Section 513(g). A written inquiry to CDRH can result in a determination of the classification (Class I, II or III). See http://www.fda.gov/MedicalDevices/ResourcesforYou/
Industry/ucm127147.htm
Compliance Consultants can research your proprietary design
and formulate a description to submit to the CDRH to enable
the appropriate response with an authentic regulatory
classification via a Section 513(g) request. We do this on a
fixed fee. The CDRH also requires a user fee.
We can initialize an accurate description as part of a "technical investigation". We will explore (on a confidential basis) the proprietary performance and regulatory issues of your Product Classification and Product Code. We do all this without revealing or involving your company's interest or identity.
What do you have... Software, device, material, endoscope, Laser, electronic device?
Is your device classified or under the authority of the FDA?
What is the classification and product code?
What claims can you make with the appropriate application?
What applications can you OR must you file?
What labeling can or must be presented?
What regulatory claims serve your marketing & safety purposes?
We can initialize an accurate description as part of a "technical investigation". We will explore (on a confidential basis) the proprietary performance and regulatory issues of your Product Classification and Product Code. We do all this without revealing or involving your company's interest or identity.
What do you have... Software, device, material, endoscope, Laser, electronic device?
Is your device classified or under the authority of the FDA?
What is the classification and product code?
What claims can you make with the appropriate application?
What applications can you OR must you file?
What labeling can or must be presented?
What regulatory claims serve your marketing & safety purposes?
