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  5. A History of Medical Device Regulation & Oversight in the United States
  1. Overview of Device Regulation

A History of Medical Device Regulation & Oversight in the United States

The Food and Drug Administration (FDA) is the oldest comprehensive consumer protection agency in the United States. The FDA’s oversight of food and drugs began in 1906 when President Theodore Roosevelt signed the Pure Food and Drugs Act. Since then, Congress has expanded the FDA’s role in protecting and promoting the development of human and veterinary drugs, biological products, medical devices and radiation-emitting products, human and animal food, and cosmetics.

In the 1960s and 1970s, Congress responded to the public’s desire for more oversight over medical devices by passing the Medical Device Amendments to the Federal Food, Drug, and Cosmetic Act. In 1982, the organizational units at the FDA that regulated medical devices and radiation-emitting products merged to form the Center for Devices and Radiological Health (CDRH).

The chronology below highlights milestones in the history of medical device legislation in the United States. For additional details, please see the text of the individual Acts.

1906: Pure Food and Drugs Act (sometimes also called the Federal Food and Drugs Act)
  • Established the precursor to today’s FDA
  • Prohibited interstate commerce of misbranded and adulterated food, and drugs
1938: Federal Food, Drug, and Cosmetic Act (FD&C Act)
  • Primary statute that authorizes the FDA’s regulation and oversight of medical products
  • Extended prohibition of interstate commerce to misbranded and adulterated cosmetics and therapeutic medical devices
  • Authority for factory inspections
1944: Public Health Service Act
  • Established certification of laboratories
  • Expanded oversight of biologics
1968: Radiation Control for Health and Safety Act
  • Intended to minimize exposure to electronic product radiation and intense magnetic fields
  • Created performance standards for radiation-emitting products, such as diagnostic x-ray machines, MRIs, microwave, ultrasound or diathermy devices, UV devices and laser devices
1970: President Nixon established the Cooper Committee
  • Chaired by Theodore Cooper, M.D. (then director of the National Heart and Lung Institute) to study the need for medical device legislation
  • Recommended that any new legislation be specifically targeted to the devices because devices present different issues than drugs
  • Introduced concept of risk-based classifications for medical devices
1976: Medical Device Amendments to the FD&C Act
  • Intended to provide reasonable assurance of the safety and effectiveness of medical devices
  • Created a three-class, risk-based classification system for all medical devices
  • Established the regulatory pathways for new medical devices (devices that were not on the market prior to May 28, 1976, or had been significantly modified) to get to market: Premarket Approval (PMA) and premarket notification (510(k))
  • Created the regulatory pathway for new investigational medical devices to be studied in patients (Investigational Device Exemption (IDE))
  • Established several key postmarket requirements: registration of establishments and listing of devices with the FDA, Good Manufacturing Practices (GMPs), and reporting of adverse events involving medical devices
  • Authorized the FDA to ban devices
1977: The Bureau of Medical Devices and Diagnostic Products was renamed the Bureau of Medical Devices
1990: Safe Medical Devices Act (SMDA)
  • Improved postmarket surveillance of devices by:
    • Requiring user facilities such as hospitals and nursing homes to report adverse events involving medical devices
    • Authorizing the FDA to require manufacturers to perform postmarket surveillance on permanently implanted devices if permanent harm or death could result from device failure
  • Authorized the FDA to order device recalls and to impose civil penalties for violations of the FD&C Act
  • Defined substantial equivalence (the standard for marketing a device through the 510(k) program)
  • Modified procedures for the establishment, amendment, or revocation of performance standards
  • Created the Humanitarian Use Device (HUD)/Humanitarian Device Exemption (HDE) programs to encourage development of devices targeting rare diseases
1992: Mammography Quality Standards Act (MQSA)
  • Required mammography facilities to be accredited and federally certified as meeting quality standards
    • After initial certification, facilities must pass annual inspections by federal or state inspectors
1997: Food and Drug Administration Modernization Act (FDAMA)
  • Created the “least burdensome” provisions for premarket review
  • Created the option of accredited third parties to conduct initial premarket reviews for certain devices
  • Permitted the use of data from studies of earlier versions of a device in premarket submissions for new versions of the device
  • Provided for expanded access to investigational devices
  • Established the De Novo program through which novel low-to-moderate risk devices could be classified into Class I or II instead of automatically classifying them into Class III
2002: Medical Device User Fee and Modernization Act (MDUFMA)
  • Granted the FDA the authority to collect user fees for select medical device premarket submissions to help the FDA improve efficiency, quality, and predictability of medical device submission reviews
  • Enacted the Small Business Determination (SBD) program to permit reduced premarket approval fees for qualifying small businesses
  • Created FDA performance goals for decisions on certain premarket submissions
  • Established new regulatory requirements for ‘reprocessed’ devices
  • Authorized electronic registration of medical device firms
  • Established the Office of Combination Products
2007: Food and Drug Administration Amendments Act (FDAAA)
  • Reauthorized the medical device user fee (MDUFA II), including improvements to premarket review times
  • Required that all registration and listing be performed electronically
  • Required the FDA to establish a unique device identification (UDI) system for medical devices to require device labels to bear a unique identifier
2012: Food and Drug Administration Safety and Innovation Act (FDASIA)
  • Reauthorized the medical device user fee program (MDUFA III), including improvements to premarket review times and added shared outcome goals with industry
  • Created direct De Novo pathway, permitting the classification of novel, low-to-moderate risk devices into Class I or II (rather than Class III) without first having to submit a 510(k)
  • Changed the standards associated with disapproval of an IDE
  • Permitted the FDA to work with foreign governments to harmonize regulatory requirements
  • Required FDA to provide a Substantive Summary when requested by the holder of the submission for significant decisions
  • Expanded the application of the “least burdensome” principles in premarket reviews
2016: 21st Century Cures Act
  • Mandated the creation or revision of policies and processes intended to speed patient access to new medical devices, including:
    • Codifying into law the FDA’s expedited review program for breakthrough devices
    • Expanding the application of the “least burdensome” principles in premarket reviews
    • Streamlining processes for exempting devices from the premarket notification (510(k)) requirement
    • Increasing the population estimate required to qualify for Humanitarian Use Device (HUD) designation from "fewer than 4,000" to "not more than 8,000” patients in the U.S. per year
    • Permitting the use of central Institutional Review Board (IRB) oversight rather than requiring only local IRBs for IDE and HDE activities
    • Requiring the FDA to revise the regulation of combination products
    • Codifying into law a process for submitting requests for recognition/non-recognition of a standard
  • Clarified how certain digital health products can be regulated by defining the categories of medical software that can and cannot be regulated as devices
2017: Food and Drug Administration Reauthorization Act (FDARA)
  • Reauthorized the medical device user fee program (MDUFA IV), including improvements to premarket review times and investments in strategic initiatives like the National Evaluation System for health Technology (NEST) and patient input
  • Authorized risk-based inspection scheduling for device establishments and prescribed other process improvements related to device establishment inspections
  • Decoupled accessory classification from classification of the parent device
  • Required the FDA to conduct at least one pilot project to explore how real-world evidence can improve postmarket surveillance
2020: Coronavirus Aid, Relief, and Economic Security Act (CARES Act)
  • Enhanced FDA’s ability to identify, prevent, and mitigate possible shortages of medical product supply chains by requiring manufacturers of certain devices to submit notifications to FDA of an interruption or permanent discontinuance in manufacturing during or in advance of a public health emergency.
  • Clarified that the FDA may issue certification for devices manufactured in a foreign device establishment and shipped to another country
2022: FDA User Fee Reauthorization Act of 2022 (FDAUFRA)
  • Reauthorized the medical device user fee program (MDUFA V), including process  improvements and performance goals for premarket activities such as pre-submissions and investments in strategic initiatives like patient science and engagement and international harmonization efforts
  • Established new fee adjustments in later years of MDUFA V based on meeting performance goals and hiring benchmarks
  • Set a 13-week cap on the MDUFA carryover balance and separately funded a new Total Product Life Cycle (TPLC) Advisory Program (TAP) pilot
2022: Food and Drug Omnibus Reform Act of 2022 (FDORA)
  • Enhanced oversight of device establishments, including new authority to conduct remote regulatory audits and to inspect facilities that conduct research on devices
  • Provided the FDA with express authority to approve or clear devices with a predetermined change control plan (PCCP) 
  • Required that information about cybersecurity be provided in premarket submissions for certain devices (referred to as cyber devices) and that sponsors of such devices must ensure their cybersecurity 
  • Clarified that the FDA can ban devices for one or more intended use, and that banned devices ae not legally marketed devices
  • Required sponsors of certain device clinical studies to submit a diversity action plan with enrollment goals and plans to meet these goals beginning 180 days after the FDA issues final guidance on the subject
  • Permitted certification for devices manufactured in a foreign device establishment and shipped to another country provided the same device is also marketed in the United States and other criteria are met
  • Established a new registration fee waiver for small businesses experiencing financial hardship beginning in FY 2025
2022: Preparing for and Responding to Existing Viruses, Emerging New Threats, and Pandemics Act (PREVENT Pandemics Act)
  • Imposed steeper penalties for counterfeit devices
  • Clarified that the FDA may receive voluntary device shortage notifications outside of a public health emergency and directed the Agency to create a list of device types subject to mandatory notifications 
  • Clarified that the FDA may rely on qualified third parties to review requests for emergency use authorizations (EUAs) for in vitro diagnostic devices

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