News from the FDA

For more information on drug counterfeiting, see the article beginning on page 1.

Classification of the Breath Nitric Oxide Test System Breath nitric oxide test systems are being classified into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device.

For further information, go to http://a257.g.akamaitech.net/7/257/2422/14mar20010800/edocket.access.gpo.gov/2003/03-16953.htm.

Cordis Corp. Issues Letter Regarding the CYPHER Stent

Cordis Corp. has issued a letter to health care professionals to inform them of the rare but potential risk of thrombosis associated with the use of its product the CYPHER Sirolimus-Eluting Coronary Stent. This letter also provides clarification on the safe use of the product in accordance with the scientific evidence that led to product approval.

The CYPHER stent was approved in April 2003 for patients undergoing angioplasty procedures to open clogged coronary arteries. Since the product's introduction it is estimated that over 50,000 patients have received a CYPHER stent. To date, the FDA has received 47 Medical Device Reports (MDRs) of stent thrombosis occurring at the time of implantation or within a few days of implantation.

Reprocessed Single-Use Device Guidance Now Available

A guidance entitled “Guidance for Industry and FDA Staff; Medical Device User Fee and Modernization Act of 2002, Validation Data in Premarket Notification Submissions [510(k)s] for Reprocessed Single-Use Medical Devices” (validation data guidance) is now available. The Medical Device User Fee and Modernization Act of 2002 (MDUFMA) added a section to the act to establish new regulatory requirements for reprocessed single-use devices (SUDs). MDUFMA was signed into law on Oct. 26, 2002. One requirement of the new provision is the submission of validation data for certain class I and II reprocessed SUDs. This guidance document is intended to assist manufacturers of reprocessed SUDs in understanding and complying with this new MDUFMA requirement. The new section of MDUFMA establishes requirements applicable only to reprocessed SUDs.

For further information, see the article on reprocessed SUDs beginning on page 1. Also: http://a257.g.aka maitech.net/7/257/2422/14mar20010800/edocket.access.gpo.gov/2003/0317135.htm.

Admin Record Reopened on OTC External Analgesic Drugs

The FDA reopened the administrative record for the rulemaking for over-the-counter (OTC) external analgesic drug products to accept comments and data concerning OTC external analgesic drug products that have been filed with the Division of Dockets Management, FDA, since the administrative record officially closed. The FDA is also amending the tentative final monograph (proposed rule) to clarify the status of patch, plaster, and poultice dosage forms for OTC external analgesic drug products. The administrative record will remain open until Oct. 15 to allow for public comment. Submit written comments and data to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments to http://www.fda.gov/dockets/ecomments. For further information, contact: Gerald M. Rachanow, Center for Drug Evaluation and Research (HFD-560), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-2307.

Initiative to Heighten Battle Against Counterfeit Drugs

Commissioner of Food and Drugs Mark B. McClellan, M.D., Ph.D., announced a major new initiative to more aggressively protect American consumers from drugs that have been counterfeited (July 16). The new initiative includes creating an internal task force to explore the use of modern technologies and other measures such as stronger enforcement that will make it more difficult for counterfeit drugs to get distributed with, or deliberately substituted for, safe and effective drugs. The task force will submit its initial findings and recommendations in approximately 60 days and will issue a final report 5 months from now, after it has had the opportunity to hear from the public.

In the United States, drug counterfeiting is relatively rare, but the World Health Organization has estimated that perhaps 7% to 8% of drugs worldwide are counterfeit, and reports from some countries suggest that as much as one-half of those countries' drugs are counterfeit.

For more information on drug counterfeiting, see the article beginning on page 1.

Classification of the Breath Nitric Oxide Test System Breath nitric oxide test systems are being classified into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device.

For further information, go to http://a257.g.akamaitech.net/7/257/2422/14mar20010800/edocket.access.gpo.gov/2003/03-16953.htm.

Cordis Corp. Issues Letter Regarding the CYPHER Stent

Cordis Corp. has issued a letter to health care professionals to inform them of the rare but potential risk of thrombosis associated with the use of its product the CYPHER Sirolimus-Eluting Coronary Stent. This letter also provides clarification on the safe use of the product in accordance with the scientific evidence that led to product approval.

The CYPHER stent was approved in April 2003 for patients undergoing angioplasty procedures to open clogged coronary arteries. Since the product's introduction it is estimated that over 50,000 patients have received a CYPHER stent. To date, the FDA has received 47 Medical Device Reports (MDRs) of stent thrombosis occurring at the time of implantation or within a few days of implantation.

Reprocessed Single-Use Device Guidance Now Available

A guidance entitled “Guidance for Industry and FDA Staff; Medical Device User Fee and Modernization Act of 2002, Validation Data in Premarket Notification Submissions [510(k)s] for Reprocessed Single-Use Medical Devices” (validation data guidance) is now available. The Medical Device User Fee and Modernization Act of 2002 (MDUFMA) added a section to the act to establish new regulatory requirements for reprocessed single-use devices (SUDs). MDUFMA was signed into law on Oct. 26, 2002. One requirement of the new provision is the submission of validation data for certain class I and II reprocessed SUDs. This guidance document is intended to assist manufacturers of reprocessed SUDs in understanding and complying with this new MDUFMA requirement. The new section of MDUFMA establishes requirements applicable only to reprocessed SUDs.

For further information, see the article on reprocessed SUDs beginning on page 1. Also: http://a257.g.aka maitech.net/7/257/2422/14mar20010800/edocket.access.gpo.gov/2003/0317135.htm.

Admin Record Reopened on OTC External Analgesic Drugs

The FDA reopened the administrative record for the rulemaking for over-the-counter (OTC) external analgesic drug products to accept comments and data concerning OTC external analgesic drug products that have been filed with the Division of Dockets Management, FDA, since the administrative record officially closed. The FDA is also amending the tentative final monograph (proposed rule) to clarify the status of patch, plaster, and poultice dosage forms for OTC external analgesic drug products. The administrative record will remain open until Oct. 15 to allow for public comment. Submit written comments and data to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments to http://www.fda.gov/dockets/ecomments. For further information, contact: Gerald M. Rachanow, Center for Drug Evaluation and Research (HFD-560), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-2307.