Latest Federal Register Notices
DEVICES
Surgical Tools for Urogynecologic Mesh Reclassified
Federal Register Final Order: FDA has reclassified surgical instrumentation for use with urogynecologic surgical mesh from Class 1 (general controls) exempt from premarket notification to Class 2 (special controls) subject to premarket notification, and identifying them as ‘‘specialized surgical instrumentation for use with urogynecologic surgical mesh.’’ FDA is designating special controls that are necessary to provide a reasonable assurance of safety and effectiveness of the device. To view the order, click here.
Tech Electronic Radiation Standards Committee Renewed
Federal Register notice: FDA has renewed its Technical Electronic Product Radiation Safety Standards Committee for an additional two years beyond the charter expiration date. The new charter will be in effect until 12/24/2018. To view the notice, click here.
FDA Draft Guide on Bone Anchor Submissions
Federal Register Notice: FDA has made available a draft guidance on “Premarket Notification (510(k)) Submissions for Bone Anchors.” The document provides recommendations for the information and testing that should be included in premarket submissions for bone anchor(suture anchor) devices used in the appendicular skeleton for attachment of soft tissue to bone. To view the notice, click here.
DRUGS
Research Planned on Deceptive Drug Promotion
Federal Register Notice: FDA is seeking comments on a new information collection, “Consumer and Healthcare Professional Identification of and Responses to Deceptive Prescription Drug Promotion.” The proposed research is intended to determine how well consumers and healthcare professionals can identify and respond to deceptive prescription drug promotion. “The ability to identify such promotion has important public health implications,” the notice says. “If unable to identify deceptive promotion, consumers may ask their healthcare professionals to prescribe specific drugs they would not otherwise request. Likewise, healthcare professionals unable to identify deceptive promotion may prescribe specific drugs that they would not otherwise prescribe.” To view the notice, click here.
Guidance on Electronic Reporting for Compounders
Federal Register Notice: FDA has made available a guidance entitled “Electronic Drug Product Reporting for Human Drug Compounding Outsourcing Facilities Under Section 503B of the Federal Food, Drug, and Cosmetic Act.” The document addresses new provisions added by the Drug Quality and Security Act and updates reporting instructions for drug compounders that choose to register as outsourcing facilities. Such compounders must report information on the drugs they compounded in structured product labeling format using FDA’s electronic submissions system unless it grants a request for a waiver. To view the notice, click here.
GENERAL
Workshop Planned on Tick-borne Diseases
Federal Register Notice: FDA has announced a 4/6 public workshop entitled “Emerging Tick-Borne Diseases and Blood Safety” that will discuss tick-borne pathogens that continue to emerge as threats to blood safety. It will also review the effectiveness of current and potential mitigation strategies, and the general approach to decision making on blood safety interventions. To view the notice, click here.