Dear Rebeca Chan, Based on the information that you provided, a device such as your electrode device could be classified as a Class I device. A submittal to FDA under a 510k plan may or may not be necessary. It is hard to say with the limited information provided. The key question here is how does it attach to the skin to record electrical signals. A product type search may be necessary to determine if it is similar to a device that is on the market in the United States. The thing to note for design here, is to ensure that your device is substantially equivalent in functionality to the device on the market (or precursory device). A function to function comparison must be made to determine equivalency. Your device will be subject to the same requirements as the precursory device. So you will also need to take special note as to what the special requirements of the precursory device are. You may find these to be more limited to what you will like to be applied to your device.
The drawback to this is if a thorough comparison of your device to the precursory is not made and you fail to recognize some critical deviations in your device functionality, the FDA may by default conclude that your device is not substantially equivalent to the precursory device. Your device could be upgraded to where it requires PMA (PreMaket Approval) . If possible, you want to avoid the PMA (Class III) or 510k (Class II) route. It is important to understand how the FDA reaches its decisions regarding substantial equivalence. Manufacturers of devices classified as Class II or Class III (and some Class I), are required to register their facilities and conform to the GMP (Good manufacturing Practices) regulations. ISO 9000 will go a long way as a good start towards satisfying this requirement. Please note that some devices classified as Class I are exempted from this requirement. Your device may fall in the exempted group. I hope this helps in answering your questions. Best Regards, Bandele Adepoju Rockford Engineering Services, Inc. Tel: 001-301-855-1375 Fax: 001-410-586-1460 Email: [email protected] Web; www.resemc.com ---------- From: [email protected] [SMTP:[email protected]] Sent: Thursday, August 13, 1998 4:32 PM To: [email protected] Subject: FDA requirements I am working on a machine that has electrodes that are attached to the skin to measure various electrical signals. This machine is battery powered. My question is : am I required to conform to any FDA design rules in this area ? When the machine goes into production, do I have to find a manufacturer that is specifically qualified to produce medical device ? Is a ISO9000 certification sufficient qualification for a manufacturer to produce this item ? Rebeca Chan --------- This message is coming from the emc-pstc discussion list. To cancel your subscription, send mail to [email protected] with the single line: "unsubscribe emc-pstc" (without the quotes). For help, send mail to [email protected], [email protected], or [email protected] (the list administrators).
