The American Association for Homecare last week announced support for the Medical Gases Safety Act, a measure that would improve the regulation of medical gases by allowing the FDA to establish rules outside the New Drug Application (NDA) process.
The act is included in the Food and Drug Administration (FDA) user fee reauthorization bills that are now working their way through Congress.
Under the NDA process, medical gases are supposed to be regulated similar to pharmaceutical drugs. However, the FDA has acknowledged that the NDA process is inappropriate for gases and has not enforced the regulation.
House and Senate versions of the FDA reauthorization bill would create unique regulations for medical gases to better account for their use and safety, AAHomecare said.
In letters sent last week, AAHomecare told the House Energy and Commerce Committee and Senate Health, Education, Labor and Pensions Committee that including the medical gases provision in their bills made sense.
