Free white paper improves chances of FDA 510(k) clearance on the first pass
Boxborough, MA, August 16, 2010 — Intertek, a global leader in testing, inspection and certification, is offering a free white paper, Guide to Building a Successful 510(k) Submission, educating medical device manufacturers on how to avoid the most common pitfalls that cause delays in the 510k submission process.
Selling medical devices in the US requires product approval through the US Food and Drug Administration (FDA). Submissions to the FDA that are poorly organized, do not follow current practices, contain inconsistencies between documents, or lack information will result in significant delays in the clearance process.
Writing and assembling a complete and well structured 510(k) submission, as well as following the suggestions and guidance that FDA provides to the Medical Device Community, drastically improves the likelihood of FDA clearance on the first pass. This will save you time and money, and can make your product more competitive in the market.
This free white paper focuses on the structure and key elements of the 510(k) submission and explains in clear language the most common pitfalls to avoid in the development of your 510(k) submission to the FDA.
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Download the white paper, to Building a Successful 510(k) Submission at http://ilnk.me/510kwp
For more information on Intertek’s photovoltaic testing services, visit www.intertek.com/510k
