To amend the Federal Food, Drug, and Cosmetic Act to reauthorize the authority to grant certain exemptions, and for other purposes.

12/29/2022, 11:48 PM

This bill reauthorizes through FY2027 (1) the Humanitarian Device Exemption Program (a specialized regulatory pathway for medical devices used to treat or diagnose diseases or conditions that affect no more than 8,000 individuals), and (2) the Pediatric Device Consortia Grants Program (a program that supports the development of medical devices for pediatric patients through nonprofit consortia).

Bill 117 hr 7679, also known as the "FDA Exemptions Reauthorization Act," aims to amend the Federal Food, Drug, and Cosmetic Act in order to extend the authority to grant certain exemptions. The bill seeks to reauthorize the ability to grant exemptions for specific products or substances that may not meet all the requirements outlined in the Act.

The main purpose of this bill is to ensure that the Food and Drug Administration (FDA) has the flexibility to grant exemptions when necessary, in order to promote innovation and access to new products while still maintaining safety and efficacy standards. This reauthorization is important for industries that rely on exemptions to bring new products to market, such as medical devices or certain food additives.

Overall, the bill is focused on balancing the need for regulatory oversight with the need for flexibility and innovation in the marketplace. It is intended to support the FDA in its mission to protect public health while also fostering growth and development in industries regulated by the Act.
Congress
117

Number
HR - 7679

Introduced on
2022-05-06

# Amendments
0

Sponsors
+5

Cosponsors
+5

Variations and Revisions

5/6/2022

Status of Legislation

Bill Introduced
Introduced to House
House to Vote
Introduced to Senate
Senate to Vote

Purpose and Summary

This bill reauthorizes through FY2027 (1) the Humanitarian Device Exemption Program (a specialized regulatory pathway for medical devices used to treat or diagnose diseases or conditions that affect no more than 8,000 individuals), and (2) the Pediatric Device Consortia Grants Program (a program that supports the development of medical devices for pediatric patients through nonprofit consortia).

Bill 117 hr 7679, also known as the "FDA Exemptions Reauthorization Act," aims to amend the Federal Food, Drug, and Cosmetic Act in order to extend the authority to grant certain exemptions. The bill seeks to reauthorize the ability to grant exemptions for specific products or substances that may not meet all the requirements outlined in the Act.

The main purpose of this bill is to ensure that the Food and Drug Administration (FDA) has the flexibility to grant exemptions when necessary, in order to promote innovation and access to new products while still maintaining safety and efficacy standards. This reauthorization is important for industries that rely on exemptions to bring new products to market, such as medical devices or certain food additives.

Overall, the bill is focused on balancing the need for regulatory oversight with the need for flexibility and innovation in the marketplace. It is intended to support the FDA in its mission to protect public health while also fostering growth and development in industries regulated by the Act.
Alternative Names
Official Title as IntroducedTo amend the Federal Food, Drug, and Cosmetic Act to reauthorize the authority to grant certain exemptions, and for other purposes.

Policy Areas
Health

Comments

Recent Activity

Latest Summary9/20/2022

This bill reauthorizes through FY2027 (1) the Humanitarian Device Exemption Program (a specialized regulatory pathway for medical devices used to treat or diagnose diseases or conditions that affect no more than 8,000 individuals), and (2) the Pe...


Latest Action5/6/2022
Referred to the House Committee on Energy and Commerce.