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# Comments on Coronary Drug-Eluting Stent Guidance
- URL: https://www.fdaweb.com/comments-on-coronary-drug-eluting-stent-guidance/
- Published: 2019-01-31T12:00:00.000Z
- Updated: 2026-09-15T00:59:18.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5143274

AdvaMed praises FDA for reopening the comment period on two coronary drug-eluting stent guidances that are 10 years old. In its comment [letter](https://www.regulations.gov/document?D=FDA-2008-D-0180-0016&ref=fdaweb.com), the association says that FDA and industry have learned a lot in the last 10 years about the design, development, and production of high quality products and about their performance in patients.

“Because of the knowledge and experience gained during the past 10 years,” AdvaMed says, “it is an appropriate time to consider the original testing requirements to determine if they continue to be necessary.”

Specific comments on the guidances were submitted by AdvaMed as well as [Cook Group](https://www.regulations.gov/document?D=FDA-2008-D-0180-0017&ref=fdaweb.com), [Biotronik](https://www.regulations.gov/document?D=FDA-2008-D-0180-0019&ref=fdaweb.com), and [CardioMed Device Consultants](https://www.regulations.gov/document?D=FDA-2008-D-0180-0018&ref=fdaweb.com).