FDA Medical Device Regulations and Information

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

Temporary holding: artificial discs.

Generic name: Artificial Cervical Disc System. Trade name: Charité ™ Artificial Disc. Sponsor/Manufacturer: DePuy Spine, Inc. PMA Number: P040006. Date of Notice of Approval to Applicant: 2004-10-26.

Charité ™ Artificial Disc P040006. 2004-10-26. Accessed on 2009-02-14 at: http://www.fda.gov/cdrh/pdf4/P040006.html
FDA CDRH Advisory Committee Orthopedic and Rehabilitation Devices Panel Meeting, 2004-06-02. Accessed on 2009-02-14 at: http://www.fda.gov/ohrms/dockets/ac/cdrh04.html#OrthopaedicandRehabilitation
Charité ™ Artificial Disc P040006 Post-Approval Study: No information; study ordered prior to public database created on 2005-01-01. Accessed on 2009-02-14 at: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMA/pma_pas.cfm
FDA Enforcement Report: No entries. Accessed on 2009-02-14 at: http://www.fda.gov/opacom/Enforce.html
Number of reports returned from FDA MAUDE database for charite received between 2004-01-01 and 2009-01-30: 496. Accessed on 2009-02-14 at: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Search.cfm

Generic name: Artificial Disc System. Trade name: ProDisc®-L Total Disc Replacement. Sponsor/Manufacturer: Synthes Spine. PMA Number: P050010. Date of Notice of Approval to Applicant: 2006-08-14.

ProDisc®-L Total Disc Replacement P050010. 2006-08-14. Accessed on 2009-02-14 at: http://www.fda.gov/cdrh/pdf5/P050010.html
Advisory Committee: NA
FDA Enforcement Report: No entries. Accessed on 2009-02-14 at: http://www.fda.gov/opacom/Enforce.html
ProDisc®-L Total Disc Replacement P050010 Post-Approval Studies. Accessed on 2009-02-14 at: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMA/pma_pas.cfm?c_id=56&t_id=350789
Number of reports returned from FDA MAUDE database for prodisc-l received between 2004-01-01 and 2009-01-30: 3. Accessed on 2009-02-14 at: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Search.cfm
Clinical trial sites: http://tinyurl.com/azoldm

Generic name: Artificial Cervical Disc System. Trade name: Prestige® Cervical Disc System. Sponsor/Manufacturer: Medtronic Sofamor Danek. PMA Number: P060018. Date of Notice of Approval to Applicant: 2007-07-16.

Prestige® Cervical Disc System P060018. Accessed on 2009-02-14 at: http://www.fda.gov/cdrh/pdf6/p060018.html
FDA CDRH Advisory Committee Orthopedic and Rehabilitation Devices Panel Meeting, 2006-09-19. Accessed on 2009-02-14 at: http://www.fda.gov/ohrms/dockets/ac/cdrh06.html#orthopaedic
Prestige® Cervical Disc System P060018 Post-Approval Studies. Accessed on 2009-02-14 at: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMA/pma_pas.cfm?t_id=371008&c_id=122
FDA Enforcement Report. 2007-12-26. Accessed on 2009-02-14 at: http://www.fda.gov/bbs/topics/ENFORCE/2007/ENF01036.html
Number of reports returned from FDA MAUDE database for prestige cervical disc received between 2004-01-01 and 2009-01-30: 6. Accessed on 2009-02-14 at: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Search.cfm
Ulatowski T. FDA Warning Letter to Mark Adams, M.D. 2008-01-23. Accessed on 2009-02-14 at: http://www.fda.gov/foi/warning_letters/archive/s6652c.pdf

Generic name: Artificial Cervical Disc System. Trade name: ProDisc®-C Total Disc Replacement. Sponsor/Manufacturer: Synthes Spine. PMA Number: P070001. Date of Notice of Approval to Applicant: 2007-12-17.

ProDisc®-C Total Disc Replacement P070001. 2007-12-17. Accessed on 2009-02-14 at: http://www.fda.gov/cdrh/pdf7/P070001.html
Advisory Committee: NA
FDA Enforcement Report: No entries. Accessed on 2009-02-14 at: http://www.fda.gov/opacom/Enforce.html
ProDisc®-C Total Disc Replacement P070001 Post-Approval Studies. Accessed on 2009-02-14 at: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMA/pma_pas.cfm?c_id=163&t_id=382238
Number of reports returned from FDA MAUDE database for prodisc-c received between 2004-01-01 and 2009-01-30: 14. Accessed on 2009-02-14 at: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Search.cfm
Clinical trial sites: http://tinyurl.com/cxeeoc

Errata, Artificial Spinal and Cervical Discs.

[Device and Sponsor Unknown] Ulatowski T. FDA Warning Letter to Michael E. Janssen, D.O. 2007-07-03. Accessed on 2009-02-14 at: http://www.fda.gov/foi/warning_letters/archive/s6435c.pdf

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

FDA Announces Initiative to Facilitate the Development and Availability of Medical Devices. FDA Press Release. 2006-05-22. Available from 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 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 http://www.fda.gov/cdrh/osb/guidance/1601.html

Basic Information About Medical Devices

• FDA Center For Devices and Radiological Health Consumer Resources   (Possibly the best straightforward introduction to the regulation of medical devices.)
• Devices@FDA Search   (510(K), PMA, and HDE.)
• 510(K) Database Search   (Find out if a device is approved for marketing on the basis of Substantial Equivalence (SE) and for what indication(s).)
• Device Listing Database Search   (Foreign and domestic devices in commercial distribution.)
• Humanitarian Use Devices   (List of designated devices and summaries of safety and possible benefit.)
• Humanitarian Device Exemptions (HDE) Regulation   (Questions and Answers Final Guidance for Industry.)
• IDE Policies and Procedures   (Comprehensive information on Investigational Device Exemption submission.)
• PMA Post Approval Studies
• CLIA — Clinical Laboratory Improvement Amendments

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 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 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 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 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 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 http://www.fda.gov/cdrh/devadvice/

Off Label vs. investigational use of drugs and devices:

Off-Label and Investigational Use Of Marketed Drugs, Biologics, and Medical Devices. Information Sheets / Guidance for Institutional Review Boards and Clinical Investigators. 1998 Update. Available from 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 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 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 http://www.fda.gov/ohrms/dockets/98fr/06d-0017-gdl0004.pdf

Medical Device Adverse Events

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.

• MAUDE Search.   (Manufacturer and User Facility Device Experience. 1996-07 and later.)
• MAUDE Advanced Search
• MDR Search.   (Medical Device Adverse Event Reporting Data Files Search. 1996-07 and earlier.)
• MDR Advanced Search
• CDRH User Facility Reporting Bulletins
• Medical Device Recalls

Devices: Medical Tests

• Clinical Laboratory Improvement Amendments (CLIA).   (Guidance for Administrative Procedures for CLIA Categorization. Draft of 2000-08-14.)
• CLIA Search

• Office of In Vitro Diagnostic Device (OVID) Evaluation and Safety Evaluation and Safety Main Page
• OVID Search.   (IVD Over the Counter (OTC) Database.)

Device Advisory Committees

• FDA CDRH Advisory Committee Database
• FDA CDRH Advisory Committee Transcripts   (Older)
• Federal Advisory Committee Database

Medical Device Reporting (MDR)

• Medical Device Reporting is FDA–speak for medical device serious adverse event reporting. FDA collected the MDR notices published in the Federal Register between 1991 and today and published them at this URL: http://www.fda.gov/cdrh/mdr/frmdr.html

Additional Device Information

Monsein, L. Primer on Medical Device Regulation. Radiology. 1997;205:1-9. Available from 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 http://oig.hhs.gov/oei/reports/oei-05-94-00100.pdf

Medical Device Acronyms   (Unscrambled courtesy of the Food and Drug Law Institute.)

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FDA Regulations

Being updated 2006-06-06. We appreciate your patience.

• FDA Unified Agenda of Federal Regulatory and Deregulatory Actions

• Federal Register, Database Search   (GPOAccess.)
• Electronic Code of Federal Regulations (e-CFR)   (Beta test site.)
• Code of Federal Regulations Title 21 Database Search

• United States Code Database search.   (GPOAccess.)
• United States Code Title 21 Food and Drugs, Chapter 9, Federal Food, Drug, and Cosmetic Act.   (GPOAccess.)

Additional FDA Resources

• Index of FDA Databases
• FDA News Release Index (1987- )
• FDA Health Fraud Directory
• Search the FDA Web site
• FDA Public Calendar.   (The FDA Public Calendar has reports of meetings held by FDA policy makers with persons outside the executive branch of the Federal government.)

Additional Information

• CIRCARE FDA Research Regulations and Information
• CIRCARE Drug Information Page
• Newark Star Ledger's multi-part series on medical devices   (Requires free registration.)

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