FDA Information
Janus Development Group receives numerous inquiries regarding our SpeechEasy® device with regards to whether or not the device is "FDA Approved". The following information should serve to clarify the device classification, registration, and exemption from this ‘FDA approval’ process. The majority of the text below comes from the FDA website, www.fda.gov.
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Classification
Medical devices are assigned by the FDA to Class I, low risk devices, Class II, moderate risk devices, or Class III, high risk devices based on intended use, indications for use, and risk. Device classification depends on the intended use of the device and also upon indications for use. Indications for use can be found in the device's labeling, but may also be conveyed orally during sale of the product. Class I includes devices with the lowest risk and Class III includes those with the greatest risk. SpeechEasy® has been assigned by the FDA to device Class I.
Class I devices are subject to the least regulatory control. They present minimal potential for harm to the user and are often simpler in design than Class II or Class III devices. Class I devices are subject to "General Controls" or baseline requirements of the Food, Drug and Cosmetic (FD&C) Act that apply to all medical devices, Class I, II, and III.
General controls include:
- Establishment Registration of companies which are required to register under 21 CFR Part 807.20, such as manufacturers, distributors, repackages and relabelers. Foreign establishments, however, are not required to register their establishments with FDA.
- Medical Device Listing with FDA of devices to be marketed.
- Manufacturing devices in accordance with Good Manufacturing Practices (GMP) in 21 CFR Part 820.
- Labeling devices in accordance with labeling regulations in 21 CFR Part 801 or 809.
- Submission of a premarket notification [510(k)] before marketing a device. (Most Class I devices are exempt from the premarket notification and/or good manufacturing practices regulation.)
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Compliance Documentation
The SpeechEasy® device has been designated "an air conduction anti-stammering device" and assigned to device Class I. It is among those devices exempted from premarket notification [510(k)] and is not subject to premarket approval (PMA). Furthermore, Janus Development Group, Inc. (as manufacturer of the SpeechEasy® device) is in full compliance with FDA general controls and requirements for marketing SpeechEasy® as a Class I medical device as evidenced by the following:
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The Product Classification listing for the SpeechEasy® device:
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPCD/classification.cfm?ID=3494
Product Classification Database
Device device, anti-stammering Device Description Antistammering device. Medical Specialty Ear Nose & Throat Product Code KTH Regulation Number 874.5840 Device Class 1 GMP Exempt? No 510(k) Exempt? Yes Note: FDA has exempted almost all class I devices (with the exception of Reserved Devices) from the premarket notification requirement, including those devices that were exempted by final regulation published in the Federal Registers of December 7, 1994, and January 16, 1996. It is important to confirm the exempt status and any limitations that apply with 21 CFR Parts 862-892. Limitations of device exemptions are covered under 21 CFR xxx.9, where xxx refers to Parts 862-892.
If a manufacturer's device falls into a generic category of exempted class I devices as defined in 21 CFR Parts 862-892, a premarket notification application and FDA clearance is not required before marketing the device in the U.S. However, these manufacturers are required to register their establishment by submitting Form FDA 2891, "Initial Registration of Device Establishment," and list the generic category or classification name of the device by submitting Form FDA 2892, "Device Listing."
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The Device Listing Database entry for the SpeechEasy® device on the FDA website. This database contains a listing of medical devices in commercial distribution by both domestic and foreign manufacturers. http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRL/Listing.cfm?ID=78899
Device Listing Database Proprietary Device Name: DEVICE, ANTI-STAMMERING Common/Generic Device Name: ANTI-STUTTERING DEVICE Classification Name: DEVICE, ANTI-STAMMERING Device Class: 1 Product Code: KTH Regulation Number: 874.5840 Medical Specialty: Ear Nose & Throat Owner/Operator: JANUS DEVELOPMENT GROUP, INC. Owner/Operator Number: 9046227 Registered Establishment Name: JANUS DEVELOPMENT GROUP, INC. Establishment Registration Number: 1066749 Date of Listing: 05/15/01 Listing Status: Active Establishment Operations: Manufacturer -
The applicable Code of Federal Regulations for the SpeechEasy® device (21CFR874.5840): http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCFR/CFRSearch.cfm?FR=874.5840
"[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR874.5840]TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
PART 874--EAR, NOSE, AND THROAT DEVICES
Subpart F--Therapeutic DevicesSec. 874.5840 Antistammering device.
(a) Identification. An antistammering device is a device that electronically generates a noise when activated or when it senses the user`s speech and that is intended to prevent the user from hearing the sounds of his or her own voice. The device is used to minimize a user`s involuntary hesitative or repetitive speech.
(b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to Sec. 874.9.[51 FR 40389, Nov. 6,1986, as amended at 65 FR 2316, Jan. 14, 2000]"
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The Establishment Registration Database entry for Janus Development Group, Inc. on the FDA website. This is a searchable database of domestic establishments engaged in the manufacture, preparation, propagation, compounding, assembly, or processing of medical devices intended for human use and commercial distribution. http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRL/registration.cfm?ID=19574
Establishment Registration Database
Establishment:
JANUS DEVELOPMENT GROUP, INC.
112 staton rd.
greenville, NC 27834
Registration Number: 1066749
Operations: Initial Distributor, Manufacturer
Status: Active
Date of Registration Status: 2004Owner/Operator:
JANUS DEVELOPMENT GROUP, INC.
1800 N. GREENE ST.
GREENVILLE, NC 27834
Owner/Operator Number:
9046227Official Correspondent:
MR. ALAN NEWTON
JANUS DEVELOPMENT GROUP, INC.
112 STATON ROAD
GREENVILLE, NC 27834
Phone: 252-551-9042
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Should you need any further clarification regarding the SpeechEasy® device or its FDA status, please contact Janus Development Group, Inc. (www.janusdevelopment.com) or visit the FDA website (www.fda.gov).
