CDRH Transparency Website Feedback Summary
On Monday, April 19, 2010, the Center for Devices and Radiological Health (CDRH) launched the CDRH Transparency Website as part of FDA's transparency initiative.
What We Asked
Visitors to the Website were asked to provide feedback in the following 3 general areas:
- What information did you look at in this section?
- Did you find this information useful?
- What information would you like to see CDRH post in the future?
Additionally, visitors to the Total Product Life Cycle (TPLC) page were asked to provide feedback on the following questions:
- Did you find this information useful?
- Is providing information by the product code useful?
- Is it helpful to see the Adverse Event/MDR data?
- Is more information needed to understand event frequency?
- What else would you like on a TPLC Report?
CDRH would like to thank all respondents for their feedback and suggestions. In general, the Website has been very well received. We received 46 comments since the launch of the Website on April 19, 2010 until May 28, 2010. The majority of respondents (34) found the Website very useful. The remainder (12) found it somewhat useful.
Areas Commented On
Listed below is a breakdown of the areas where comments were received:
- CDRH Transparency Homepage – 17 comments
- Total Product Life Cycle – 17 comments
- PMA Clinical Trials – 5 comments
- Premarket – 3 comments
- Postmarket – 2 comments
- Science & Research – 1 comment
- Performance Data – 1 comment
Suggestions for Improvement
Of the 46 comments received, there were 17 suggestions for improvement: some of which were mentioned more than once. Here is an overview of suggestions we received and CDRH response to those suggestions.
- Links to other Useful Databases: We have added links to Medical Device Databases and the CDRH Management Directory in the "Resources for You" box on the left side of the CDRH Transparency Homepage.
- RSS Feeds for Databases We are looking into the feasibility of this with FDA's Office of Information Management.
- More Clinical Trial Data: Our plan is to include all PMA clinical trial data.
- More PMA Supplement Summaries: After the pilot, we will assess the feasibility of expanding to other types of PMA supplements.
- PMA Summary Form Like The IDE Form: We are looking at what other internal forms we can publicly release.
- Link PMA Clinical Trial Data to Postmarket Information: In the future, PMA Clinical trial data will be included in the Total Product Life Cycle (TPLC) reports.
- Associate MDRs with TPLC reports: We are validating the MAUDE data and will provide this information in the future.
- Search the TPLC database by brand names or company names: We are assessing the feasibility of adding this feature.
We encourage your feedback on this information and would welcome your suggestions for additional information you would like to see.