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CDRH Aiming to Toughen Stance On Use of Old Predicate Devices

October 30, 2010 1:31 pm | by U.S. Food & Drug Administration | News | Comments

Amid calls from devicemakers to improve its policies on predicate devices and promises from CDRH to do so, the center is beginning to clarify changes that may be in the works as part of its 510(k) overhaul.

Sen. Grassley Hunting for Link Between Medtronic, VA Adviser

October 30, 2010 1:31 pm | by U.S. Food & Drug Administration | News | Comments

In another inquiry into devicemaker ties, Sen. Chuck Grassley (R-Iowa) is questioning the exact nature of the relationship between Medtronic and a former consultant, Stephen Ondra, who now serves as a senior policy adviser at the Department of Veterans Affairs (VA).

Heparin Sodium (B. Braun): Recall - Trace Contaminant

October 29, 2010 1:31 pm | by U.S. Food & Drug Administration | News | Comments

Oversulfated chondroitin sulfate (OSCS) contaminant found during sample testing.

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Federal Register: Mammography Quality Standards Act Requirements, 66104 [2010?27159]

October 27, 2010 5:31 am | by U.S. Food & Drug Administration | News | Comments

Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; The Mammography Quality Standards Act Requirements

Federal Register: Draft Guidance, Emergency Use Authorization of Medical Products, 66104 [2010?27160]

October 27, 2010 5:30 am | by U.S. Food & Drug Administration | News | Comments

Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Draft Guidance, Emergency Use Authorization of Medical Products

Federal Register: Risk Communication Advisory Committee; Amendment of Notice

October 26, 2010 5:30 am | by U.S. Food & Drug Administration | News | Comments

On November 8 and 9, 2010, the Committee will hear and discuss developments in FDA's ongoing communications programs, such as the challenges of effectively communicating with patients and caregivers about appropriate use of medical devices when...

GnRH Agonists: Label Change - Increased Risk of Diabetes and Cardiovascular Disease (Update)(2)

October 20, 2010 1:31 pm | by U.S. Food & Drug Administration | News | Comments

New information warns about increased risk of diabetes and certain cardiovascular diseases (heart attack, sudden cardiac death, stroke) in men receiving these medications for the treatment of prostate cancer.

PMA Final Decisions for September 2010(2)

October 19, 2010 12:31 pm | by U.S. Food & Drug Administration | News | Comments

These are Premarket Approvals (PMA), Product Development Protocols (PDP), Supplement and Notice Decisions for September 2010.

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Federal Register: Medical Device User Fees; Public Meeting; Extension of Comment Period

October 18, 2010 5:30 am | by U.S. Food & Drug Administration | News | Comments

The FDA is extending to November 1, 2010, the comment period for the notice that appeared in the Federal Register of August 13, 2010 (75 FR 49502).

Federal Register: Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Testing Communications on Medical Devices a...

October 18, 2010 5:30 am | by U.S. Food & Drug Administration | News | Comments

The FDA is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.

Excelsior Medical 5 ml Fill in 6 cc Prefilled Saline Flush Syringes: Recall - Potential Loss of Sterility

October 15, 2010 12:31 pm | by U.S. Food & Drug Administration | News | Comments

Exposure to syringes with a sterility issue could result in systemic infection, which may lead to serious injury and/or death.

CareFusion Corporation Alaris PC Units (Model 8015): Recall - Potential for Delay or Interruption of Therapy

October 15, 2010 11:30 am | by U.S. Food & Drug Administration | News | Comments

Hardware communication error may lead to serious injury or death.

CDRH FOIA Electronic Reading Room (Added ReGen Biologics, Inc. Letter and Review Memo)

October 15, 2010 8:31 am | by U.S. Food & Drug Administration | News | Comments

Freedom of Information Act documents, in Adobe PDF format.

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Class I Medical Device Recall: CareFusion Corporation, Alaris PC Units (Model 8015)

October 15, 2010 8:30 am | by U.S. Food & Drug Administration | News | Comments

Reason for Recall: Under certain wireless network conditions, a communication error can occur, which freezes the PC Unit screen. This error may result in a delay of therapy and inability to make programming changes to current infusions...

Chelation Products: Unapproved Over-the-Counter Drugs - Consumer Warning

October 14, 2010 10:30 am | by U.S. Food & Drug Administration | News | Comments

Consumers advised to avoid OTC chelation products because of the potential for serious harm associated with their use, including dehydration, kidney failure, and death.

Bisphosphonates (Osteoporosis Drugs): Label Change - Atypical Fractures Update

October 13, 2010 9:30 am | by U.S. Food & Drug Administration | News | Comments

Risk of atypical fractures of the thigh, known as subtrochanteric and diaphyseal femur fractures, in patients who take bisphosphonates for osteoporosis.

Federal Register: Innovations in Technology for the Treatment of Diabetes: Clinical Development of the Artificial Pancreas (an Autonomous System); Public Workshop

October 13, 2010 6:30 am | by U.S. Food & Drug Administration | News | Comments

The topics to be discussed are the current state of device systems for autonomous systems for the treatment of diabetes mellitus, the challenges in developing this expert system using existing technology, a discussion of the clinical expectations and...

Lipitor (atorvastatin) 40 mg: Recall specific bottles

October 10, 2010 12:30 pm | by U.S. Food & Drug Administration | News | Comments

Specific bottles of Lipitor 40 mg recalled due to a small number of reports of an uncharacteristic odor.

Guidance for Industry and FDA Staff - Addition of URLs to Electronic Product Labeling

October 6, 2010 10:30 am | by U.S. Food & Drug Administration | News | Comments

FDA is issuing this guidance document to recommend that manufacturers include their Uniform Resource Locator (URL) on their electronic product labels in addition to the requirements under 21 CFR 1010.3(a)(1) and (2) that manufacturers include their full..

Grassley: More Government Oversight Needed to Prove the Value of GPOs

October 1, 2010 2:30 pm | by U.S. Food & Drug Administration | News | Comments

Sen. Chuck Grassley (R-Iowa) is pressuring Congress to increase government oversight of group purchasing organizations (GPOs), which, through their purchasing contracts, control devicemaker access to their member hospitals.

OIG Is Taking a Second Look at Claims of Management Interference at CDRH

October 1, 2010 2:30 pm | by U.S. Food & Drug Administration | News | Comments

Old claims of coercion at CDRH are being tackled once again — at CDRH itself and in two reviews at HHS’ Office of Inspector General (OIG).

Consumer Information on: Abbott RealTime HBV Assay - P080026

October 1, 2010 7:31 am | by U.S. Food & Drug Administration | News | Comments

Abbott RealTime HBV is a laboratory test kit that measures the amount of hepatitis B viral DNA in the blood of an individual infected by the hepatitis B virus (HBV). Viral DNA is the genetic material from the hepatitis B virus.

Summary Information for: Abbott RealTime HBV Assay(2)

October 1, 2010 7:31 am | by U.S. Food & Drug Administration | News | Comments

Labeling, Approval Order, and Summary of Safety and Effectiveness for Abbott RealTime HBV Assay (P080026).

Search the CDRH Inspections Database

September 30, 2010 12:32 pm | by U.S. Food & Drug Administration | News | Comments

Search the CDRH Inspections Database by various fields, such as company name, location, medical specialty, etc.

About the CDRH Inspections Database(2)

September 30, 2010 12:31 pm | by U.S. Food & Drug Administration | News | Comments

The CDRH Inspections Database1 provides information about medical device inspections that were the responsibility of CDRH from 2008 to the present.

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