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Information on Baby Products with SIDS Prevention Claims

October 17, 2011 8:31 am | by U.S. Food & Drug Administration | News | Comments

Some baby products are being marketed over-the-counter with claims to cure, treat, or prevent a disease or condition. Because of these claims, these baby products are medical devices, subject to FDA regulation.

CooperVision Avaira Toric Soft Contact Lenses: Class 1 Recall- Unintended Residue on Lenses

October 14, 2011 5:31 pm | by U.S. Food & Drug Administration | News | Comments

Presence of a silicone oil residue on lenses from certain lots of my cause range of symptoms such as hazy, blurry vision, discomfort to eye injuries requiring medical treatment.

MDUFMA III Proposal Delivery in Question as FDA Eyes Calendar

October 14, 2011 2:31 pm | by U.S. Food & Drug Administration | News | Comments

Industry resistance to an FDA move to fund training and hiring with user fee revenues has the agency concerned about missing a Jan. 15 deadline to give Congress proposals for the third reauthorization of the Medical Device User Fee and Modernization Act (MDUFMA).

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Device Panelists & #8217; Trial Critiques Are Killing Companies, Critics Say

October 14, 2011 2:30 pm | by U.S. Food & Drug Administration | News | Comments

Device innovation is suffering because FDA conflict of interest rules keep experienced and insightful practitioners from serving on advisory panels, industry and lawmakers say.

Class I Medical Device Recall: CooperVision AVAIRA Toric Soft Contact Lenses

October 14, 2011 12:30 pm | by U.S. Food & Drug Administration | News | Comments

Reason for Recall: The unintended presence of a silicone oil residue on lenses from certain lots of Avaira Toric contact lenses. Symptoms may range from hazy, blurry vision, discomfort to eye injuries requiring medical treatment.

Minutes From Negotiation Meeting on MDUFA III Reauthorization, August 31, 2011

October 13, 2011 7:30 am | by U.S. Food & Drug Administration | News | Comments

AdvaMed, MDMA, and MITA jointly offered preliminary feedback on the counter-proposal presented by the Agency on August 24 th. Industry stated that they appreciated the Agency?s effort to put forward proposals that addressed the issued important to...

FDA Safety Communication: Preventing Surgical Fires

October 13, 2011 7:30 am | by U.S. Food & Drug Administration | News | Comments

The FDA is advising health care professionals and health care facility executives and staff on factors that increase the risk of surgical fires, particularly the delivery of supplemental oxygen to patients...

Decorative Contact Lenses

October 12, 2011 5:30 am | by U.S. Food & Drug Administration | News | Comments

You may want to look like your favorite movie star or singer or have the perfect look for Halloween, but choosing to change the look of your eyes with contact lenses could cause a lot of damage to your eyesight.

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Sprycel (dasatinib): Drug Safety Communication - Risk of Pulmonary Arterial Hypertension

October 11, 2011 7:30 am | by U.S. Food & Drug Administration | News | Comments

Patients should be evaluated for signs and symptoms of underlying cardiopulmonary disease prior to starting Sprycel, as well as during treatment.

IOM & #8217;s 510(k) Proposal Keeps Getting Slammed

October 7, 2011 2:32 pm | by U.S. Food & Drug Administration | News | Comments

Device companies are maintaining a united front against an Institute of Medicine (IOM) recommendation that the FDA discard the 510(k). But some of what IOM has to say about other aspects of device oversight warrants consideration, commenters state.

MDUFMA Minutes: FDA Would Go With Total-Time Review Clock

October 7, 2011 2:31 pm | by U.S. Food & Drug Administration | News | Comments

The FDA has plans to revamp its clock and calendar for calculating how long device reviews take and would like to allocate user fee funds to internal training.

FDA-CMS Parallel Review

October 7, 2011 6:30 am | by U.S. Food & Drug Administration | News | Comments

The FDA and CMS have established a pilot program for concurrent review of certain FDA premarket review submissions for medical devices and CMS national coverage determinations.

Uprizing 2.0: Recall - Undeclared Drug Ingredient: Synthetic Steroid

October 6, 2011 12:30 pm | by U.S. Food & Drug Administration | News | Comments

Product marketed as testosterone booster contains superdrol, a synthetic steroid. Use of synthetic anabolic steroids may cause serious long-term adverse health consequences.

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Minutes From Negotiation Meeting on MDUFA III Reauthorization, August 24, 2011

October 6, 2011 6:30 am | by U.S. Food & Drug Administration | News | Comments

The Agency provided a response and counter-proposal to Industry's July 26, 2011 proposal that the Agency viewed as being responsive to Industry?s requests and objectives. The Agency indicated its goal of achieving several objectives that are held in...

Network of Experts- Expert Utilization Standard Operating Procedure (DRAFT)

October 4, 2011 8:31 am | by U.S. Food & Drug Administration | News | Comments

The purpose of the Network of Experts is to provide staff at the Center for Devices and Radiological Health (CDRH, Center) with rapid access to scientific, engineering, and medical expertise when it is needed to supplement existing knowledge and expertise

Network of Experts- Expert Enrollment Standard Operating Procedure (DRAFT)

October 4, 2011 8:30 am | by U.S. Food & Drug Administration | News | Comments

An SOP on the selection and enrolment of organizations for the Center for Devices and Radiological Health (CDRH) Network of Experts.

Information on Denture Adhesives

October 3, 2011 9:31 am | by U.S. Food & Drug Administration | News | Comments

Denture adhesives are pastes, powders or adhesive pads that may be placed in/on dentures to help them stay in place. Sometimes denture adhesives contain zinc to enhance adhesion...

Class I Medical Device Recall: Lee Medical International Inc., Custom Dialysis Trays / Kits

October 3, 2011 4:30 am | by U.S. Food & Drug Administration | News | Comments

Reason for Recall: These custom dialysis trays/kits contain alcohol swabs and prep pads that were recalled by H & P Industries. The alcohol swabs and prep pads may not be sterile. Patients receiving hemodialysis who use the swabs and pads may be at...

Devicemaker: EU Path a Band-Aid, No Cure for Frustrations With FDA

September 30, 2011 1:30 pm | by U.S. Food & Drug Administration | News | Comments

Taking a device to Europe to gain quicker market access is a short-term fix, not the solution to maintaining innovation.

Sebelius, Shuren: New Policies Not Enough, Fees Must Rise

September 30, 2011 1:30 pm | by U.S. Food & Drug Administration | News | Comments

CDRH Director Jeffrey Shuren and HHS Secretary Kathleen Sebelius agree that devicemakers have to pay more in user fees.

Draft Guidance for Industry and Food and Drug Administration Staff - De Novo Classification Process (Evaluation of Automatic Class III Designation)

September 30, 2011 6:30 am | by U.S. Food & Drug Administration | News | Comments

The purpose of this document is to provide guidance on the process for the submission and review of petitions under section 513(f)(2) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act), also known as the de novo classification process.

Documents the Center for Devices and Radiological Health is Considering for Development (FY12)

September 29, 2011 6:30 am | by U.S. Food & Drug Administration | News | Comments

This is the list of guidance documents CDRH is considering for development this year (2012). CDRH plans to update this list every year. CDRH invites interested persons to submit comments on any or all of the guidance documents on the list to docket...

PMA Final Decisions for July 2011

September 28, 2011 9:30 am | by U.S. Food & Drug Administration | News | Comments

These are Premarket Approvals (PMA), Product Development Protocols (PDP), Supplement and Notice Decisions for July 2011.

PMA Final Decisions for August 2011

September 28, 2011 9:30 am | by U.S. Food & Drug Administration | News | Comments

These are Premarket Approvals (PMA), Product Development Protocols (PDP), Supplement and Notice Decisions for August 2011.

FDA Shows Big-Company Bias in Inspections, Reviews: Devicemaker

September 23, 2011 2:31 pm | by U.S. Food & Drug Administration | News | Comments

SOUTH SAN FRANCISCO, Calif. – The FDA may be giving large companies preferential treatment when conducting inspections and reviewing device submissions, an executive with a smaller company alleged during a CDRH town hall meeting.

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