The term does not include a person who repackages a finished device or who otherwise changes the container, wrapper, or labeling of the finished device or the finished device package.
You may be eligible for a Multiple Products License if your firm distributes two or more of the following products: food, nonprescription drugs, compressed medical gases, and medical devices.
A separate license is required if you are distributing prescription drugs other than compressed medical gases. Skip to content 3. Contact this Program. Search this Program Customer Surveys Please let us know how we are doing by completing our customer service survey. Federal Contract Comments.
Skip to content 3. Contact this Program. Search this Program Customer Surveys Please let us know how we are doing by completing our customer service survey.
Federal Contract Comments. Background Magellan Diagnostics, Inc. Recommendations Discontinue use of all affected test kit lotsexternal icon identified as part of the recall. Retesting should be done with a venous blood sample analyzed with higher complexity testing.
Retest children who were previously tested with a LeadCare test kit if the lot number of the initial test kit is unknown and the test was done after October 27, and July 6, , the date of this health advisory.
Priority for retesting should be given to— Children where there is clinical concern that symptoms or developmental problems may be related to lead exposure, Populations at higher risk of elevated blood lead levels, such as children tested due to Medicaid-required screening or due to other state or local requirements, and Individuals who are pregnant or breastfeeding. Licensing To become licensed as a medical device manufacturer or distributor, please visit the licensing requirements page , which outline options for online licensing and renewal as well as fee schedules and links to application forms.
Do I need two licenses? However, the licensing fee is based on the gross annual sales of both the manufactured and distributed items. A company that manufactures or distributes at more than one physical location must license each location according to the activities conducted at the particular location. In addition to distributing medical devices, I also intend to distribute food, nonprescription drugs, and compressed medical gases. What type of license do I need? To be eligible for a Multiple Products License, you must be distributing at least two of the following products: medical devices, food, nonprescription drugs, and compressed medical gases.
A separate license is needed if you are doing any manufacturing or distribution of prescription drugs other than compressed medical gases. To learn more, visit the Multiple Products website. Can my private residence be licensed as a device manufacturer or distributor? No manufacturing, assembling, packaging, packing, holding, testing, or labeling operations of devices by device manufacturers or distributors shall be conducted at any personal residence. Your license application form requests information concerning the types of devices I manufacture or distribute.
The U. Food and Drug Administration FDA is responsible for classifying all devices based upon the level of control necessary to assure the safety and effectiveness of the device. Class I devices are subject to the least regulatory control and usually present minimal potential for harm to the user.
Examples of Class I devices include elastic bandages, examination gloves, non-absorbable gauze, manual wheelchairs, crutches, walkers, nonprescription sunglasses, incontinence garments, eye pads and enema kits. Class II devices are those for which general controls alone are insufficient to assure safety and effectiveness and are therefore also subject to special controls. Examples of Class II devices include powered wheelchairs, infusion pumps, sterile surgical drapes, blood glucose meters, nebulizers, X-ray systems, TENS units, oxygen concentrators, lasers and diagnostic ultrasound devices.
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