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 Indiana State Library.
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 Indiana State Library.
- Label
- Center for Devices and Radiological Health (U.S.)
- Authority link
- (EG-IN)937073
100+ Items by the Organization Center for Devices and Radiological Health (U.S.)
7 Items that are about the Organization Center for Devices and Radiological Health (U.S.)
Context
Context of Center for Devices and Radiological Health (U.S.)Creator of
- An introduction to medical device regulations
- Annual report
- CDRH FY ... highlights
- CDRH FY ... highlights
- CDRH annual report, fiscal year ..
- CDRH ombudsman annual report
- Evaluation of radiation exposure from diagnostic radiology examinations : general recommendations
- FDA CDRH annual report, fiscal year ..
- FDA's Center for Devices and Radiological Health : a profile
Contributor of
- A Manual on water treatment for hemodialysis
- A follow-up study of persons who had iodine-131 and other diagnostic procedures during childhood and adolescence
- A practitioner's guide to the ultrasonic therapy equipment standard
- An Overview of ultrasound : theory, measurement, medical applications, and biological effects
- An overview of the medical device reporting regulation : final rule, effective December 13, 1984, 21 CFR part 803
- Annual report
- Annual report of the Office of Science and Technology
- Annual reports for approved premarket approval applications (PMA)
- Applications of DNA probes for the diagnosis of human infectious diseases : an overview
- Are routine chest X rays really necessary?
- Assessment and modification of clinical utility in diagnostic radiology : the oral cholecystogram and the upper gastrointestinal examinations
- Basic concepts in the selection of patients for dental X-ray examinations
- Behavioral effects of microwave radiation absorption
- Bundling multiple devices or multiple indications in a single submission
- CSU-FDA Collaborative Radiological Health Laboratory annual report
- Classifying your medical devices
- Compliance guide for laser products
- Computer program for absorbed dose to the breast in mammography
- Condoms and sexually transmitted diseases ... especially AIDS
- Device good manufacturing practices manual
- 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
- Evaluation of radiation exposure from diagnostic radiology examinations : technique/exposure guides for the craniocaudal projection in mammography
- Evaluation of radiation exposure from diagnostic radiology examinations : technique/exposure guides for the dental bitewing projection
- Everything you always wanted to know about the medical device amendments ... and weren't afraid to ask
- Everything you always wanted to know about the medical device requirements-- and weren't afraid to ask
- Export of medical devices : a workshop manual
- Export of medical devices : a workshop manual
- Extremity radiography following trauma : an overview
- 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
- FDA safety alert : defibrillator batteries
- FDA safety alert : for salt tablet users
- 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
- Guide for preparing annual reports on radiation safety testing of laser and laser light show products
- Guide for preparing annual reports on radiation safety testing of mercury vapor lamps
- Guide for preparing annual reports on radiation safety testing of sunlamps and sunlamp products
- Guide for preparing annual reports on radiation safety testing of television receivers
- Guide for preparing annual reports on radiation safety testing of ultrasonic therapy products
- Guide for preparing initial reports and model change reports on lasers and products containing lasers
- 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
- Guideline on general principles of process validation
- Handbook of glandular tissue doses in mammography
- Handbook of selected tissue doses for projections common in diagnostic radiology
- Handbook of selected tissue doses for the upper gastrointestinal fluoroscopic examination
- Have a new medical device? : please notify us!
- Impact resistant lenses : questions and answers
- 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
- Import of medical devices : a workshop manual
- In vitro diagnostic (IVD) device studies, frequently asked questions
- In vitro diagnostic devices : guidance for the preparation of 510(k) submissions
- 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
- Laser light show safety : who's responsible?
- Mammography Matters
- Measurement techniques for use with technique/exposure guides
- Medical device Federal Register documents, June 4, 1976 through April 8, 1986
- Medical device establishment registration : information and instructions
- Medical device problem reporting and the health care professional
- Medical devices bulletin
- 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
- Optical radiation emissions from selected sources
- Orthopaedic device approval and labeling
- Orthopaedic device labeling : guideposts for concerned physicians
- Patient exposure reduction during scoliosis radiography
- Premarket approval (PMA) manual
- Premarket approval application filing review
- 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
- Radiological health bulletin
- Real-time premarket approval application (PMA) supplements
- Recommendations for evaluation of radiation exposure from diagnostic radiology examinations
- Recommendations for quality assurance programs in nuclear medicine facilities
- Reducing patient exposure during scoliosis radiography
- Regulations for the administration and enforcement of the Radiation Control for Health and Safety Act of 1968
- Regulatory requirements for devices for the handicapped
- Reporting guide for laser light shows and displays (21 CFR 1002)
- 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
- Second draft proposed standard for the infant apnea monitor
- Silicone in medical devices : conference proceedings : February 1-2, 1991, Baltimore, Maryland
- The Selection of patients for x-ray examinations : chest x-ray screening examinations
- The Selection of patients for x-ray examinations : presurgical chest x-ray screening examinations
- The Selection of patients for x-ray examinations : skull x-ray examination for trauma
- The selection of patients for X-ray examinations : dental radiographic examinations
- The selection of patients for x-ray examinations : dental radiographic examinations
- The selection of patients for x-ray examinations : presurgical chest x-ray screening examinations
- Therapeutic microwave and shortwave diathermy : a review of thermal effectiveness, safe use, and state of the art, 1984
- Therapeutic microwave diathermy : its safe use
- To cement or not to cement? : or has the FDA approved the use of this device?
- 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
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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.library.in.gov/resource/Cb726rTGd2A/" typeof="Organization http://bibfra.me/vocab/lite/Organization"><span property="name http://bibfra.me/vocab/lite/label"><a href="http://link.library.in.gov/resource/Cb726rTGd2A/">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.library.in.gov/"><span property="name http://bibfra.me/vocab/lite/label"><a property="url" href="http://link.library.in.gov/">Indiana State Library</a></span></span></span></span></div>
