Regulatory Affairs Syndicator

Medical devices; immunology and microbiology devices; classification of reagents for detection of specific novel influenza A viruses. Final rule.

Fed Regist. 2006 Mar 22;71(55):14377-9

Authors:

The Food and Drug Administration (FDA) is classifying Reagents for detection of specific novel influenza A viruses into class II (special controls). Special controls that will apply to the device are the guidance document entitled, “Class II Special Controls Guidance Document: Reagents for Detection of Specific Novel Influenza A Viruses” and limitations of distribution of these reagents. The agency is taking this action in response to a petition submitted under the Federal Food, Drug, and Cosmetic Act (the act) as amended by the Medical Device Amendments of 1976, the Safe Medical Devices Act of 1990, the Food and Drug Administration Modernization Act of 1997, and the Medical Device User Fee and Modernization Act of 2002. The agency is classifying the device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device. Elsewhere in this issue of the Federal Register, FDA is publishing a notice of availability of a guidance document that is a special control for this device.

PMID: 16562353 [PubMed - in process]

Medical device recall authority–FDA. Final rule.

Fed Regist. 1996 Nov 20;61(225):59004-22

Authors:

The Food and Drug Administration (FDA) is establishing procedures for implementing the medical device recall authority provided in the Safe Medical Devices Act of 1990 (the SMDA). This statutory authority protects the public health by permitting FDA to remove dangerous devices from the market promptly. This authority complements other provisions of the device law, including tracking and notification.

PMID: 10163116 [PubMed - indexed for MEDLINE]

Human tissue intended for transplantation–FDA. Interim rule; opportunity for public comment.

Fed Regist. 1993 Dec 14;58(238):65514-21

Authors:

The Food and Drug Administration (FDA) is issuing an interim rule to require certain infectious disease testing, donor screening, and recordkeeping to help prevent the transmission of AIDS and hepatitis through human tissue used in transplantation. The regulations are effective upon publication. FDA is taking this action in response to growing concerns that some human tissue products are being offered for transplantation use without even the minimum donor testing and screening needed to protect recipients against human immunodeficiency virus (HIV) infection and hepatitis infection. The new regulations require all facilities engaged in procurement, processing, storage, or distribution of human tissues intended for transplant to ensure that minimum required infectious disease testing has been performed and that records documenting such testing for each tissue are available for inspection by FDA. The regulations also provide authority for the agency to conduct inspections of such facilities and to detain, recall, or destroy tissue for which appropriate documentation is not available.

PMID: 10131341 [PubMed - indexed for MEDLINE]

Medical devices; illustrative and designated lists for device tracking–FDA. Final rule and request for comments.

Fed Regist. 1993 Aug 16;58(156):43451-5

Authors:

The Food and Drug Administration (FDA) is amending the medical device tracking regulations to add the temporo-mandibular joint prostheses to the illustrative list of devices and the penile inflatable implant to the list of devices designated for tracking. These devices are being added to the illustrative and designated device lists based on the significance of the risk to health posed by their use. This action requires manufacturers to track these devices after distribution so that they can be located in the event of a recall or patient notification action. FDA requests comments on these changes. Elsewhere in this issue of the Federal Register, the agency is announcing notification of the change of status of the device tracking regulations and is suspending the effective date of the regulations until August 29, 1993.

PMID: 10171508 [PubMed - indexed for MEDLINE]

Delegations of authority and organization; Center for Devices and Radiological Health–FDA. Final rule.

Fed Regist. 1991 Oct 10;56(197):51169-70

Authors:

The Commissioner of Food and Drugs is redelegating authorities to certain officials of the Food and Drug Administration’s (FDA’s) Center for Devices and Radiological Health (CDRH) to temporarily suspend premarket approval applications and to recall devices in the event those devices would cause serious adverse consequences to health or death. These authorities were given to the FDA by the Safe Medical Devices Act of 1990.

PMID: 10115059 [PubMed - indexed for MEDLINE]

Medical devices; medical device reporting. Direct final rule.

Fed Regist. 2005 Feb 28;70(38):9516-28

Authors:

The Food and Drug Administration (FDA or we) is amending its regulation governing reporting of deaths, serious injuries, and certain malfunctions related to medical devices. We are revising the regulation into plain language to make the regulation easier to understand, and we are making technical corrections. Elsewhere in this issue of the Federal Register, we are publishing a companion proposed rule, under FDA’s usual procedures for notice and comment, to provide a procedural framework to finalize the rule in the event we receive any significant adverse comment and withdraw the direct final rule.

PMID: 15736310 [PubMed - indexed for MEDLINE]

Supplemental standards of ethical conduct and financial disclosure requirements for employees of the Department of Health and Human Services. Interim final rule with request for comments.

Fed Regist. 2005 Feb 3;70(22):5543-65

Authors:

The Department of Health and Human Services, with the concurrence of the Office of Government Ethics (OGE), is amending the HHS regulation that supplements the OGE Standards of Ethical Conduct. This interim final rule specifies additional procedural and substantive requirements that are necessary to address ethical issues at the National Institutes of Health (NIH) and updates nomenclature, definitions, and procedures applicable to other components of the Department. The rule: Revises the definition of a significantly regulated organization for the Food and Drug Administration (FDA); Updates the organization titles of designated separate agencies; Amends the gift exception for native artwork and craft items received from Indian tribes or Alaska Native organizations; Aligns the FDA prohibited holdings limit with the de minimis holdings exemption in OGE regulations; Revises prior approval procedures for outside activities; and, subject to certain exceptions: Prohibits NIH employees from engaging in certain outside activities with supported research institutions, health care providers or insurers, health-related trade or professional associations, and biotechnology, pharmaceutical, medical device, and other companies substantially affected by the programs, policies, or operations of the NIH; Bars NIH employees who file a public or confidential financial disclosure report from holding financial interests in substantially affected organizations; Subjects NIH non-filer employees to a monetary cap on holdings in such organizations; Specifies for NIH employees prior approval procedures for and limitations on the receipt of certain awards from outside sources; and Imposes a one-year disqualification period during which NIH employees are precluded from official actions involving an award donor. In addition, the Department is adding a new supplemental part to expand financial disclosure reporting requirements for certain outside activities and to ensure that prohibited financial interests are identified.

PMID: 15690579 [PubMed - indexed for MEDLINE]

Medical devices; general and plastic surgery devices; classification of the low energy ultrasound wound cleaner. Final rule.

Fed Regist. 2005 Nov 7;70(214):67353-5

Authors:

The Food and Drug Administration (FDA) is classifying the low energy ultrasound wound cleaner into class II (special controls). The special control that will apply to the device is the guidance document entitled "Class II Special Controls Guidance Document: Low Energy Ultrasound Wound Cleaner." The agency is taking this action in response to a petition submitted under the Federal Food, Drug, and Cosmetic Act (the act) as amended by the Medical Device Amendments of 1976, the Safe Medical Devices Act of 1990, and the Food and Drug Administration Modernization Act of 1997 (FDAMA). The agency is classifying this device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device. Elsewhere in this issue of the Federal Register, FDA is announcing the availability of the guidance document that will serve as the special control for the class II device.

PMID: 16273747 [PubMed - in process]