February 28, 2020 at 07:31PM In Vitro Diagnostic (IVD) Device Studies - Frequently Asked Questions

This guidance document, written in Q&A, is intended to assist in the development of IVD studies.

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February 28, 2020 at 06:54PM Guidance on Informed Consent for In Vitro Diagnostic Device Studies Using Leftover Human Specimens that are Not Individually Identifiable

FDA intends to exercise enforcement discretion with respect to its current regulations governing the requirement for informed consent when human specimens are..

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February 28, 2020 at 06:19PM Modifications to Devices Subject to Premarket Approval (PMA) - The PMA Supplement Decision-Making Process

The decision-making process in determining the type of regulatory submission required when modifying a lawfully marketed PMA device.

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February 28, 2020 at 05:18PM Bundling Multiple Devices or Multiple Indications in a Single Submission

This guidance is intended to assist industry and FDA staff in understanding when bundling may be appropriate.

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February 28, 2020 at 04:45PM Pharmacogenetic Tests and Genetic Tests for Heritable Markers

Facilitates progress in the field of pharmacogenomics and genetics by helping to shorten development and review timelines, and more.

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February 28, 2020 at 04:36PM Frequently Asked Questions About Medical Devices

Information Sheet Guidance for IRBs, Clinical Investigators, and Sponsors - Frequently Asked Questions About Medical Devices

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February 28, 2020 at 04:20PM Vaccines and Related Biological Products Advisory Committee March 4, 2020 Meeting Announcement - 03/04/2020 - 03/04/2020

This is the main page for the CBER Vaccines and Related Biological Products Advisory Committee March 4, 2020 Meeting Announcement.

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February 28, 2020 at 04:11PM General Principles of Software Validation

General validation principles of medical device software or the validation of software used to design, develop, or manufacture medical devices.

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February 27, 2020 at 06:11PM Nipple Aspirate Test Is No Substitute for Mammogram

Some companies are marketing the nipple aspirate test as the latest and greatest tool in early breast cancer screening. But FDA warns that the nipple aspirate test is no substitute for a mammogram. Find out why.

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February 27, 2020 at 06:11PM In Vitro HIV Drug Resistance Genotype Assay - Class II Special Controls Guidance Document for Industry

This is the Class II Special Controls Guidance Document: In Vitro HIV Drug Resistance Genotype Assay.

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February 27, 2020 at 06:11PM Cord Blood Processing System and Storage Container - Class II Special Controls Guidance for Industry

This is the Guidance for Industry: Class II Special Controls Guidance Document: Cord Blood Processing System and Storage Container

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February 27, 2020 at 06:11PM Automated Blood Cell Separator Device Operating by Centrifugal or Filtration Separation Principle - Class II Special Controls Guidance for Industry and FDA Staff

This is the Guidance for Industry and FDA Staff: Class II Special Controls Guidance Document: Automated Blood Cell Separator Device Operating by Centrifugal or Filtration Separation Principle.

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February 27, 2020 at 05:58PM Consumer Updates

Get timely, reliable, health and safety information about food, drugs, medical devices, vaccines, pet food, pet medicine and more.

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February 27, 2020 at 05:51PM Medication Errors Happen to Pets Too

With pets, as with people, medication errors can happen throughout the treatment process, and your animal's health can be harmed. Learn about the kinds of medication errors that can occur in treating animals, and specific steps you can take to make sure that doesn't happen to your pets.

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