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Alphabet Soup (U.S. Federal Agencies): CDER: Center For Drug Evaluation and Research; CBER: Center For Biologics Evaluation and Research; CDRH: Center For Devices and Radiological Health; FDA: Food and Drug Administration (part of DHHS); DHHS: Department of Health and Human Services; OHRP: Office For Human Research Protections (part of DHHS); ORI: Office of Research Integrity (part of DHHS); OIG: Office of the Inspector General
Complaints / Concerns About FDA-Regulated Research: Follow this link for things to consider regarding Concerns / Complaints About Research
Complaints / Concerns About FDA-Regulated Products: Follow this link for suggestions about Concerns / Complaints About FDA-Regulated Drugs, Medical Devices, and Dietary Supplements
new FDA Announces Initiative to Facilitate the Development and Availability of Medical Devices. FDA Press Release. 2006-05-22. Available from (External) http://www.fda.gov/bbs/topics/NEWS/2006/NEW01377.html
The Center for Devices and Radiological Health's Medical Device Innovation Initiative. 2006-05. Available from (External) http://www.fda.gov/cdrh/ocd/mdii.html
Guidance for the Use of Bayesian Statistics in Medical Device Clinical Trials – Draft Guidance for Industry and FDA Staff. 2006-05-23. Available from (External) http://www.fda.gov/cdrh/osb/guidance/1601.html
Substantial Equivalence(SE) and for what indication(s).)
Medical Devices to Avoid or to Laugh at and Avoid: FDA Import Alert #89-08 2001-08-13. Detention Without Physical Examination (DWPE) of Class III Devices W/O Approved PMAs or IDEs and Other Devices Not Equivalent of No 510(k). Attachment Revised 2004-02-25. Available from (External) http://www.fda.gov/ora/fiars/ora_import_ia8909.html
Updated Medical Devices to Avoid: FDA Import Alert #89-08 2001-08-13. Detention Without Physical Examination (DWPE) of Class III Devices W/O Approved PMAs or IDEs and Other Devices Not Equivalent of No 510(k). Attachment Revised 2005-12-27. Available from (External) http://www.fda.gov/ora/fiars/ora_import_ia8908.html
This guidance document has a relatively intelligible discussion of
intended use:
Guidance on the CDRH Premarket Notification Review Program 6/30/86 (K86-3). Available from http://www.fda.gov/cdrh/k863.html
Determination of Intended Use for 510(K) Devices; Guidance for CDRH Staff (Update to K98-1.). Available from (External) http://www.fda.gov/cdrh/ode/guidance/857.pdf
When to submit a 510(K) for a change to a medical device (manufacturer responsibility): Deciding When to Submit a 510(k) for a Change to an Existing Device (510(k) Memorandum #K97-1.). Available from (External) http://www.fda.gov/cdrh/ode/510kmod.html
Exhaustively complete information on approval through 510(K) with links:
Premarket Notification 510(k): Regulatory Requirements For Medical Devices (DHHS Publication FDA 95-4158.). Available from (External) http://www.fda.gov/cdrh/manual/510kprt1.html
Great information and easy to understand — once you find it:
FDA Center for Devices and Radiological Health Device Advice. Available from (External) http://www.fda.gov/cdrh/devadvice/
Off Label
vs. investigational use of drugs and devices:
Off-Labeland Investigational Use Of Marketed Drugs, Biologics, and Medical Devices. Information Sheets / Guidance for Institutional Review Boards and Clinical Investigators. 1998 Update. Available from (External) http://www.fda.gov/oc/ohrt/irbs/offlabel.html
FDA Information Sheet Guidance for Institutional Review Boards, Clinical Investigators, and Sponsors: Frequently Asked Questions About Medical Devices. 2006-01. Available from (External) http://www.fda.gov/ohrms/dockets/98fr/06d-0017-gdl0005.pdf
Medical Devices. Information Sheets / Guidance for Institutional Review Boards and Clinical Investigators. 1998 Update. Available from (External) http://www.fda.gov/oc/ohrt/irbs/devices.html
FDA Information Sheet Guidance for Institutional Review Boards, Clinical Investigators, and Sponsors: Significant Risk and Nonsignificant Risk Medical Device Studies. 2006-01. Available from (External) http://www.fda.gov/ohrms/dockets/98fr/06d-0017-gdl0004.pdf
Consumers can search FDA databases to find (expurgated) medical device adverse event reports but keep in mind that not all problems reported are caused by the device. Like the Adverse Event Reporting System (AERS) for drugs, this is a sentinel system that captures adverse events associated with the use of devices as well as adverse events caused by the use of devices.
Monsein, L. Primer on Medical Device Regulation. Radiology. 1997;205:1-9. Available from (External) http://web.archive.org/web/20000423061342/http://www.rsna.org/REG/research/regulatory/monsein1.html . Accessed on 2005-08-31.
OEI-05-94-00100: Investigational Devices: Four Case Studies. Department of Health and Human Services Office of Inspector General. April, 1995. Available from (External) http://oig.hhs.gov/oei/reports/oei-05-94-00100.pdf
(External) Medical Device Acronyms (Unscrambled courtesy of the Food and Drug Law Institute.)
Being updated 2006-06-06. We appreciate your patience.
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