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MD 2093. 0002 October 9 2013 Ms. Patricia Sandbomn Beres Warsaw Indiana 46582 Trade/Device Name Comprehensive Convertible Glenoid Regulation Number 21 CFR 888. Fda.gov/Medicalflevices/ResourcesforYou/lndustry/default.htm. Also please note the regulation entitled Misbranding by reference to premarket notification 21CFR Pant 807. Applications with the addition of screw fixation. Interlok finish humeral stems are intended for cemented use and the MacroBond coated humeral stems are intended for...
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01
Start by reviewing the guidance documents provided by the FDA for filling out the summary of 510k.
02
Ensure that you have all the necessary information related to the medical device for which you are filling out the summary.
03
Begin by providing a clear and concise description of the medical device, including its intended use and indications for use.
04
Include any relevant performance characteristics and specifications of the device.
05
Provide a summary of the scientific and technical information supporting the safety and effectiveness of the device.
06
Include any applicable test results, clinical data, and studies that demonstrate the device's safety and performance.
07
Describe any potential risks associated with the device and the mitigations in place to address them.
08
Highlight any substantial changes made to the device or its labeling since the previous submission, if applicable.
09
Ensure that the summary is well-organized and easy to understand.
10
Proofread the summary for any grammatical or spelling errors before finalizing and submitting it.
Who needs a summary of 510k?
01
Manufacturers of medical devices who are seeking FDA clearance to market their products in the United States.
02
Regulatory affairs professionals who are responsible for preparing and submitting the 510k summary on behalf of the manufacturer.
03
FDA reviewers who evaluate the safety and effectiveness of medical devices based on the information provided in the summary.
04
Healthcare professionals who rely on the summary of 510k to make informed decisions regarding the use of medical devices.
05
Patients and consumers who are interested in understanding the safety and performance of medical devices before using them.
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What is a summary of 510k?
A summary of 510k is a concise overview of the submission made to the FDA for clearance of a medical device.
Who is required to file a summary of 510k?
Manufacturers of medical devices seeking FDA clearance are required to file a summary of 510k.
How to fill out a summary of 510k?
A summary of 510k is filled out by providing information on the device, its intended use, composition, design, and any potential risks.
What is the purpose of a summary of 510k?
The purpose of a summary of 510k is to provide a brief overview of the submission to the FDA for clearance of a medical device.
What information must be reported on a summary of 510k?
Information such as device description, intended use, design, materials, and testing data must be reported on a summary of 510k.
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