Medical Records Fda

Use of Electronic Health Record Data in Clinical …

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/use-electronic-health-record-data-clinical-investigations-guidance-industry

EHR systems are generally maintained by health care providers, health care organizations, and health care institutions and are used to deliver care. EHR systems …

My Medicine Record | FDA - U.S. Food and Drug …

https://www.fda.gov/drugs/resources-you-drugs/my-medicine-record

My Medicine Record | FDA My Medicine Record This record will help you keep track of your medicines and dietary supplements. Once you have filled out the form, keep a …

MDR Database Search - Food and Drug Administration

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMDR/Search.cfm

MDR Database Search Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products MDR …

Documents, Change Control and Records - Food …

https://www.fda.gov/media/118202/download

“FDA expects that such records will be made available during the course of an inspection. If the foreign manufacturer maintains records at remote locations, such records would be …

Your Medical Records | HHS.gov

https://www.hhs.gov/hipaa/for-individuals/medical-records/index.html

Electronic Source Data in Clinical Investigations | FDA

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/electronic-source-data-clinical-investigations

Center for Biologics Evaluation and Research This guidance provides recommendations to sponsors, Contract Research Organizations (CROs), clinical investigators, and others …

Part 11, Electronic Records; Electronic Signatures

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/part-11-electronic-records-electronic-signatures-scope-and-application

Records submitted to FDA, under predicate rules (even if such records are not specifically identified in Agency regulations) in electronic format (assuming the records have been …

CFR - Code of Federal Regulations Title 21 - Food and …

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=606&showFR=1&subpartNode=21:7.0.1.1.3.9

(a) (1) Records shall be maintained concurrently with the performance of each significant step in the collection, processing, compatibility testing, storage and …

CFR - Code of Federal Regulations Title 21 - Food and …

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCFR/CFRSearch.cfm?CFRPart=820

CFR - Code of Federal Regulations Title 21 FDA Home Medical Devices Databases The information on this page is current as of Jul 20, 2022. For the most up-to …

Search Registration and Listing | FDA

https://www.fda.gov/medical-devices/device-registration-and-listing/search-registration-and-listing

Search the Registration & Listing database Establishment Registration and Medical Device Listing Files for Download Releasable establishment registration and listing information …