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To amend the Federal Food, Drug, and Cosmetic Act to provide for the establishment of a third-party quality system assessment program for devices, and for other purposes.

USA115th CongressHR-2483| House 
| Updated: 5/19/2017
Richard Hudson

Richard Hudson

Republican Representative

North Carolina

Cosponsors (1)
Larry Bucshon (Republican)

Health Subcommittee, Energy and Commerce Committee

  • Introduced
  • In Committee
  • On Floor
  • Passed Chamber
  • Enacted
Quality Systems Certification Act of 2017 This bill amends the Federal Food, Drug, and Cosmetic Act to require the Food and Drug Administration (FDA) to establish a third-party quality system assessment program to accredit persons to assess whether a medical device manufacturer's quality system can ensure the safety and effectiveness or substantial equivalence of an approved medical device after certain changes, including changes in manufacturing or changes to enhance device safety. Device manufacturers with quality systems that have been certified by an accredited person are allowed to make changes to a device without submitting to the FDA the premarket notification, 30-day notice, or premarket approval supplement that would otherwise be required. An accredited person who assesses a device manufacturer's quality system must submit a summary of their assessment and, as appropriate, a certification of the quality system to the FDA within 30 days of the assessment. An assessment summary and certification is deemed accepted by the FDA 30 days after submission unless the FDA determines that additional information is needed to support certification, the assessment or certification is unwarranted, or an action other than acceptance of the certification is otherwise justified. Device manufacturers who make changes to devices without submitting a premarket notification must describe the changes in an annual summary submitted to the FDA. Changes made without submitting a 30-day notice or a premarket approval supplement must be described in a periodic report. Certifications accepted by the FDA remain in effect for two years. The FDA must report on this quality system assessment program no later than January 31, 2022. The program is terminated at the end of FY2022.
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Timeline
May 17, 2017
Introduced in House
May 17, 2017
Referred to the House Committee on Energy and Commerce.
May 19, 2017
Referred to the Subcommittee on Health.
  • May 17, 2017
    Introduced in House


  • May 17, 2017
    Referred to the House Committee on Energy and Commerce.


  • May 19, 2017
    Referred to the Subcommittee on Health.

Health

Related Bills

  • S 115-1183: A bill to establish a third-party quality system assessment program.
Administrative law and regulatory proceduresDepartment of Health and Human ServicesDrug safety, medical device, and laboratory regulationHealth technology, devices, suppliesProduct safety and quality

To amend the Federal Food, Drug, and Cosmetic Act to provide for the establishment of a third-party quality system assessment program for devices, and for other purposes.

USA115th CongressHR-2483| House 
| Updated: 5/19/2017
Quality Systems Certification Act of 2017 This bill amends the Federal Food, Drug, and Cosmetic Act to require the Food and Drug Administration (FDA) to establish a third-party quality system assessment program to accredit persons to assess whether a medical device manufacturer's quality system can ensure the safety and effectiveness or substantial equivalence of an approved medical device after certain changes, including changes in manufacturing or changes to enhance device safety. Device manufacturers with quality systems that have been certified by an accredited person are allowed to make changes to a device without submitting to the FDA the premarket notification, 30-day notice, or premarket approval supplement that would otherwise be required. An accredited person who assesses a device manufacturer's quality system must submit a summary of their assessment and, as appropriate, a certification of the quality system to the FDA within 30 days of the assessment. An assessment summary and certification is deemed accepted by the FDA 30 days after submission unless the FDA determines that additional information is needed to support certification, the assessment or certification is unwarranted, or an action other than acceptance of the certification is otherwise justified. Device manufacturers who make changes to devices without submitting a premarket notification must describe the changes in an annual summary submitted to the FDA. Changes made without submitting a 30-day notice or a premarket approval supplement must be described in a periodic report. Certifications accepted by the FDA remain in effect for two years. The FDA must report on this quality system assessment program no later than January 31, 2022. The program is terminated at the end of FY2022.
View Full Text

Suggested Questions

Get AI-generated questions to help you understand this bill better

Timeline
May 17, 2017
Introduced in House
May 17, 2017
Referred to the House Committee on Energy and Commerce.
May 19, 2017
Referred to the Subcommittee on Health.
  • May 17, 2017
    Introduced in House


  • May 17, 2017
    Referred to the House Committee on Energy and Commerce.


  • May 19, 2017
    Referred to the Subcommittee on Health.
Richard Hudson

Richard Hudson

Republican Representative

North Carolina

Cosponsors (1)
Larry Bucshon (Republican)

Health Subcommittee, Energy and Commerce Committee

Health

Related Bills

  • S 115-1183: A bill to establish a third-party quality system assessment program.
  • Introduced
  • In Committee
  • On Floor
  • Passed Chamber
  • Enacted
Administrative law and regulatory proceduresDepartment of Health and Human ServicesDrug safety, medical device, and laboratory regulationHealth technology, devices, suppliesProduct safety and quality