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Products and Medical Procedures fda.gov
Recently approved medical device -laboratory test used to detect...
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ADVIA® Centaur Anti-HBs2 (aHBs2) Assay and ADVIA® Centaur Anti-HBs2... accessdata.fda.gov
Labeling, Approval Order, and Summary of Safety and Effectiveness for...
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THE MEDICAL DEVICE TAX MEETING!
Are you ready for the medical device tax to be applied on January 1,...
Medical Device Tax Workshop -
Elecsys® Anti-HBc IgM Immunoassay and Elecsys® PreciControl Anti-HBc... accessdata.fda.gov
Labeling, Approval Order, and Summary of Safety and Effectiveness for...
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ADVIA® Centaur Anti-HBs2 (aHBs2) Assay and ADVIA® Centaur Anti-HBs2... accessdata.fda.gov
Labeling, Approval Order, and Summary of Safety and Effectiveness for...
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MelaFind® - P090012 accessdata.fda.gov
Labeling, Approval Order, and Summary of Safety and Effectiveness for...
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Health Hazard Evaluations & Public Notices and Warnings of Recalls
Health Hazard Evaluation • HHE procedures • Data and factors to...
Recalls from A to Z: Regulations, Decisions, Procedures, & Best Practices -
Elecsys® Anti-HBc IgM Immunoassay and Elecsys® PreciControl Anti-HBc... accessdata.fda.gov
Labeling, Approval Order, and Summary of Safety and Effectiveness for...
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Products and Medical Procedures fda.gov
Recently approved medical device -laboratory test used to detect...
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ADVIA® Centaur Anti-HBs2 (aHBs2) Assay and ADVIA® Centaur Anti-HBs2... accessdata.fda.gov
Labeling, Approval Order, and Summary of Safety and Effectiveness for...
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MelaFind® - P090012 accessdata.fda.gov
Labeling, Approval Order, and Summary of Safety and Effectiveness for...
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Meeting Materials for the Neurological Devices Panel meeting to be... fda.gov
The Neurological Devices Panel reviews and evaluates data concerning...
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MelaFind® - P090012 accessdata.fda.gov
Labeling, Approval Order, and Summary of Safety and Effectiveness for...
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Products and Medical Procedures fda.gov
Elecsys® Anti-HBc IgM Immunoassay and Elecsys® PreciControl Anti-HBc...
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Elecsys® Anti-HBc IgM Immunoassay and Elecsys® PreciControl Anti-HBc... accessdata.fda.gov
Labeling, Approval Order, and Summary of Safety and Effectiveness for...
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Products and Medical Procedures fda.gov
Recently approved medical device -laboratory test used to detect...
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ADVIA® Centaur Anti-HBs2 (aHBs2) Assay and ADVIA® Centaur Anti-HBs2... accessdata.fda.gov
Labeling, Approval Order, and Summary of Safety and Effectiveness for...
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MelaFind® - P090012 accessdata.fda.gov
Labeling, Approval Order, and Summary of Safety and Effectiveness for...
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Federal Register, Volume 77 Issue 24 (Monday, February 6, 2012) gpo.gov
] [FR Doc No: 2012-2583]...
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Federal Register, Volume 77 Issue 24 (Monday, February 6, 2012) gpo.gov
[Federal Register Volume 77, Number 24 (Monday, February 6, 2012)]...
Most Popular Discussions
Vince
- With Executive Signatures
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- We do not Display the Quality Policy
- Other « your vote
Stephen
Greetings Everyone.. hope 2012 is going well for everyone so far!.. Question 21 CFR 820.22 Quality Audit..
Should a firm accomplish a re-certification audit by their recognized registrar would that satisfy the need of not having an annual ...
Francois
FDA Registered and FDA Master File
Can someone tell me if there is really something such as registering medical device material ? Suppliers keep writing this on their ...
David
FDA and industry reach agreement in principle on medical device user fees
The FDA and representatives from the medical device industry have reached an agreement in principle on proposed recommendations for the ...
Press Announcements FDA and industry reach agreement in principle on medical device user fees fda.gov
The FDA and representatives from the medical device industry have reached an agreement in principle on proposed recommendations for the third reauthorization of a medical device user fee program. The recommendations would authorize
David
The U.S. Food and Drug Administration today announced that it has taken action against eight California surgical centers and the marketing firm 1-800-GET-THIN LLC, for misleading advertising of the Lap-Band, an FDA-approved...
David
FDA Medical Device Industry Coalition (FMDIC) is now an open group
I am pleased to announce that, as the owner of this group, I have just switched us to an open discussion group. All future discussions ...
Rekha
If a home monitoring medical device fails to transmit data due to outrage of cellular network. Should it be a considered as a complaint...
If yes, then does a single complaint suffice with the complainant being the first site (medical device used as IDE in a clinical study) ...
David
Rekha
Jamien
MTLI offers this one-day interactive workshop to lead attendees through the regulatory and practical guidelines governing when an IDE is required, how to compile an effective IDE applications, the rules governing clinical studies and human subject protection, Institutional Review Boards, types of pre-IDE meetings and communications, early/expanded access, foreign studies and export, and reimbursem
David
Read about "Use of Red Light Therapy Lamps in Tanning Devices" according to the Texas Department of State Health Services
The Texas Department of State Health Services (Department) has become aware that some tanning facilities have attempted to modify their ...
Tanning Facilities - Drugs and Medical Devices Group dshs.state.tx.us
The role of the Texas Department of State Health Services Drugs and Medical Devices Group in regards to Tanning Facilities is to: A sample Tanning Injury Form can be found at the Tanning Guidance Documents The Texas Department...
Stephen
