mdi ConsultantsNEWS FLASH!!!
The FDA has rethought their decision on re-classifying Clinical Electronic Thermometers to 510(k) exempt. mdi was part of the this process for the FDA to re-evaluate this decision. The FDA’s decision of making such an important clinical monitoring device to be marketed without FDA 510(k) clearance was “just not a good idea” and didn’t make any sense.
So, now Clinical Electronic Thermometer Makers are being made aware that on July 6, 2015, FDA updated their product code database regulatory status for product code FLL, Clinical Electronic Thermometer. As of Monday, July 6, 2015, FDA is requiring 510(k) submissions for product code FLL (no longer 510(k) Exempt per FDA’s September 2014 list of Class II devices that became 510(k) Exempt). The Class II Medical Device Exemption List has also been updated that now reflects the deletion of product code FLL: PART 880 GENERAL HOSPITAL AND PERSONAL USE DEVICES
FDA’s Stand:
CDRH reviewed the device types (product codes) included in the draft guidance document “Intent to Exempt Certain Unclassified, Class II, and Class I Reserved Medical Devices from Premarket Notification Requirements.” and determined that two device types (product codes) originally proposed in the draft guidance document should not be included in the final guidance as devices for which FDA intends to exempt from premarket notification requirements:
- FLL—Thermometer, Electrical, Clinical (21 CFR 880.2910); and
- GWO—Plate, Cranioplasty, Preformed, Alterable (21 CFR 882.5320).
CDRH determined that premarket notification (510(k)) is necessary to assure the safety and effectiveness of these devices. Notably, the FLL product code currently covers thermometers with a range of technologies and intended uses, including those used to screen for potential pandemic contagious diseases. CDRH believes that some thermometer types may be candidates for exemption from premarket notification requirements at a later date, but that thermometers should first be further categorized by technology and/or intended use into distinct product codes. CDRH is actively reviewing this issue and will further consider which of the sub-types may be appropriate to exempt from premarket notification requirements.
For currently marketed FLL product code thermometers:
PLEASE NOTE: THIS IS VERY IMPORTANT INFORMATION FOR COMPANIES WHO DECIDED TO DISTRIBUTE THESE THERMOMETERS WITHOUT A 510(K)
CDRH recognizes that manufacturers of thermometers which are out there in the US market without a 510(k) clearance may not have submitted a 510(k) for the FLL device type following publication of the draft guidance. As a result, CDRH is providing such manufacturers 90 days following the publication of this notice (July 1st 2015) to submit a 510(k) for these device types; however, distribution and marketing of such devices must cease if a manufacturer receives an order from FDA declaring the device to be not substantially equivalent to any legally marketed predicate device.
If you have any FLL product code thermometers currently marketed without a 510(k), please let us know and mdi will help to outline an appropriate regulatory strategy to market these thermometers which now require a 510(k) clearance. mdi has an extensive experience in 510(k) submissions and has around 1900 510(k) successful FDA 510(k) clearances.
? Email us at info@mdiconsultants.com if you have any questions about the FLL product code clinical thermometers and REF: Product Code FLL – 510(k)