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Here are some useful links about regulatory issues:
- FDA's Center for Devices and Radiological Health (CDRH)
- www.fda.gov/cdrh
- FDA CDRH Device Advice
- www.fda.gov/cdrh/devadvice/
- FDA CDRH Division of Small Manufacturers, International and Consumer
Assistance (DSMICA)
- www.fda.gov/cdrh/industry/support/
- FDA CDRH Recent Additions
- www.fda.gov/cdrh/newpg.html
- Code of Federal Regulations
-
www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm
- Federal Register
- www.gpoaccess.gov/fr/index.html
- Certificates, Licenses and Permits
- http://www.dshs.state.tx.us/license.shtm
- Drugs and Medical Devices Division
-
www.dshs.state.tx.us/dmd/default.shtm
- Medical Device Distributor and Manufacturer Rules & Regulations
-
http://www.dshs.state.tx.us/dmd/dmdrules.shtm#mddm
Industry Associations
- Advanced Medical Technology Association (AdvaMed)
- www.advamed.org
- American College of Clinical Engineering (ACCE)
- www.accenet.org
- American Society for Quality (ASQ)
- www.asq.org
- ASQ Biomedical Division (ASQ Biomed)
- www.asq.org/biomed/
- Contact Lens Manufacturers Association (CLMA)
- www.clma.net
- Food & Drug Law Institute (FDLI)
- www.fdli.org
- Medical Device Manufacturers Association (MDMA)
- www.medicaldevices.org
- Regulatory Affairs Professionals Society (RAPS)
- www.raps.org
International
- Health Canada
- www.hc-sc.gc.ca/english/
- Europa
- www.europa.eu.int/
- European Confederation of Medical Devices Associations
- www.eucomed.be/
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