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# Team Finds Loopholes in FDA Dermatologic Device Review
- URL: https://www.fdaweb.com/team-finds-loopholes-in-fda-dermatologic-device-review/
- Published: 2018-02-01T12:00:00.000Z
- Updated: 2026-09-14T23:19:09.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5140655

Yale University says that a team of its researchers found that FDA’s multi-stage review and alternation process for dermatologic devices has potentially dangerous loopholes. The team [reports](https://yaledailynews.com/blog/2018/02/01/study-identifies-fda-review-process-loopholes/?ref=fdaweb.com) that many dermatologic devices had been altered after going through the review process, with limited agency inspection. After alteration, it says, the products were not reviewed as thoroughly as they had been during their initial screenings. As a result, some devices were re-released with dangerous modifications, the study concludes.

Team members say they do not believe that current consumers are in any substantial danger due to alterations to products. They say they did not find any instances of a change in a dermatologic device creating a Class 1 recall.

The report notes that over the last 20 years, most assessments of dermatologic devices were through the 30-day track, while the strictest panel review track was used the least. “The popularity of the 30-day process increases the chance of mistakes in the review and can pose a threat to consumer safety,” the study says.

While in theory the selected track should correspond to the type of changes under review, the research team found that a particular track does not always correlate to its designated modification. For example, the report says, small post-market design changes should match up with the real-time review track. But the team found that FDA used that track for the corresponding change less than half the time. “A more relaxed review process also may open the door to dangerous numbers of modifications,” the researchers say. “Some of the devices reviewed had undergone as many as 84 modifications.”