21st Century Cures Act reforms to the Food and Drug Administration’s (FDA) regulation of the medical device and pharmaceutical industries – Medical Device Overview: Major FDA Reform Bill Becomes Law
Reporter: Aviva Lev-Ari, PhD, RN
- The 21st Century Cures Act seeks to expedite development of, and provide priority review for, “breakthrough” devices
- The act requires FDA to provide training on the meaning and implementation of the least burdensome review standard, and requires an audit of the results
- The act expressly excludes certain categories of medical software from FDA regulation
Major provisions of the act related to medical device regulation found in Subtitle F are listed, below.
President Obama recently signed the 996-page 21st Century Cures Act to implement a variety of reforms to the Food and Drug Administration’s (FDA) regulation of the medical device and pharmaceutical industries.
This alert summarizes the major provisions of the act related to medical device regulation found in Subtitle F.
Section 3051 – Breakthrough Devices
Section 3052 – Humanitarian Device Exemption (HDE)
Section 3053 – Recognition of Standards
Section 3054 – Certain Class 1 and Class II Devices
Section 3055 – Classification Panels
Section 3056 – Institutional Review Board Flexibility
Section 3057 – CLIA Waiver Improvements
Section 3058 – Least Burdensome Device Review
Section 3059 – Cleaning Instructions and Validation Data Requirement
Section 3060 – Clarifying Medical Software Regulation
A copy of the act can be found here.
For more information, please contact the Barnes & Thornburg LLP attorney with whom you work or one of the following attorneys in the firm’s Food, Drug & Device Group: Lynn Tyler at (317) 231-7392 or email@example.com; Beth Davis at (404) 264-4025 or firstname.lastname@example.org; or Alicia Raines Barr at (317) 231-7398 or email@example.com.
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