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To direct the Secretary of Health and Human Services, acting through the Commissioner of Food and Drugs, to promulgate rules to update certain regulations relating to human cells, tissues, and cellular and tissue-based products, and for other purposes.

12/29/2022, 9:48 PM

Summary of Bill HR 6948

Bill 117 hr 6948, also known as the "Human Cells, Tissues, and Cellular and Tissue-Based Products Regulation Update Act," aims to direct the Secretary of Health and Human Services to update regulations pertaining to human cells, tissues, and cellular and tissue-based products. The bill specifically tasks the Commissioner of Food and Drugs with promulgating rules to modernize and improve existing regulations in this area.

The purpose of this legislation is to ensure that regulations governing the use of human cells, tissues, and cellular and tissue-based products are up-to-date and reflective of current scientific advancements and best practices. By updating these regulations, the bill seeks to enhance the safety, efficacy, and quality of these products, ultimately benefiting patients who rely on them for medical treatment.

In addition to updating regulations, the bill may also include provisions aimed at improving oversight, enforcement, and transparency in the regulation of human cells, tissues, and cellular and tissue-based products. These measures are intended to strengthen the regulatory framework governing these products and ensure that they meet the highest standards of safety and quality. Overall, Bill 117 hr 6948 represents a bipartisan effort to modernize and improve regulations related to human cells, tissues, and cellular and tissue-based products, with the ultimate goal of enhancing patient safety and access to innovative medical treatments.

Congressional Summary of HR 6948

This bill requires the Food and Drug Administration to update its regulations relating to the manufacture of human cells, tissue, and cellular and tissue-based products (HCT/Ps), including an update to the definition of minimal manipulation. (The regulations are commonly referred to as the tissue rules; HCT/Ps that are minimally manipulated and meet other criteria are not regulated as drugs, devices, or biologics and therefore are not subject to premarket review.)

Current Status of Bill HR 6948

Bill HR 6948 is currently in the status of Bill Introduced since March 7, 2022. Bill HR 6948 was introduced during Congress 117 and was introduced to the House on March 7, 2022.  Bill HR 6948's most recent activity was Referred to the Subcommittee on Health. as of March 8, 2022

Bipartisan Support of Bill HR 6948

Total Number of Sponsors
1
Democrat Sponsors
0
Republican Sponsors
1
Unaffiliated Sponsors
0
Total Number of Cosponsors
2
Democrat Cosponsors
0
Republican Cosponsors
2
Unaffiliated Cosponsors
0

Policy Area and Potential Impact of Bill HR 6948

Primary Policy Focus

Health

Alternate Title(s) of Bill HR 6948

To direct the Secretary of Health and Human Services, acting through the Commissioner of Food and Drugs, to promulgate rules to update certain regulations relating to human cells, tissues, and cellular and tissue-based products, and for other purposes.
To direct the Secretary of Health and Human Services, acting through the Commissioner of Food and Drugs, to promulgate rules to update certain regulations relating to human cells, tissues, and cellular and tissue-based products, and for other purposes.

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