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Center for Devices and Radiological Health 2001

Center for Devices and Radiological Health 2001

Chapter 2

Last Update: August 07, 2003

Bioresearch Monitoring

FDA Inspection Finds Violations at Cosmetic Surgery Center

Clinical Investigator Warned for Failure to Obtain Informed Consent as Required by FDA Regulations

On October 23, 2000, the FDA's Center for Devices and Radiological Health (CDRH) issued a Warning Letter to R. McIntiyre Bridges, M.D., Bridges to Beauty Center for Cosmetic Surgery, Shreveport, Louisiana. The FDA conducted an inspection of the facility from July 25 - 27, 2000. The inspection was conducted to determine if Dr. McIntiyre Bridges activities as a clinical investigator complied with FDA regulations and to ensure that the information contained in the requests for Investigational Device Exemptions, Premarket Approval Applications, and Premarket Notifications were scientifically valid and accurate. In addition, the inspection was conducted to ensure that human subjects were protected from undue hazards or risks during the course of the clinical study.

FDA's inspection revealed serious violations of FDA regulations as contained Title 21 Code of Federal Regulations Part 50 - Protection of Human Subjects and Part 56 - Institutional Review Boards. The deviations noted during the inspection and cited in the Warning Letter included: failure to obtain informed consent per 21 CFR 50.20 and failure to obtain approval from the Institutional Review Board prior to changes or deviations in the study protocol.

Warning Letter Issued to Monitor of Clinical Study

Investigator Fails to Obtain IRB or FDA Approval Prior to Initiating Investigational Study

On August 21, 2001, the FDA's Center for Devices and Radiological Health issued a Warning Letter to Meredith Rigdon Lentz, M.D., Lentz Apheresis Center, Nashville, Tennessee. The Warning Letter was a result of an inspection conducted by FDA's New Orleans District Office Nashville Branch. The inspection was conducted from March 5 - May 10, 2001, and revealed serious deficiencies regarding Dr. Lentz activities as a sponsor/monitor of investigational studies of apheresis devices.

These deficiencies included the following: failure to obtain FDA or IRB approval prior to treating human subjects with investigational medical devices; failure to obtain approval of a supplemental application prior to implementing protocol changes; and failure to submit and obtain approval of a supplemental application prior to implementing a change to an investigational plan; failure to ensure that the requirements for obtaining informed consent were met; failure to conduct the investigations in accordance with the investigational plans, other applicable regulations and conditions of approval imposed by an IRB or FDA; failure to maintain accurate, complete, and current records relating to the investigations; failure to have adequate written monitoring procedures, select qualified monitors, and monitor the clinical investigations in accordance with federal regulations.

FDA Issues Warning Letter to Institutional Review Board

Clinical Investigator Fails to Personally Supervise Clinical Trial

On March 7, 2001, the FDA's Center for Device Evaluation and Research issued a Warning Letter to St. Mary's Medical Center Institutional Review Board (IRB), San Francisco, California. The Warning Letter was based on an FDA inspection from October 12 through 24, 2000. The Warning Letter cited the following violations of FDA regulations: (1) failure to follow written procedures for Institutional Review Board (IRB) functions and operations; (2) failure to maintain records of the IRB functions and activities; and (3) failure to provide a procedure that describes how the IRB will determine which device studies are significant risk or non-significant risk. Observations noted during the FDA inspection included failure by the IRB to take prompt action concerning a sponsor-initiated suspension of a principal investigator. In addition, no documentation was available to show the number of members voting for, against, and abstaining from voting at IRB meetings.

Community Hospital Receives Warning Letter

IRB Fails to Review Research In Accordance with FDA Regulations

On June 28, 2001, CDRH issued a Warning Letter to the President of Bayshore Community Hospital, Holmdel, New Jersey. FDA issued the Warning Letter following an inspection of the Institutional Review Board at the Bayshore Hospital on April 23 - 24, 2001. The violations of the FDA regulations included: written procedures did not adequately meet the FDA regulatory requirements; the Institutional Review Board (IRB) failed to conduct review of research in accordance with the IRB's written procedures. In addition, the IRB failed to maintain minutes of the IRBÂ’s meetings in sufficient detail to show attendance at the meetings, actions taken by the IRB, the vote on these actions including the number of members voting for, against and abstaining as required by FDA regulations.

FDA Investigation Finds Objectionable Conditions at Clinical Site

On April 27, 2001, the Center for Devices and Radiological Health issued a Warning Letter to Donald R. Johnson, M.D., Clinical Investigator, Carolina Spine Institute, Mt. Pleasant, South Carolina. The Warning Letter was issued based on objectionable conditions observed by FDA investigators during an inspection from February 14 - 22, 2000.

The following violations of federal regulations were detailed in the Warning Letter: failure to prepare and submit complete, accurate, and timely reports of unanticipated adverse device effects; failure to conduct an investigation in accordance with the investigational plan; and failure to submit to the Institutional Review Board for review and approval changes in the investigational plan.

Cardiovascular

Manufacturer of Cardiac Balloon Catheters Receives Warning

The FDA's New Jersey District Office issued a Warning Letter on February 15, 2001, to the Assistant General Manager and Co-Owner of J-Lloyd Medical, Inc., West Berlin, New Jersey. The firm is a manufacturer of cardiac balloon catheters. The Warning Letter cited the firm for serious deviations from the Quality System Regulation for medical devices based on observations made during an inspection of the firm on December 12 - 20, 2000. Some of these deviations included the following: failure to implement design controls when the design of the pacing catheters was changed to include shrouds on the patient leads. Additional problems were noted in design controls, design validation, failure to establish written Medical Device Reporting (MDR) procedures, and failure to document post-sterilization seal integrity testing of the catheter packages.

Firm Recalls Defibrillator

Defibrillator Recalled Due to Potential to Shut Down

The FDA's New England District Office reported that on February 5, 2001, Agilent Technologies, Inc., Andover, Massachusetts, initiated a voluntary recall for the Agilent Model M3500B Heartstream XLT Defibrillator. The defibrillator is also labeled as: Laerdal Heartstart, 4000 Model, M5500B, Defibrillator/Monitor, S/N range: US00100100-US101521B; Heartstream, XL Model, M4735A, Defibrillator/ Monitor S/N range: US00100100-US00100778.

The reason for the recall was that the Heartstream XLT (also known as Laerdal Heartstart 4000) and the Heartstream XL might shut down or fail to power on due to a failure of a component on the printed circuit board. There was no warning this event may occur. The firm confirmed 6 failures among 1200 in the Heartstream XLT and 1 failure in approximately 500 of the Heartstream XL units distributed. Agilent Technologies, Inc., notified consignees on February 5, 2001, to advise them of the problem and suggested using an alternate defibrillator until repair occurs. Written procedures were provided titled " Procedures to Mitigate Risk". An Agilent Representative visited each account within 4-6 weeks to schedule repair, while the firm was in the process of producing printed circuit boards with a new component.

Implantable Cardioverter Defibrillator Recalled

On February 5, 2001, Angeion Corporation, St. Paul., Minnesota, recalled the ELA/Angeion Lyra Implantable Cardioverter Defibrillators. Z-251-Model No. 2020; Z-252-Model No. 2021; Z-253-Model No. 2022. Codes: Model No. 2020; Model No. 2021; Model No. 2022. Angeion is the manufacturer of the defibrillator. The recall included the United States, Europe and South America. The recall was based on the fact that the device could fail to provide pacing or defibrillation therapy. Four-hundred ninety four defibrillators were involved in the recall.

Three Former Executives of C.R. Bard Sentenced

Executives Enter Plea Agreement Following Circuit Court Reversal of District Court Decision

On June 8, 2001, three former executives with C.R. Bard Co., David Prigmore, John Cvinar, and Lee Leichter, pleaded guilty to a misdemeanor count of shipping adulterated catheters. Previously, the three executives were sentenced to18 months in prison. However, they subsequently appealed their case and the First Circuit Court of Appeals reversed the District Court decision, based on an improper jury instruction, and remanded the case for further proceedings.

In lieu of a new trial, a plea agreement was reached, thereby concluding this case. The judge sentenced the defendants to one-year probation, including 8 months of home confinement plus a fine. In 1995, the Corporation had pled guilty to 393 felony counts and paid a $60 million penalty, at the time the largest ever imposed in a health care fraud case. The corporate settlement is not affected by the recent plea agreement and sentencing.

Dental

FDA Assists U.S. Customs in Seizure

The FDA's Import Operations Branch New York District and representatives of the U.S. Customs Service at JFK International Airport in a collaborative endeavor intercepted a shipment of 1,506 cases of Colgate toothpaste. The Importer of Record affiliated with the shipment was Red Coast Imports of Lachine Canada and the consignee was ETC Company of Bohemia, New York. The original transmission on November 20, 2000, reflected the country of origin as the United States and employed a product code which indicated the product was toothpaste without fluoride. Therefore, the article was issued a May Proceed.

However, when U.S. Customs Service initiated an examination of the shipment they discovered toothpaste with Russian language and that it contained fluoride. Thereafter, FDA rescinded the May Proceed and issued a notice of detention and subsequent refusal. The United States Customs Service then seized the article.

Warning Letter Issued to Dental Manufacturer

Violations of Quality System Regulation Result in Warning Letter

On September 10, 2001, the FDA's Chicago District Office issued a Warning Letter to Lang Dental Manufacturing Co., Inc., located in Wheeling, Illinois. The firm manufactures dental acrylics, resins, and reliners. The letter cited the firm for Quality System deficiencies in the following areas: failure to develop, conduct, control, and monitor processes to ensure that a device conforms to its specifications; failure to maintain the Device Master Record and Device History Records for Flexacryl; failure to establish and maintain corrective and preventive action procedures; and failure to establish medical device reporting procedures.

General Hospital and Personal Use

FDA Inspection Finds Problems With Basic Life Support Equipment

Warning Letter Cites Numerous CGMP Violations of The Quality System Regulation

On May 23, 2001, the FDA's Center for Devices and Radiological Health issued a Warning letter to the Managing Director, President and Chief Executive Office, of Laerdal Medical AS, Stavanger, Norway. An inspection of the firm located in Stavanger, Norway, on February 5 - 8, 2001, determined serious problems in the manufacture of suction pumps, suction units, Laerdal suction units, face shields, pocket masks, resuscitators, and other basic life support equipment.

The Warning Letter cited the following CGMP deviations: failure to establish and maintain adequate procedures for finished device acceptance; failure to establish and maintain adequate procedures for receiving, review and evaluation of complaints; failure to establish and maintain adequate procedures for implementing corrective and preventive action; failure to establish and maintain adequate procedures that define the responsibility for review and the authority for disposition of nonconforming product; failure to establish and maintain procedures for identification, documentation, validation of design changes before their implementation; and finally, failure to establish procedures for identifying training needs.

Warning Issued to Manufacturer of Thrombectomy Catheter Systems

On March 9, 2001, the FDA's Minneapolis District Office issued a Warning Letter to the President and CEO of Possis Medical, Inc., Minneapolis, Minnesota. The Warning Letter was based on violations of the Quality System Regulation (QSR) observed during an FDA inspection of the firm from January 4 - February 7, 2001. The firm manufacturers thrombectomy catheter systems. The CGMP deviations from the QSR included: failure of management with executive responsibility to ensure that an adequate and effective quality system was fully implemented and maintained; failure to provide adequate resources for performing and assessment activities; failure to implement procedures for corrective and preventive actions; and failure to fully investigate a complaint.

Other deviations noted during the inspection included: process validation activities were not complete and/or the results were not fully documented; procedures for monitoring and control of a validated process were incomplete and failed to ensure that specified requirements were consistently met; and review of sampling methods for adequacy for their intended use was not documented.

Florida District Issues Warning Letter to Device Firm

Warning Letter Cites 11 Violations of the Quality System Regulation

The FDA's Florida District Office issued a Warning Letter on March 7, 2001, to the President of Safety Disposal System, Miami Lakes, Florida. The Warning Letter cited violations of the Quality System Regulation (QSR) found during an inspection of the firm on January 10-12, and 16, 2001. The firm is a specification developer, reprocessor and distributor of reusable sharps containers. The Warning Letter noted the following violations: failure to conduct management review covering the overall suitability of a quality system as required by FDA regulations; failure to conduct quality audits that address all quality system requirements; failure to establish and maintain procedures for implementing corrective and preventive action; failure to validate the cleaning and disinfection processes of the reprocessing operation; among others. In total, the Warning Letter listed 11 violations of the QSR.

Firm Fails to File Device Injury Report

The FDA's New Orleans District Office/Nashville Branch issued a Warning Letter on March 12, 2001, to University of Tennessee Bowld Hospital, Memphis, Tennessee. An FDA inspection of the facility on February 21 - 23, 2001, revealed that the firm failed to submit Medication and Device Experience Reports for serious injury to patients during treatment with a device.

Warning Letter Issued for Umbilical Cord Clamps

Firm Warned for Failure to Establish And Implement a Quality System

On June 8, 2001, the FDA's New Jersey District Office issued a Warning Letter to Prosec Security Systems, Inc., in Lakewood, New Jersey. The firm is a manufacturer, repacker and sterilizer of umbilical cord clamps with a security transponder. An FDA inspection of the firm on May 10 and 11, 2001, revealed deviations from the Quality System Regulation. The Warning Letter identified the following violations: failure to establish and implement a quality system; failure to have design control procedures in place; failure to have an assurance that the sterilization processes utilizing ethylene oxide and hydrogen peroxide are effective for the product and packaging; failure to establish and monitor environmental conditions; and failure to have a documented training program to assure that employees have the knowledge and training to adequately perform their assigned duties.

Previously, on September 1, 2000, the Prosec Protection Systems initiated a nationwide recall of the Infant Umbilical Clamp with Security Transponder Device. The device was recalled because the clamp sometimes slipped off and could lead to infection (skin and Bacteria) and blood loss.

Problems with Respirometers and Peak Flow Meter Result in Warning

FDA Inspection Discloses Problems with Device Design and Development

On February 9, 2001, the FDA's Center for Devices and Radiological Health issued a Warning Letter to the Managing Director of Ferraris Medical Ltd, London, United Kingdom. An FDA inspection of the firm from October 30 - November 2, 2000, revealed serious regulatory problems involving the firms respirometers and peak flow meters. The following deviations from the Quality System Regulation (QSR) were noted in the Warning Letter: failure to establish and maintain procedures for the identification, documentation, validation, review and approval of design changes before their implementation; failure to establish design input; failure to establish and maintain procedures for validating the device design before implementation; failure to maintain procedures for design review to ensure that formal documented reviews of the design results are planned and conducted at appropriate stages of the design development; failure to verify and document the device design, among others. In total, the Warning Letter cited 10 violations of the QSR.

Destruction of Imported Medical Devices

The FDA's Chicago District Offices Import Team witnessed the destruction of two medical device shipments. The first shipment consisted of 33 packages of first aid kits from Germany that had been refused entry for not being listed and for the initial distributor not being registered. The second shipment consisted of 141 cases of sutures which had been returned from Japan. The products were refused and destroyed for not being listed and not having pre-market notification. The shipments had a combined valued of $27,000.00.

Glucose Monitoring Device Recalled

On November 3, 2000, Lifescan, Inc., Milpital, California, initiated a recall of the FastTake Compact Blood Glucose Monitoring System. The monitoring device is used to quantitatively measure glucose (sugar) levels in whole blood taken during home-care use. The product is manufactured under the following trade names: One Touch FastTake Compact Blood Glucose Monitoring System (in the U.S. and Canada); PocketScan Compact Blood Glucose Monitoring System (in the United Kingdom); EuroFlash Compact Blood Glucose Monitoring System (in Europe); SmartScan Compact Blood Glucose Monitoring System (in Asia, Middle East, Africa, Europe).

The recall involved all meters with serial numbers starting with K, L, M and N. The device is manufactured by Inverness Medical, Inc., Waltham, Massachusetts. The firm initiated the recall because the meter might display a "y" character instead of a number in the test result.

Class I Recall of Ventilator

On December 22, 2001, Puritan-Bennett Corporation, Carlsbad, California, initiated a recall of 656 of the Puritan Bennett® Model 840 Series Ventilator System, All Serial Numbers with Revision E Level Software. The device is used to mechanically control or assist a patients breathing by delivering a predetermined percent of oxygen in breathing gases. This device is used in hospital facilities. Distribution of the product was both nationwide and International. The reason for the recall was that the Ventilator System could malfunction which could result in over pressure and barotrauma - thus leading to serious injury or death in patients whose body weight is less than 20 kg.

FDA Witnesses Destruction of Imported Device

On July 24, 2001, the FDA's Chicago District Office witnessed the destruction of an MIE Respirometer in Chicago, Illinois. The respirometer had been imported from Great Britain and was refused entry because it was not device listed and the importer was not registered as an initial distributor of medical devices. The respirometer was valued at $4,100.

General and Plastic Surgical

Recall of Disposable Scalpels

Packaging Defects Compromise Sterility of Scalpels

The FDA's New York District Office reported that ZNC International, Port Chester, announced a recall of disposable scalpels. On June 22, 2001, ZNC International informed the FDA's New York District Office of their intention to recall various sizes of disposable scalpels due to the potential for packaging defects that could compromise the sterility of the product.

The scalpels were imported from India, and labeled as sterile. The recall involved five lots shipped to ZNC International in November 2000. ZNC's recall involved 1,100 boxes of scalpels shipped to approximately 14 distributors. Recall letters issued on/about June 25, 2001. The supplier in India had changed the packaging of the scalpels to include a three-point weld. Shipments received by ZNC after the November 2000 shipment were not affected by the recall.

Firm Recalls Microvasive Inflators

The FDA's New England District Office reported that Boston Scientific Corp., One Boston Scientific Place, Natick, Massachusetts, recalled the following: A) Microvasive LeVeen Inflator with Pressure Gauge 20 ml (cc), Catalog #710-112; B)Medi-Tech LeVeen Inflator with Pressure Gauge 20 ml (cc), Catalog #115-102; and C) Microvasive Balloon Dilatation Catheter Kits containing the Microvasive LeVeen Inflator with Pressure Gauge 20 ml (cc), Catalog #710-112. This Class II Recall was initiated because the sterility of the device may have been compromised due to a loss of package integrity.

Class 1 Recall of Gelfoam Sterile Powder and Sponge

On November 22, 2000, the FDA announced the recall of Gelfoam Sterile Power and Sponge. The product is used for application to bleeding surfaces to slow and stop the flow of blood. This product is used by physicians during surgical procedures to control bleeding when applying pressure or tying-off blood vessels is ineffective or impractical. The product was recalled because metal (aluminum) shavings were found inside bottles of the product. This occurred due to a design fault of the lid where the removal or resealing of the product caused the shavings of aluminum to fall into the bottles contents. The recalling firm was Pharmacia Corporation, Kalamazoo, Michigan. The FDA considers there to be a risk of local fibrosis (thickening or scarring of the tissue) and infection from the use of this product.

Class I Recall of Absorbable Hemostatic Agent

On January 19, 2001, the FDA announced a recall of Adcon-L and Adcon-T/N Sterile Absorbable Hemostatic Agent. The product is used in single-level, posterior, lumbar disk surgeries (laminectomy) where nerve roots are exposed. It is used to inhibit post-surgical peridural fibrosis (thickening and scarring of the tissue surrounding the disks of the spine). This device is used by physicians during surgical procedures. It is not a consumer Product. The recalling firm is Gliatech, Inc, Cleveland, Ohio.

The reason for the recall was that aluminum particles were seen in jars of Gelfoam ( raw material component recalled on November 12, 2000, by its manufacturer, Pharmacia Corporation) used to manufacture Adcon-L and Adcon-L T/N Sterile Absorbable Hemostatic Agent. The particles came from the aluminum lid liner of the containers of Gelfoam and fell into the bottle when the lid was opened or resealed. The FDA considers there to be a risk of post operative infections and post operative pain.

Seizure of Circumcision Clamps

Clamp Malfunction Leads to Seizure of Device

On April 19, 2001, the FDA's Chicago District Office accompanied the U.S. Marshals Service in a seizure involving 2,000 circumcision clamps valued at approximately $70,000 at Medco Instruments, Inc., Crestwood, Illinois. Prior to this seizure, the Chicago District Office issued a Warning Letter to the firm on June 9, 2000. The Warning Letter was based on an inspection conducted from January 11 to February 8, 2000, to determine the cause of injuries associated with circumcision clamps imported by Medco Instruments, Inc. The Chicago District investigators determined that neither Medco nor its Pakistani contract manufacturers had submitted a 510 (k) premarket notification for the circumcision clamps.

Chicago District Office investigators documented 8 Medical Device Reporting (MDR)-Reportable [unreported by Medco] complaints of clamp malfunction, dating from October 1996 to May 1999. Seventy-five percent of the MDR-Reportable events involved infants who required surgical intervention to mend their injuries. In February 1999, Medco removed 783 circumcision clamps from the market in response to complaints from the distributor, Allegiance Healthcare, McGaw Park, Illinois. Medco failed to report this correction/removal to FDA. In addition, the firm failed to document investigation of complaints involving product failures. Medco lacked MDR-Reporting procedures, corrective and preventive action procedures, calibration/maintenance procedures (for calipers used in finished inspection), design specifications, and labeling specifications.

In response to the Warning Letter Medco recalled all clamps and agreed to stop distribution. However, the firm later decided to attempt to return the recalled clamps to their Pakistani contract manufacturers for credit. To prevent redistribution of these circumcision clamps, the FDA determined that seizure was the appropriate course of action.

The seizure action went into default and on July 18, 2001, the U.S. District Court ordered the clamps destruction. On August 14, the U.S. Marshals Service transported all circumcision clamps to Duroweld, Inc., Lake Bluff, Illinois. Duroweld volunteered to destroy the clamps, document their destruction with photographs, and certify completion. Duroweld performed the destruction by smashing each clamp in their press and then submitted the scrap metal for recycling. The clamps are chrome-plated brass.

Clinical Resources International Enjoined

Continuing Noncompliance with Quality System Regulation Leads to Injunction

U.S. v. Clinical Resources International, Inc., and Gerald A. Miller and Donald W. Larson (S.D. Iowa). On November 15, 2000, District Court Judge Robert W. Pratt entered a Consent Decree of Permanent Injunction in this case. The firm manufacturers sterile general surgical convenience kits and wound care kits and has had a chronic problem with compliance with the Quality System Regulation.

Pursuant to the decree, Clinical Resources will submit to FDA an amendment to its registration to reflect that it will only hold, store, and distribute articles of device. The defendants are enjoined from manufacturing, packing, or labeling any article of device until an expert certifies that they are in compliance with the decree, the Act, CGMP, and FDA regulations, FDA inspects the defendants' facilities, and notifies defendants in writing that they appear to be in compliance. If defendants resume the manufacturing, processing, packing, or labeling of devices, the decree requires audits of their operations (at least two every 12 months) over a period of 36 months.

In addition, the defendants may not distribute any articles of device in their possession, custody, or control until the articles have been reconditioned pursuant to a plan approved by FDA, an expert certifies that the articles have been brought into compliance, and FDA notifies defendants in writing that they may distribute the articles. The decree also provides for letter shutdown and recalls. All FDA decisions made pursuant to the decree will be reviewed under the arbitrary and capricious standard.

Internet Enforcement Activities

Warning Letter Issued for Promotion of Silicone for Unapproved Use

Firm Warned for Internet Promotion of Silicone for Skin Defects

On October 5, 2000, the FDA's Center for Devices and Radiological Health issued a Warning Letter to David J. Naris, M.D., The Dermatology Surgery and Laser Center, White Plains, New York. The Warning Letter advised Dr. Naris that FDA's review of his Website for the Adatomed Silicone Oil determined that the Website promoted Adatomed Silicone as a treatment for skin defects such as wrinkles or scars. These uses have not been approved by FDA. Therefore, the promotion of Adatomed Silicone for the treatment of skin defects such as wrinkles and/or scars, or as a permanent filling substance to treat skin folds or depressions, is a violation of the law.

On November 4, 1994, the FDA approved Adatomed Silicone through the Premarket Approval process for use as a prolonged retinal tamponade in selected cases of complicated retinal detachments where other interventions are not appropriate for patient management. Although physicians may use a legally marketed medical device to treat patients for any intended use that he/she desires within the bounds of his/her state licensing requirements, a licensed practitioner may not promote that medical device for use(s) that have not been approved by FDA.

FDA Investigation Finds Investigational Device Promoted on Internet

Clinical Investigator Warned for Promoting an Investigational Device on the Internet

On January 25, 2001, the FDA's Center for Devices and Radiological Health issued a Warning Letter to Jerry I. Jacobson, D.D.S., D.M.D., Chair, CEO, and President, Jacobson Resonance Enterprises, Inc., Boynton Beach, Florida. The Warning Letter was based on information obtained during an inspection of the facility on September 11 - 15, 2000.

During the inspection FDA investigations noted the following violations of FDA regulations: failure to ensure proper monitoring of a clinical investigation; failure to comply with prohibitions against promotion and other practices. The Warning Letter noted that Misleading and/or inaccurate statements pertaining to the device and related studies were observed in various materials: a brochure, subject recruiting advertisements; and press releases and other information distributed via the internet... The Warning Letter advised that a sponsor or investigator, or any person acting on their behalf, is prohibited from promoting or test marketing an investigational device until after FDA has approved the device for commercial distribution.

Warnings Issued for Unapproved Devices Promoted on Web

On May 31, 2001, the Center for Devices and Radiological Health issued a Warning Letter to Kyle Creasy, President, KCC Enterprises, Orlando, Florida. The FDA issued the Warning Letter for the promotion of a product known as the Instant Drug Test, made and marketed by KCC Enterprises. The product was promoted for use to diagnose or treat a medical condition, and therefore is considered a medical device. FDA records showed that there was no marketing clearance for the product.

The FDA's Center for Devices and Radiological Health (CDRH) issued a Warning Letter on May 31, 2001, to Mr. Jean-Pierre Arnaudo, E-Med Innovations, Inc., Dallas, Texas. CDRH reviewed the firms advertising brochure on their Website for two products, the e-steth digital stethoscope and the CardioMailTM software. The e-steth digital stethoscope is a Class II medical device and requires premarket notification. FDA records did not show that the firm had obtained premarketing clearance for the e-steth digital stethoscope before offering it for sale. The CardioMailTM software was exempt from premarket notification. The Warning Letter advised the firm that marketing the digital stethoscope is a violation of the FD&C Act.