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# ‘Cures Act’ Medical Device Implications Explained
- URL: https://www.fdaweb.com/cures-act-medical-device-implications-explained/
- Published: 2016-12-12T12:00:00.000Z
- Updated: 2026-09-14T21:53:49.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5137546

Attorneys **Nathan Brown**, **Marlee Gallant**, and **Eli Tomar** (Akin Gump) say that new authorities in the 21st Century Cures Act give FDA greater flexibility in regulating medical devices, but their ultimate impact will depend on how they are implemented by the agency under a new administration. Writing in an online [post](https://www.akingump.com/en/news-insights/key-implications-of-the-21st-century-cures-act-for-medical.html?ref=fdaweb.com), the attorneys say that because the Cures provisions are more heavily focused on premarket review, there is likely to be additional consideration of postmarket device surveillance in next year’s FDA reauthorization process.

The post discusses these changes affecting medical devices: 

- creation of a priority review program for “breakthrough” devices modeled on the breakthrough pathway for drugs;
- clarification of which types of digital health software applications constitute medical devices;
- software provisions in the bill address medical device accessories;
- requirement that FDA publish a list of reusable device types for which 510(k) clearance will require validated instructions for use and validation data on cleaning, disinfection, and sterilization;
- expansion of the humanitarian device exemption to devices that treat or diagnose a disease or condition affecting no more than 8,000 individuals in the U.S. per year;
- requirement that FDA provide training to medical device reviewers on the meaning and implementation of the “least burdensome” principles of the Federal Food, Drug, and Cosmetic Act;
- centralized institutional review boards for multi-center trials;
- establishment of a process for submission, review, and recognition of standards established by nationally or internationally recognized standard organizations to facilitate medical device review;
- requirement that FDA to publish lists of certain Class 1 and Class 2 devices newly exempted from 510(k);
- improvement of medical device classification panels by ensuring adequate expertise among panel members, allowing a sponsor to offer recommendations on the required expertise, and permitting a sponsor representative to address the panel; and
- · requirement that FDA update its 2008 guidance on determining when a test is eligible for a Clinical Laboratory Improvement Amendments of 1988 waiver by allowing for demonstration of accuracy through comparable performance between a waived and a moderately-complex user.

 The post also discusses other FDA-related provisions that are not solely directed at medical devices, but hold implications for device makers.