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Additional Information About Post-Approval Studies Conducted with Medical Devices Now Available
FDA is taking steps to improve transparency about studies conducted with devices after approval. The Center for Devices and Radiological Health (CDRH) has a program that oversees studies that are required as a condition of approving certain applications. The CDRH Post-Approval Studies (PAS) program helps to ensure that well-designed post approval studies are conducted effectively and efficiently and in the least burdensome manner.
CDRH launched a webpage so that the public can keep informed of the progress of each post-approval study. The webpage displays general information about each post-approval study and now more information is available, including information about the study design, population studied, and data collection methods. For completed studies, you can find information about final study results, safety and effectiveness findings, strengths and weaknesses of the study, and recommended labeling changes, if any.
This post will be last one until January 2011. Happy holidays to all of our readers and best wishes for the New Year!
Afia Asamoah, Transparency Initiative Coordinator
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FDA’s Center for Devices and Radiological Health (CDRH) Launches Inspections Database
Yesterday, as part of the FDA Transparency Initiative, CDRH launched the ‘CDRH Inspections Database’. The database provides information about medical device inspections that were the responsibility of CDRH from 2008 to the present (approximately 25% of the medical device inspections conducted since 2008). The database contains information about the firms, types of devices and inspections, and links to warning letters (when available).
You can search the inspection database by various parameters, including company name, inspection type, product code, inspection classifaction, inspection action, and date. You can find the database here.
We encourage your feedback on the database and welcome your suggestions for additional information you would like to see. You can provide feedback on the FDA Web site.
Afia Asamoah, Transparency Initiative Coordinator
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Upcoming Event: FDA Public Webinar About the “510(k) Premarket Review Process” and the “Use of Science in Regulatory Decision Making” Draft Reports, Tuesday, August 31, 1:00 p.m. ET
FDA recently published two preliminary reports conducted by the Center for Devices and Radiological Health (CDRH). The first preliminary report is an assessment of the process used to review certain medical device applications before they are marketed (known as the 510(k) process) and draft recommendations. The second preliminary report is an assessment of the use of science in CDRH's regulatory decision making and draft recommendations. This is the first step in determining what, if any, improvements to these processes FDA may implement.
Next week, FDA is hosting a webinar where CDRH officials will discuss the details of both reports. There will be an opportunity to ask questions.
The live webinar will be held on Tuesday, August 31, at 1:00 p.m. ET.
There are a limited number of spots available for the webinar. Click here for more information about the webinar, which includes a link to join the webinar on August 31.
FDA is also soliciting comments from the public on the draft reports via www.regulations.gov, docket number FDA-2010-N-0348.
Afia Asamoah, Transparency Initiative Coordinator
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Materials Available from FDA Basics Webinar on “Indoor Tanning: Risks of UV Radiation”
Did you miss the FDA Basics webinar on “FDA’s Regulation of Tobacco Products”?
Check out the “What’s New” box on the FDA Basics home page to download materials from the webinar. We have posted a link to listen to the entire 30 minute webinar as well posted a link to download a copy of the presentation slides.
You can find materials from past FDA Basics webinars here.
Afia Asamoah
Transparency Initiative Coordinator
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Upcoming Events: FDA Basics Webinar on Indoor Tanning: Risks of UV Radiation, Wednesday, May 26, 2 p.m. ET
Do you have questions about Indoor Tanning? Did you know that FDA regulates tanning beds?
As part of FDA Basics, FDA is hosting a webinar where you can learn more. Featured speakers, Sharon Miller, M.S.E.E., FDA Ultraviolet Radiation Expert and Varsha Savalia, M.P.H, FDA Tanning Products Compliance Officer from the Division of Mammography Quality and Radiation Programs, Center for Devices and Radiological Health, will explain what UV radiation is, discuss the risks of UV radiation, and describe steps to reduce the risks associated with the use of tanning beds. After the presentation, there will be an opportunity to ask questions.
The free 30 minute webinar will be held on Wednesday, May 26, at 2 p.m. ET.
There are a limited number of spots available for the webinar. Materials from the webinar will also be made available on the FDA Web site. Click here for more information, including instructions about how to join the webinar.
Afia Asamoah
Transparency Initiative Coordinator
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FDA Launches Medical Device and Radiation-Emitting Product Transparency Web Site
Today, the U.S. Food and Drug Administration (FDA) launched the Center for Devices and Radiological Health (CDRH) Transparency Web site in support of the agency’s Transparency Initiative. This site will provide information about medical device and radiation-emitting product regulatory processes and decisions, and summaries of data to support those decisions.
The new Web site is part of an ongoing effort within FDA to enhance communication and transparency. This Web site makes available new information about CDRH’s decision-making processes and displays this information in a more user-friendly format. The site includes new information such as:
- basic information about medical devices and how FDA regulates those products
- information about medical devices before and after the products are on the market, in a searchable database
- information about the clinical studies and trials conducted to demonstrate the safety and effectiveness of certain medical devices
- memos from FDA employees explaining the reasons for the agency’s decisions about medical device manufacturer requests to make a significant change in components, materials, design, specification, software, color additive, and labeling of a medical device
- a step-by-step guide for manufacturers of radiation-emitting products to assist with the regulatory process
CDRH plans to add new information about premarket submissions, product performance & safety, compliance & enforcement, and science & research to this website monthly.
The Web site includes a feedback feature that will allow CDRH to collect input and suggestions from the public about the information provided. Visit the CDRH Transparency Web site at www.fda.gov/CDRHTransparency and let us know what you think. Feedback provided will be used to improve and expand the website.
Afia Asamoah
Transparency Initiative Coordinator
