Medical Devices

Office of Science and Engineering Laboratories Final Guidance

This page lists final guidance documents developed by CDRH’s Office of Science and Engineering Laboratories. For a list of current draft guidance documents, please see the Draft Guidance page.

Some Web links (URLs) embedded within guidance documents are no longer valid. If you find a link that does not work, please try searching for the document using the document title.

Office of Science and Engineering Laboratories Final Guidance Documents

TitleOrganizationDoc #Date
Establishing Safety and Compatibility of Passive Implants in the Magnetic Resonance (MR) Environment - Guidance for Industry and Food and Drug Administration Staff (PDF - 224KB) OSEL/DSFM 1685 12/11/14
Radio Frequency Wireless Technology in Medical Devices - Guidance for Industry and Food and Drug Administration Staff CDRH/OSEL CBER 1618 08/14/13
Guidance for Industry and FDA Staff - Investigational Device Exemption (IDE) Guidance for Retinal Prostheses OSEL ODE 1809 03/06/13
Guidance for Industry and FDA Staff - Clinical Performance Assessment: Considerations for Computer-Assisted Detection Devices Applied to Radiology Images and Radiology Device Data - Premarket Approval (PMA) and Premarket Notification [510(k)] Submissions OSEL/DIAM OIVD/DRD 1698 07/03/12
Guidance for Industry and Food and Drug Administration Staff - Computer-Assisted Detection Devices Applied to Radiology Images and Radiology Device Data - Premarket Notification [510(k)] Submissions OSEL/DIAM OIVD/DRD 1697 07/03/12
Guidance for Industry and FDA Staff - Class II Special Controls Guidance Document: Full Field Digital Mammography System OSEL/DIAM OIVD/DRD 1616 03/27/12
Guidance for Industry and FDA Staff - Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers OSEL ODE/DRARD 560 09/09/08
Guidance for Industry and FDA Staff - Class II Special Controls Guidance Document: Bone Sonometers OSEL ODE/DRARD 1547 07/17/08
Guidance for Industry and FDA Staff: Display Accessories for Full-Field Digital Mammography Systems-Premarket Notification (510(k)) Submissions OSEL ODE/DRARD 1617 05/30/08
CDRH Standard Operating Procedures for the Identification and Evaluation of Candidate Consensus Standards for Recognition OSEL 616 09/17/07
Frequently Asked Questions on Recognition of Consensus Standards OSEL 109 09/17/07
Dental Curing Lights - Premarket Notification [510(k)] OSEL/DPS ODE/DAGID/DEDB 1591 03/27/06
Immunotoxicity Testing Guidance OSEL 635 05/06/99
Guidance on FDA's Expectations of Medical Device Manufacturers Concerning the Year 2000 Date Problem OSEL 2000 05/15/98
(Withdrawn) A Primer on Medical Device Interactions with Magnetic Resonance Imaging Systems OSEL 952 02/07/97

Page Last Updated: 12/11/2014
Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.