C
celia4237
Re: Questions about the classification of medical device in FDA
The following is the response i get from FDA, i think it is a good teaching-material about classification of medical device and i'd like to share with you.
---------------------------------------------------------------------
To determine the classification of your product, you can search our classification database, premarket notification 510(k) database for predicate product or competitors product or submit a 513(g) request for classification.
The classification database is located at the following web address: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPCD/classification.cfm
In the "Device" field of the classification database enter "device name," for example, "loupe" then hit search and all possible classifications will appear for these products. I also suggest searching in the "Review Panel" field. Click on the arrow, stroll down to "Ophthalmic" then hit search. The classification database will determine if your product requires marketing clearance via Premarket Notification 510(k) submission, 510(k) exempt or Premarket Approval (PMA) process. If your products is 510(k) exempt, you would need to register your establishment and list your medical device electronically in order to market in the U.S.
You can also access the classification database from the following website: All CDRH Databases (broken link removed) (Go down to product classification, in the Search for field enter "device name, for ex., "loupe").
A list of cleared 510(k) marketing application is available on the Web. You can conduct searches for predicate devices at the following 510(k) database web address: (broken link removed). If you know of another company who makes a product similar to yours, you can search this database for a possible classification. You can search by product code, product name, company name, 510(k) number, etc. and all cleared 510(k)s for that product will appear. Once you conduct your search, you can select, if available, the highlighted "statement or summary" of the product. It will show the "indication for use" for the product.
Questions concerning the classification of a device or the regulatory requirements applicable to a device can be submitted, via the mail only, to the FDA . The request is authorized under Section 513(g) of the Federal Food, Drug, and Cosmetic Act (Act). The Act was amended by the Medical Device User Fee and Modernization Act of 2002 (MDUFMA) and the FDA Amendments Act of 2007 (FDAAA) (Public Law 110-85), which authorize FDA to collect user fees for 513(g) submissions. Information on user fees and how to submit your user fee payment may be found at (broken link removed). The Small Business Qualification Worksheet and Certification, which explains how you may qualify for a fee discount for 513(g) submissions you make during FY 2008, can be found at the same web site.
The 513(g) request should include:
A copy of the MDUFMA Fee Sheet.
A cover letter stating the submission is a 513(g) request for information concerning the device status, classification and regulatory requirements applicable to your device. The cover letter should contain the contact person's name, address, telephone number and fax number.
A detailed description of your product/device.
A concise Indication(s) for Use Statement.
Either proposed labeling for your product/device or labeling of a marketed similar device. If no labeling is available, you should so note in your cover letter.
If you decide to send a request, please submit the 513(g) request to the following address:
513(g) Coordinator
c/o Document Mail Center (HFZ-401)
Office of Device Evaluation
Center for Devices and Radiological Health
9200 Corporate Boulevard
Rockville, MD 20850
The following is the response i get from FDA, i think it is a good teaching-material about classification of medical device and i'd like to share with you.
---------------------------------------------------------------------
To determine the classification of your product, you can search our classification database, premarket notification 510(k) database for predicate product or competitors product or submit a 513(g) request for classification.
The classification database is located at the following web address: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPCD/classification.cfm
In the "Device" field of the classification database enter "device name," for example, "loupe" then hit search and all possible classifications will appear for these products. I also suggest searching in the "Review Panel" field. Click on the arrow, stroll down to "Ophthalmic" then hit search. The classification database will determine if your product requires marketing clearance via Premarket Notification 510(k) submission, 510(k) exempt or Premarket Approval (PMA) process. If your products is 510(k) exempt, you would need to register your establishment and list your medical device electronically in order to market in the U.S.
You can also access the classification database from the following website: All CDRH Databases (broken link removed) (Go down to product classification, in the Search for field enter "device name, for ex., "loupe").
A list of cleared 510(k) marketing application is available on the Web. You can conduct searches for predicate devices at the following 510(k) database web address: (broken link removed). If you know of another company who makes a product similar to yours, you can search this database for a possible classification. You can search by product code, product name, company name, 510(k) number, etc. and all cleared 510(k)s for that product will appear. Once you conduct your search, you can select, if available, the highlighted "statement or summary" of the product. It will show the "indication for use" for the product.
Questions concerning the classification of a device or the regulatory requirements applicable to a device can be submitted, via the mail only, to the FDA . The request is authorized under Section 513(g) of the Federal Food, Drug, and Cosmetic Act (Act). The Act was amended by the Medical Device User Fee and Modernization Act of 2002 (MDUFMA) and the FDA Amendments Act of 2007 (FDAAA) (Public Law 110-85), which authorize FDA to collect user fees for 513(g) submissions. Information on user fees and how to submit your user fee payment may be found at (broken link removed). The Small Business Qualification Worksheet and Certification, which explains how you may qualify for a fee discount for 513(g) submissions you make during FY 2008, can be found at the same web site.
The 513(g) request should include:
A copy of the MDUFMA Fee Sheet.
A cover letter stating the submission is a 513(g) request for information concerning the device status, classification and regulatory requirements applicable to your device. The cover letter should contain the contact person's name, address, telephone number and fax number.
A detailed description of your product/device.
A concise Indication(s) for Use Statement.
Either proposed labeling for your product/device or labeling of a marketed similar device. If no labeling is available, you should so note in your cover letter.
If you decide to send a request, please submit the 513(g) request to the following address:
513(g) Coordinator
c/o Document Mail Center (HFZ-401)
Office of Device Evaluation
Center for Devices and Radiological Health
9200 Corporate Boulevard
Rockville, MD 20850
