Center for Devices and Radiological Health (U.S.)
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The organization Center for Devices and Radiological Health (U.S.) represents an institution, an association, or corporate body that is associated with resources found in University of Missouri-St. Louis Libraries.
The Resource
Center for Devices and Radiological Health (U.S.)
Resource Information
The organization Center for Devices and Radiological Health (U.S.) represents an institution, an association, or corporate body that is associated with resources found in University of Missouri-St. Louis Libraries.
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- Center for Devices and Radiological Health (U.S.)
75 Items by the Organization Center for Devices and Radiological Health (U.S.)
13 Items that are about the Organization Center for Devices and Radiological Health (U.S.)
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- Draft guidance for HDE holders, institutional review boards (IRBs), clinical investigators, and FDA staff : humanitarian device exemption regulation, questions and answers
- Draft guidance for industry and FDA staff : technical considerations for pen, jet, and related injectors intended for use with drugs and biological products
- Everything you always wanted to know about the medical device requirements-- and weren't afraid to ask
- FDA & you
- FDA and industry actions on premarket approval applications (PMAs), effect on FDA review clock and goals
- FDA and industry actions on premarket notification (510(k)) submissions, effect on FDA review clock and performance assessment
- Guidance for clinical trial sponsors : establishment and operation of clinical trial data monitoring committees
- Guidance for clinical trial sponsors : on the establishment and operation of clinical trial data monitoring committees
- Guidance for industry : "help-seeking" and other disease awareness communications by or on behalf of drug and device firms
- Guidance for industry : 21 CFR part 11, electronic records, electronic signatures, validation
- Guidance for industry : 21 CFR, part 11, electronic records : electronic signatures, electronic copies of electronic records
- Guidance for industry : 21 CFR, part 11, electronic records : electronic signatures, glossary of terms
- Guidance for industry : FDA export certificates
- Guidance for industry : acceptance of foreign clinical studies
- Guidance for industry : collection of race and ethnicity data in clinical trials
- Guidance for industry : complementary and alternative medicine products and their regulation by the Food and Drug Administration
- Guidance for industry : computerized systems used in clinical trials
- Guidance for industry : container and closure system integrity testing in lieu of sterility testing as a component of the stability protocol for sterile products
- Guidance for industry : drugs, biologics and medical devices derived from bioengineered plants for use in humans and animals
- Guidance for industry : electronic signatures, scope and application, Part 11, electronic records
- Guidance for industry : financial disclosure by clinical investigators
- Guidance for industry : new contrast imaging indication considerations for devices and approved drug and biological products
- Guidance for industry : part 11, electronic records : electronic signatures--scope and application
- Guidance for industry : patient-reported outcome measures, use in medical product development to support labeling claims
- Guidance for industry : pharmacogenomic data submissions
- Guidance for industry : pharmacogenomic data submissions, companion evidence
- Guidance for industry : postmarketing adverse event reporting for medical products and dietary supplements during an influenza pandemic
- Guidance for industry : presenting risk information in prescription drug and medical device promotion
- Guidance for industry : protecting the rights, safety and welfare of study subjects : supervisory responsibilities of investigators
- Guidance for industry : providing regulatory submissions in electronic format, general considerations
- Guidance for industry : somatic cell therapy for cardiac disease
- Guidance for industry and FDA staff : expedited review of premarket submissions for devices
- Guidance for industry and FDA staff : interactive review for medical device submissions, 510(k)s, original PMAs, PMA supplements, original BLAs, and BLA supplements
- Guidance for industry and staff : resolution of disputes concerning payment or refund of medical device user fees under MDUFMA
- Guidance for industry, FDA staff, and FDA-accredited third parties, Manufacturer's notification of the intent to use accredited person under the accredited person inspection program authorized by Section 228 of the Food and Drug Administration Amendments Act of 2007 (FDAAA)
- Guide on the use of nuclear medicine instrumentation for measuring environmental radioactivity following a nuclear reactor accident : report of a working group meeting held in Neuherberg, Germany, October 17-21, 1988
- Handbook of selected tissue doses for the upper gastrointestinal fluoroscopic examination
- Implementation of the Inspection by Accredited Persons Program under the Medical Device User Fee and Modernization Act of 2002, accreditation criteria
- Implementing the Mammography Quality Standards Act (MQSA) of 1992 : roles in improving mammography services : conference proceedings, September 20-22, 1993, Reston, Virginia
- Import of medical devices : a workshop manual
- In vitro diagnostic (IVD) device studies, frequently asked questions
- In vitro diagnostic (IVD) device studies, frequently asked questions
- Information sheet guidance for IRBs, clinical investigators, and sponsors : frequently asked questions about medical devices
- Information sheet guidance for IRBs, clinical investigators, and sponsors : significant risk and nonsignificant risk medical device studies
- Mammography Matters
- Medical devices used in home health care
- Medications that increase sensitivity to light : a 1990 listing
- Modifications to devices subject to premarket approval (PMA) : the PMA supplement decision-making process
- Premarket approval application filing review
- Premarket approval (PMA) manual
- Premarket approval application modular review
- Premarket assessment of pediatric medical devices
- Proceedings of the First International Conference of Medical Device Regulatory Authorities (ICMDRA), June 2-6, 1986
- Public health notifications
- Quality assurance guidelines for hemodialysis devices
- Real-time premarket approval application (PMA) supplements
- Requests for inspection by an accredited person under the Inspection by Accredited Persons Program authorized by Section 201 of the Medical Device User Fee and Modernization Act of 2002
- Silicone in medical devices : conference proceedings : February 1-2, 1991, Baltimore, Maryland
- The selection of patients for X-ray examinations : dental radiographic examinations
- Update on possible hazards of traffic radar devices
- Use of symbols on labels and in labeling of in vitro diagnostic devices intended for professional use
- User fees and refunds for premarket approval applications
- User fees and refunds for premarket approval applications
- User fees and refunds for premarket notification submissions (510(k)s)
- Yorick : the CDRH bionic skeleton
- Annual report
- Annual report
- Annual report of the Office of Science and Technology
- Annual reports for approved premarket approval applications (PMA)
- Bundling multiple devices or multiple indications in a single submission
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<div class="citation" vocab="http://schema.org/"><i class="fa fa-external-link-square fa-fw"></i> Data from <span resource="http://link.umsl.edu/resource/Nh7mnujia2U/" typeof="Organization http://bibfra.me/vocab/lite/Organization"><span property="name http://bibfra.me/vocab/lite/label"><a href="http://link.umsl.edu/resource/Nh7mnujia2U/">Center for Devices and Radiological Health (U.S.)</a></span> - <span property="potentialAction" typeOf="OrganizeAction"><span property="agent" typeof="LibrarySystem http://library.link/vocab/LibrarySystem" resource="http://link.umsl.edu/"><span property="name http://bibfra.me/vocab/lite/label"><a property="url" href="http://link.umsl.edu/">University of Missouri-St. Louis Libraries</a></span></span></span></span></div>
