Quality Systems Certification Act of 2017

[AI summary unavailable — showing source text] 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 un…