Related Experiment Video
Updated: Dec 25, 2025
07:06
Primary Clarification of CHO Harvested Cell Culture Fluid using an Acoustic Separator
Published on: May 14, 2020
5.5K
Dermatologic Device Clearance Within the Food and Drug Administration's 510(k) Pathway.
Harib H Ezaldein1, Sheena T Hill1, Miesha Merati1
1Department of Dermatology, University Hospitals Cleveland Medical Center, Case Western Reserve University, 11100 Euclid Avenue, Cleveland, Ohio, 44106.
Lasers in Surgery and Medicine
|March 30, 2020
Summary
Dermatologic device clearance via the 510(k) pathway is increasing, with most devices cleared based on substantial equivalence and minimal clinical data. Laser/thermal devices, wound care, and light-based devices dominate this regulatory pathway.
Area of Science:
- Dermatology
- Medical Device Regulation
- Regulatory Science
Background:
- Device innovation in dermatology is rapidly advancing.
- The United States Food and Drug Administration (FDA) 510(k) pathway allows devices to be cleared if they are substantially equivalent to predicate devices.
- This pathway has faced criticism for potentially less stringent clinical data requirements.
Purpose of the Study:
- To characterize the clearance of dermatologic devices through the FDA's 510(k) pathway.
- To analyze trends and decision characteristics of dermatologic device clearances.
- To understand the implications of the 510(k) pathway for dermatologic innovation.
Main Methods:
- A retrospective review of the FDA's 510(k) database was conducted.
- Data spanned from January 1, 1996, to December 31, 2018.
- Dermatologic devices were identified by product code and classified by application.
Main Results:
- Out of 76,607 records, 4,637 dermatologic devices met inclusion criteria.
- Laser/thermal devices (64.2%) were the largest category, followed by wound (24.0%) and light-based (5.8%) devices.
- Most devices (98.5%) were cleared as substantially equivalent without limitations, and clearance rates increased overall, except for laser/thermal devices.
Conclusions:
- Dermatologic devices are increasingly cleared via the 510(k) pathway.
- Clearance is often based on substantial equivalence with minimal premarket clinical data.
- This trend highlights the regulatory landscape for new dermatologic technologies.
