News from the FDA

FDA Releases Modifications to List of Recognized Standards

The FDA announced a publication containing modifications the agency is making to the list of standards FDA recognizes for use in pre-market reviews (FDA Recognized Consensus Standards). The publication, titled “Modifications to the List of Recognized Standards, Recognition List Number: 008″ (Recognition List Number: 008) will assist manufacturers who elect to declare conformity with consensus standards to meet certain requirements for medical devices.

For single copies on a 3.5-in. diskette, send a written request to the Division of Small Manufacturers Assistance (DSMA), Center for Devices and Radiological Health (CDRH) (HFZ-220), Food and Drug Administration, 1350 Piccard Dr., Rockville, MD 20850. Send two self-addressed adhesive labels to assist that office in processing your requests, or fax your request to 301-443-8818. For further information, go to http://a257.g.akamaitech.net/7/257/2422/14mar20010800/edocket.access.gpo.gov/2003/03-10417.htm.

Blood Product Safety and SARS

The FDA has recently made available a new document titled “Guidance for Industry: Recommendations for the Assessment of Donor Suitability and Blood Product Safety in Cases of Suspected Severe Acute Respiratory Syndrome (SARS) or Exposure to SARS,” dated April 2003. The guidance document provides the FDA's recommendations for assessing donor suitability and blood product safety with respect to SARS. The guidance applies to whole blood and blood components intended for transfusion and to blood components including recovered plasma, source leukocytes, and source plasma intended for use in further manufacturing into injectable or non-injectable products.

The agency is soliciting public comment, but is implementing this guidance immediately because the agency has determined that prior public participation is not appropriate since SARS may pose immediate safety risks to the blood supply. Those interested may submit written or electronic comments regarding this guidance document to the Dockets Management Branch.

Submit written requests for single copies of this guidance to the Office of Communication, Training, and Manufacturers Assistance (HFM-40), Center for Biologics Evaluation and Research (CBER), Food and Drug Administration, 1401 Rockville Pike, Rockville, MD 20852-1448. Send one self-addressed adhesive label to assist the office in processing your requests. The guidance document may also be obtained by mail by calling the CBER Voice Information System at 1-800-835-4709 or 301-827-1800. It may also be obtained over the Internet at either http://www.fda.gov/cber/guidelines.htm or http://www.fda.gov/ohrms/dockets/default.htm .

Submit written comments on the guidance to the Dockets Management Branch (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, go to http://a257.g.akamaitech.net/7/257/2422/.

Accreditation Criteria: Inspection by Accredited Persons Program

The FDA has announced the criteria it will use to accredit persons for the purpose of conducting inspections of eligible device manufacturers under section 201 of the Medical Device User Fee and Modernization Act of 2002 (MDUFMA), which established an “inspection by accredited persons” program. These criteria can be found at http://a257.g.akamaitech.net/7/257/2422/14mar20010800/edocket.access.gpo.gov/2003/03-10415.htm, and will become effective immediately after approval by the Office of Management and Budget (OMB). Following OMB approval, the FDA will begin accepting applications for the program.

Those interested in participating in the program can obtain a guidance document titled “Implementation of the Inspection by Accredited Persons Program under the Medical Device User Fee and Modernization Act of 2002; Accreditation Criteria: Guidance for Industry, FDA Staff and Third Parties” by sending written requests for single copies on a 3.5-in. diskette to: Division of Small Manufacturers, International, and Consumer Assistance (HFZ-220), Center for Devices and Radiological Health (CDRH), Food and Drug Administration, 1350 Piccard Drive, Rockville, MD 20850. Send two self-addressed adhesive labels to assist that office in processing your request, or fax your request to 301-443-8818.

Termination of Exemptions

The FDA has published, effective April 30, a list (List I) of critical reprocessed single-use devices (SUDs) whose exemption from premarket submission is being terminated and for which validation data, as specified under the Medical Device User Fee and Modernization Act of 2002 (MDUFMA), is necessary in a premarket notification (510(k)); and a list (List II) of reprocessed SUDs that are currently subject to 510(k) requirements for which the FDA has determined that validation data, as specified under MDUFMA, is necessary in a 510(k). The FDA is requiring submission of these data to ensure that these reprocessed SUDs are substantially equivalent to predicate devices in accordance with MDUFMA.

Manufacturers of SUDs identified in List I whose exemption is being terminated must submit 510(k)s for these devices by July 30, 2004, or their devices may no longer be marketed. Manufacturers who already have clearance letters for SUDs identified in List II must submit validation data for these devices by January 30, 2004, or marketing of these devices must cease.

For further details, go to http://a257.g.akamaitech.net/7/257/2422/14mar20010800/edocket.access.gpo.gov/2003/03-10413.htm.

Meeting of Cardiovascular and Renal Drugs Advisory Committee

The Cardiovascular and Renal Drugs Advisory Committee, a public advisory committee of the FDA, plans to meet at the end of May to provide advice and recommendations to the agency on FDA's regulatory issues.

The meeting will be held on May 29, from 8 a.m. to 5 p.m. and on May 30, from 8 a.m. to 12 Noon at the Holiday Inn, Kennedy Ballroom, 8777 Georgia Ave., Silver Spring, MD. The contact person is Jayne E. Peterson, Center for Drug Evaluation and Research (HFD-21), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-7001, [email protected], or FDA Advisory Committee Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC area), code 12533. When available, background materials for this meeting will be posted 1 business day prior to the meeting on the FDA Web site at: www.fda.gov/ohrms/dockets/ac/acmenu.htm. (Click on the year 2003 and scroll down to Cardiovascular and Renal Drugs Advisory Committee meetings.)

For further information, go to http://a257.g.akamaitech.net/7/257/2422/14mar20010800/edocket.access.gpo.gov/2003/03-10805.htm.

Final Revision to Reye's Syndrome Warning Labels

The FDA is issuing a final rule to amend its regulations to revise the Reye's syndrome warning required for oral and rectal over-the-counter (OTC) human drug products containing aspirin, and to require a warning on OTC drug products containing non-aspirin salicylates as active ingredients. The revised warning will inform consumers of the symptoms of Reye's syndrome and advise that aspirin and non-aspirin salicylate drug products should not be given to children or teenagers who have or are recovering from chicken pox or flu-like symptoms. This final rule also finalizes FDA's notice of proposed rulemaking to require a Reye's syndrome warning for orally administered OTC drug products for relief of symptoms associated with overindulgence in food and drink (overindulgence drug products) that contain bismuth subsalicylate that was published in the Federal Register of May 5, 1993 (58 FR 26886). This final rule is effective April 19, 2004.

The compliance dates for drugs used to treat specific maladies can be found at http://a257.g.akamaitech.net/7/257/2422/14mar20010800/edocket.access.gpo.gov/2003/03-9382.htm.

FDA Releases Modifications to List of Recognized Standards

The FDA announced a publication containing modifications the agency is making to the list of standards FDA recognizes for use in pre-market reviews (FDA Recognized Consensus Standards). The publication, titled “Modifications to the List of Recognized Standards, Recognition List Number: 008″ (Recognition List Number: 008) will assist manufacturers who elect to declare conformity with consensus standards to meet certain requirements for medical devices.

For single copies on a 3.5-in. diskette, send a written request to the Division of Small Manufacturers Assistance (DSMA), Center for Devices and Radiological Health (CDRH) (HFZ-220), Food and Drug Administration, 1350 Piccard Dr., Rockville, MD 20850. Send two self-addressed adhesive labels to assist that office in processing your requests, or fax your request to 301-443-8818. For further information, go to http://a257.g.akamaitech.net/7/257/2422/14mar20010800/edocket.access.gpo.gov/2003/03-10417.htm.

Blood Product Safety and SARS

The FDA has recently made available a new document titled “Guidance for Industry: Recommendations for the Assessment of Donor Suitability and Blood Product Safety in Cases of Suspected Severe Acute Respiratory Syndrome (SARS) or Exposure to SARS,” dated April 2003. The guidance document provides the FDA's recommendations for assessing donor suitability and blood product safety with respect to SARS. The guidance applies to whole blood and blood components intended for transfusion and to blood components including recovered plasma, source leukocytes, and source plasma intended for use in further manufacturing into injectable or non-injectable products.

The agency is soliciting public comment, but is implementing this guidance immediately because the agency has determined that prior public participation is not appropriate since SARS may pose immediate safety risks to the blood supply. Those interested may submit written or electronic comments regarding this guidance document to the Dockets Management Branch.

Submit written requests for single copies of this guidance to the Office of Communication, Training, and Manufacturers Assistance (HFM-40), Center for Biologics Evaluation and Research (CBER), Food and Drug Administration, 1401 Rockville Pike, Rockville, MD 20852-1448. Send one self-addressed adhesive label to assist the office in processing your requests. The guidance document may also be obtained by mail by calling the CBER Voice Information System at 1-800-835-4709 or 301-827-1800. It may also be obtained over the Internet at either http://www.fda.gov/cber/guidelines.htm or http://www.fda.gov/ohrms/dockets/default.htm .

Submit written comments on the guidance to the Dockets Management Branch (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, go to http://a257.g.akamaitech.net/7/257/2422/.

Accreditation Criteria: Inspection by Accredited Persons Program

The FDA has announced the criteria it will use to accredit persons for the purpose of conducting inspections of eligible device manufacturers under section 201 of the Medical Device User Fee and Modernization Act of 2002 (MDUFMA), which established an “inspection by accredited persons” program. These criteria can be found at http://a257.g.akamaitech.net/7/257/2422/14mar20010800/edocket.access.gpo.gov/2003/03-10415.htm, and will become effective immediately after approval by the Office of Management and Budget (OMB). Following OMB approval, the FDA will begin accepting applications for the program.

Those interested in participating in the program can obtain a guidance document titled “Implementation of the Inspection by Accredited Persons Program under the Medical Device User Fee and Modernization Act of 2002; Accreditation Criteria: Guidance for Industry, FDA Staff and Third Parties” by sending written requests for single copies on a 3.5-in. diskette to: Division of Small Manufacturers, International, and Consumer Assistance (HFZ-220), Center for Devices and Radiological Health (CDRH), Food and Drug Administration, 1350 Piccard Drive, Rockville, MD 20850. Send two self-addressed adhesive labels to assist that office in processing your request, or fax your request to 301-443-8818.

Termination of Exemptions

The FDA has published, effective April 30, a list (List I) of critical reprocessed single-use devices (SUDs) whose exemption from premarket submission is being terminated and for which validation data, as specified under the Medical Device User Fee and Modernization Act of 2002 (MDUFMA), is necessary in a premarket notification (510(k)); and a list (List II) of reprocessed SUDs that are currently subject to 510(k) requirements for which the FDA has determined that validation data, as specified under MDUFMA, is necessary in a 510(k). The FDA is requiring submission of these data to ensure that these reprocessed SUDs are substantially equivalent to predicate devices in accordance with MDUFMA.

Manufacturers of SUDs identified in List I whose exemption is being terminated must submit 510(k)s for these devices by July 30, 2004, or their devices may no longer be marketed. Manufacturers who already have clearance letters for SUDs identified in List II must submit validation data for these devices by January 30, 2004, or marketing of these devices must cease.

For further details, go to http://a257.g.akamaitech.net/7/257/2422/14mar20010800/edocket.access.gpo.gov/2003/03-10413.htm.

Meeting of Cardiovascular and Renal Drugs Advisory Committee

The Cardiovascular and Renal Drugs Advisory Committee, a public advisory committee of the FDA, plans to meet at the end of May to provide advice and recommendations to the agency on FDA's regulatory issues.

The meeting will be held on May 29, from 8 a.m. to 5 p.m. and on May 30, from 8 a.m. to 12 Noon at the Holiday Inn, Kennedy Ballroom, 8777 Georgia Ave., Silver Spring, MD. The contact person is Jayne E. Peterson, Center for Drug Evaluation and Research (HFD-21), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-7001, [email protected], or FDA Advisory Committee Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC area), code 12533. When available, background materials for this meeting will be posted 1 business day prior to the meeting on the FDA Web site at: www.fda.gov/ohrms/dockets/ac/acmenu.htm. (Click on the year 2003 and scroll down to Cardiovascular and Renal Drugs Advisory Committee meetings.)

For further information, go to http://a257.g.akamaitech.net/7/257/2422/14mar20010800/edocket.access.gpo.gov/2003/03-10805.htm.