FDA Announces Least Burdensome Provisions Draft Guidance

1/17/18

FDA Announces Least Burdensome Provisions Draft Guidance to Modernize Medical Device Approval

Background:

  • Current regulations for medical device marketing approval in the United States were enacted more than 40 years ago.
  • One pathway – 510(k) – requires medical device manufacturers to provide evidence that their product is substantially equivalent to a predicate device, or one that was marketed prior to 1976.
  • Modern medical devices are more technologically advanced than 40 years ago due to differences from predicate devices and may be subject to a Premarket Approval, which requires a longer, more complicated and costly process to gain marketing approval.
  • The FDA Modernization Act of 1997 (FDAMA) initiated the least burdensome approach for medical device premarket evaluation.
  •  21st Century Cures Act of 2016 expanded the least burdensome requirement in order to expedite the review of medical devices.
    • The FDA gained the ability remove the 501(k) approval requirement for some lower risk devices.

New Draft Guidance Document Announcement:

  • In an effort to streamline the regulatory requirements and burdens while maintaining safe and effective medical devices, the FDA has released “The Least Burdensome Provisions: 2 Concept and Principles” Draft Guidance.
  • The Draft Guidance explains how the FDA intends to implement the least burdensome provisions enacted by Congress.
  • Draft provisions include:
    • Requesting the minimum amount of information required to make a decision be submitted by the sponsor.
    • Requesting information submitted by sponsor be clear, concise, and relevant.
    • Review customized for the type of medical device and potential patient needs.
  • Expected Improvements (source):
    • Reduced time and cost burdens while maintaining safety and effectiveness during development of quality medical devices.
    • Faster access to potentially life-saving medical devices.
    • Ability to implement a risk-based approach to compliance policies.
    • Frees up FDA resources for higher priority public health matters.
    • Ability to use data generated during routine clinical care.
    • Use of computer models to improve medical device review.
    • Determination of a benefit-risk profile for medical devices.

International Effects:

  • The United States has lead the way in international harmonization of medical device approval where the current regulations are less efficient and create undue burden.
  • The FDA is a founding member of the International Medical Device Regulators Forum and participated in a Working Group for the Medical Device Single Audit Program, which aims to streamline medical device approval in participating countries.

The new Draft Guidance attempts to modernizes the device regulatory pathway by reducing undue burdens on the device manufacturer and the FDA, and through the use of new evaluation tools through the least burdensome provisions, medical devices remain high quality, safe and effective and are streamlined through marketing approval. This draft guidance was posted December 15, 2017 and the comment period lasts 60 days. 

The draft can be found here.

- The Clinical Pathways Team 

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