination those under 12 years.

The Safer Technologies Program STeP is a voluntary program for certain medical devices and device-led combination products that are reasonably expected to significantly improve the safety of currently available treatments or diagnostics that target an underlying disease or condition associated with morbidities and mortalities less serious than those eligible for the Breakthrough Devices Program.

Devices that are eligible for STeP, unlike those that are eligible for the Breakthrough Devices Program, may include devices that are intended to treat or diagnose diseases or conditions that are non-life-threatening or reasonably reversible.

The goal of STeP is to provide patients and healthcare providers with timely access to these medical devices by expediting their development, assessment, and review, while preserving the statutory standards for premarket approval, k clearance, and De Novo marketing authorization, consistent with the Agency's mission to protect and promote public health. The Safer Technologies Program is a collaborative program intended to help reduce the time it takes to develop and obtain marketing authorization for eligible devices.

It offers manufacturers an opportunity to interact with the FDA's experts through several different program options to efficiently address topics as they arise during the premarket review phase, which can help manufacturers receive feedback from the FDA in a timely way.

Manufacturers can also expect interactive and timely communications, early engagement on Data Development Plans, sprint discussions, and senior management engagement to support the program, as resources permit. Devices subject to premarket approval applications PMAs , premarket notification k or requests for De Novo classification are eligible for inclusion in STeP if both of the following eligibility factors are met:. To receive the most benefit from program participation, ideally a request seeking inclusion for a device in STeP will be sent prior to sending your marketing submission for example, premarket approval application PMA , premarket notification k , or De Novo classification request.

In addition to completing the referral form, inspectors are encouraged to take photos or make a simple sketch of anything they observe that raises their concern. They are also encouraged to contact EOHA staff if they have any questions about something they saw while on a child care inspection. Family child care homes providing care to six or fewer children in a private home are not a primary focus because private residential homes are less likely to be located on properties with a past industrial use or in buildings with a co-located industrial use.

Although the approaches used by the SAFER Program to find potential problem child cares are not routinely applied to family child care homes, inspectors understand that if they observe something of concern at a child care home, they can refer it for follow up.

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