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Annual report

Center for Devices and Radiological Health (U.S.). Office of Science and Technology.
Rockville, Md. : U.S. Food and Drug Administration, Center for Devices and Radiological Health 2001

Annual report of the Office of Science and Technology

Center for Devices and Radiological Health (U.S.). Office of Science and Technology.
Rockville, Md. : U.S. Dept. of Health and Human Services, Public Health Service, Food and Drug Administration, Center for Devices and Radiological Health, [1985]- 2001

Annual reports for approved premarket approval applications (PMA)

Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Devices and Radiological Health : Center for Biologics Evaluation and Research, [2006] 2006

Bundling multiple devices or multiple indications in a single submission

Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Devices and Radiological Health : Center for Biologics Evaluation and Research, [2007] 2007

CDRH FY ... highlights

Center for Devices and Radiological Health (U.S.)
Rockville, Md. : U.S. Department of Health and Human Services, Food and Drug Administration, Center for Devices and Radiological Health, 2005- 2006

CDRH ombudsman annual report

Center for Devices and Radiological Health (U.S.)
Rockville, Md. : Center for Devices and Radiological Health, [2002]- 2001

Draft guidance for HDE holders, institutional review boards (IRBs), clinical investigators, and FDA

[Silver Spring, MD] : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Devices and Radiological Health ; Rockville, MD : Center for Biologics Evaluation and Research, [2008] 2008

FDA and industry actions on premarket approval applications (PMAs), effect on FDA review clock and g

[Rockville, MD] : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Devices and Radiological Health : Center for Biologics Evaluation and Research, [2008] 2008

FDA and industry actions on premarket notification (510(k)) submissions, effect on FDA review clock

Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Devices and Radiological Health : Center for Biologics Evaluation and Research, [2004] 2004

FDA & you

Rockville, Md. : Center for Devices and Radiological Health, 2003-[2009] 2009

FDA CDRH annual report

Center for Devices and Radiological Health (U.S.)
Rockville, Md. : U.S. Department of Health and Human Services, Food and Drug Administration, Center for Devices and Radiological Health 2004

Guidance for clinical trial sponsors establishment and operation of clinical trial data monitoring c

Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research : Center for Drug Evaluation and Research : Center for Devices and Radiological Health, [2006] 2006

Guidance for clinical trial sponsors on the establishment and operation of clinical trial data monit

Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research : Center for Drug Evaluation and Research : Center for Devices and Radiological Health, [2001] 2001

Guidance for industry and FDA staff expedited review of premarket submissions for devices.

Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Devices and Radiological Health : Center for Biologics Evaluation and Research, [2008] 2008

Guidance for industry and FDA staff interactive review for medical device submissions, 510(k)s, orig

[Rockville, MD] : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Devices and Radiological Health : Center for Biologics Evaluation and Research, [2008] 2008

Guidance for industry and staff resolution of disputes concerning payment or refund of medical devic

[Rockville, MD] : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research : Center for Devices and Radiological Health, [2004] 2004

Guidance for industry : complementary and alternative medicine products and their regulation by the

Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research : Center for Drug Evaluation and Research : Center for Devices and Radiological Health : Center for Food Safety and Applied Nutrition, [2006] 2006

Guidance for industry 21 CFR, part 11, electronic records : electronic signatures, electronic copies

Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Office of Regulatory Affairs : Center for Biologics Evaluation and Research : Center for Drug Evaluation and Research : Center for Devices and Radiological Health : Center for Food Safety and Applied Nutrition : Center for Veterinary Medicine, [2002] 2002

Guidance for industry 21 CFR part 11, electronic records, electronic signatures, validation.

Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Office of Regulatory Affairs : Center for Biologics Evaluation and Research : Center for Drug Evaluation and Research : Center for Devices and Radiological Health : Center for Food Safety and Applied Nutrition : Center for Veterinary Medicine, [2001] 2001

Guidance for industry acceptance of foreign clinical studies

[Rockville, MD] : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research : Center for Biologics Evaluation and Research : Center for Devices and Radiological Health, [2001] 2001

Guidance for industry collection of race and ethnicity data in clinical trials.

Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research : Center for Biologics Evaluation and Research : Center for Devices and Radiological Health : Office of the Commissioner, [2005] 2005

Guidance for industry computerized systems used in clinical trials.

[Rockville, MD] : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research : Center for Drug Evaluation and Research : Center for Devices and Radiological Health : Center for Food Safety and Nutrition : Center for Veterinary Medicine : Office of Regulatory Affairs, [1999] 1999

Guidance for industry container and closure system integrity testing in lieu of sterility testing as

Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research, Center for Drug Evaluation and Research, Center for Devices and Radiological Health, Center for Veterinary Medicine, [2008] 2008

Guidance for industry FDA export certificates.

Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research : Center for Drug Evaluation and Research : Center for Devices and Radiological Health : Center for Veterinary Medicine : Center for Food Safety and Applied Nutrition, [2005] 2005

Guidance for industry financial disclosure by clinical investigators.

Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, [2001] 2001

Guidance for industry new contrast imaging indication considerations for devices and approved drug a

Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Office of Combination Products (OCP) in Office of Commissioner : Center for Devices and Radiological Health (CDRH) : Center for Drug Evaluation and Research (CDER), [2008] 2008

Guidance for industry part 11, electronic records : electronic signatures--scope and application.

[Rockville, MD] : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research : Center for Biologics Evaluation and Research : Center for Devices and Radiological Health : Center for Food Safety and Applied Nutrition : Center for Veterinary Medicine : Office of Regulatory Affairs, [2003] 2003

Guidance for industry patient-reported outcome measures, use in medical product development to suppo

Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research : Center for Biologics Evaluation and Research : Center for Devices and Radiological Health, [2006] 2006

Guidance for industry pharmacogenomic data submissions.

Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research : Center for Biologics Evaluation and Research : Center for Devices and Radiological Health, [2005] 2005

Guidance for industry pharmacogenomic data submissions, companion evidence.

Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research : National Center for Toxicological Research : Center for Biologics Evaluation and Research : Center for Devices and Radiological Research, [2007] 2007

Guidance for industry presenting risk information in prescription drug and medical device promotion.

Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, [2009] 2009

Guidance for industry protecting the rights, safety and welfare of study subjects : supervisory resp

Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research : Center for Biologics Evaluation and Research : Center for Devices and Radiological Health, [2007] 2007

Guidance for industry providing regulatory submissions in electronic format, general considerations.

Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research : Center for Drug Evaluation and Research : Center for Devices and Radiological Health : Center for Food Safety and Applied Nutrition : Center for Veterinary Medicine, [2003] 2003

Guidance for industry somatic cell therapy for cardiac disease.

Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research : Center for Devices and Radiological Health, [2009] 2009

Guidance for industry. electronic signatures, scope and application.

Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, [2003] 2003

Guidance for industry : postmarketing adverse event reporting for medical products and dietary suppl

Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Office of Counterterrorism and Emerging Threats : Center for Drug Evaluation and Research : Center for Biologics Evaluation and Research : Center for Devices and Radiological Health : Center for Food Safety and Applied Nutrition, [2008] 2008

Implementation of the Inspection by Accredited Persons Program under the Medical Device User Fee and

Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Devices and Radiological Health : Center for Biologics Evaluation and Research, [2004] 2004

In vitro diagnostic (IVD) device studies, frequently asked questions

Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Devices and Radiological Health : Center for Biologics Evaluation and Research, [2010] 2010

Information sheet guidance for IRBs, clinical investigators, and sponsors frequently asked questions

Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Devices and Radiological Health, [2006] 2006

Information sheet guidance for IRBs, clinical investigators, and sponsors significant risk and nonsi

Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Devices and Radiological Health, [2006] 2006

Modifications to devices subject to premarket approval (PMA) the PMA supplement decision-making proc

[Silver Spring, Md.] : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Devices and Radiological Health ; [Rockville, Md.] : Center for Biologics Evaluation and Research, [2008] 2008

Premarket approval application filing review

[Rockville, Md.] : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Devices and Radiological Health : Center for Biologics Evaluation and Research, [2003] 2003

Premarket approval application modular review

Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Devices and Radiological Health : Center for Biologics Evaluation and Research, [2003] 2003

Premarket assessment of pediatric medical devices

[Rockville, Md.] : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Devices and Radiological Health : Center for Biologics Evaluation and Research, [2004] 2004

Public health notifications

[Rockville, Md.?] : Dept. of Health and Human Services, U.S. Food and Drug Administration, Center for Devices and Radiological Health  

Real-time premarket approval application (PMA) supplements

Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Devices and Radiological Health : Center for Biologics Evaluation and Research, [2006] 2006

Requests for inspection by an accredited person under the Inspection by Accredited Persons Program a

Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Devices and Radiological Health : Center for Biologics Evaluation and Research, [2005] 2004

Use of symbols on labels and in labeling of in vitro diagnostic devices intended for professional us

Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Devises and Radiological Health : Center for Biologics Evaluation and Research, [2004] 2004

User fees and refunds for premarket approval applications

Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Devices and Radiological Health : Center for Biologics Evaluation and Research, [2009] 2009

User fees and refunds for premarket approval applications

Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Devices and Radiological Health : Center for Biologics Evaluation and Research, [2003] 2003