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Wildwood Family Clinic
Distance: 12.3 Mi4901 Cottage Grove Rd
53716 Madison -
Homeopathy 2 Health
Distance: 14.1 Mi406 N Pinckney St
53703-1410 Madison -
Neuwave Medical
Distance: 15.2 Mi3591 Anderson St
53704 Madison -
Lions Eye Bank of Wisconsin
Distance: 15.8 Mi2302 International Ln Ste 200
53704-3157 Madison -
Dr. Dave Goodman Independent Medical Examinations
Distance: 14.5 Mi2222 Van Hise Ave
53726 Madison
Quality & Regulatory Associates
- 800 Levanger Ln
- Stoughton, Wisconsin
- 53589-4614
- Phone: 608.877.2635
- Website
Description
An updated device listing on Form FDA 2892, deleting any listing for the product no longer marketed by that company. To make the FDA aware of the new owner of the transferred 510(k), a medical device listing should be made to FDA, using From FDA 2892. After 510(k) transfer of ownership, medical device listing is a method for FDA to identify manufactures by device classification. This identification allows FDA to provide mailings and alerts to manufactures by device classifications.
General Controls include: Establishment Registration by manufacturers, distributors, repackages and re-labelers, Medical Device Listing with FDA of devices to be marketed, Manufacturing the devices in accordance with Good Manufacturing Practices, Labeling medical devices in accordance with the labeling regulations, 21 CFR 801 or 21 CFR 809, Medical Device Reporting of adverse events as identified by the user, manufacturer and/or distributor of the medial device.
Many medical device manufactures have demonstrated compliance to the Food and Drug Administration (FDA) Quality System Regulations, ISO 9001:1994 or ISO 9002:1994 and to support compliance with the European Medical Device Directive compliance with EN 46001 or EN 46002. The EN 46001 and EN 46002 standards use the ISO 9001:1994 and ISO 9002:1994 standards as a baseline, adding specific requirements for medical devices. A fundamental concern is what will happen with the EN 46001 and EN 46002 standards with the release and transition to the ISO 9001:2000 standard.
The Food and Drug Administration does not intend on changing the Quality System Regulation (QSR) in Title 21 Code of Federal Regulations Part 820. Medical device manufacturers with international sales will need to develop and maintain quality system compliance to both the FDA QSR and ISO 13485:1996 quality system standards. Within the three year transition period, ISO 13485:2003 quality system standard compliance will be required.