FDA/CDRH

13
Jan

FDA UDI Final Rule

Food and Drug Administration The Unique Device Identification (UDI) Final Rule On September 24, 2013, the FDA published a final rule establishing a unique device identification system (the UDI Rule).  The UDI Rule outlines labeling, data submission and standard date formatting requirements for all medical devices in commercial distribution in the U.S., unless an exception or alternative applies. The rule will be

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11
Dec

Regulatory History for Bionic Eye Retinal Prosthesis System

Argus II – Retinal Implant Bionic Eye – Retinal Prosthesis System World’s First Artificial Retina Feasibility Study Protocol: NCT00407602 First received: December 1, 2006 The objective of this feasibility study is to evaluate the safety and utility of the Argus II Retinal Stimulation System in providing visual function to blind subjects with severe to profound retinitis pigmentosa. Primary Outcome Measures

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9
Dec

FDA PMA and BLA for APLIGRAF and GINTUIT

Class III Medical Device and Biologics License Application (BLA) Class III Medical Device APLIGRAF: P950032 Expedited processing eras authorized on May 30 1995 based on the potential of Apligraf to provide a clinically important advance over existing alternatives in the treatment of chronic venous insufficiency ulcers. Intended Use/Indications Apligraf is indicated for use with standard therapeutic compression for the treatment of non infected partial and full

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9
Dec

Would Care Wound and Burn Dressing PMAs

Wound and Burn Dressing Summary of Regulatory Approval Pathways Class III Device PMA Combination Product Product Code:  MGR PMA Devices 1). Integra Dermal Regeneration Template: P900033 (a device to treat the skin of people with severe burns) INTEGRA® Dermal Regeneration Template is a device to treat the skin of people with severe burns. FDA has recently expanded the approved use of this

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13
Nov

FDA Orders a Firm to Recall All of Its Automated Endoscope Reprocessors

FDA Orders Recall The Order is Under Consent Decree for All Custom Ultrasonics Automated Endoscope Reprocessors (AERs) November 13, 2015 The U.S. Food and Drug Administration (FDA) ordered Custom Ultrasonics to recall all (an estimate of 2,800) of its automated endoscope reprocessors (AERs) currently in hospitals and outpatient clinics throughout the United States.  FDA’s order is due to the firm’s

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12
Nov

FDA CDRH MDUFA III Performance Report

The United States Food and Drug Administration (FDA) The Center for Devices and Radiological Health (CDRH) MDUFA III (FY 2013-2017) Performance Report for 4th Quarter of FY 2015 November 9, 2015 Table of Contents Section 1: PMA Originals and Panel Track Supplements DAGRID Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices DCD Division of Cardiovascular Devices DCTD Division

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22
Oct

FDA Final Order for Coronary Vascular Physiologic Simulation Software Device

FDA Final Order  Classification of the Coronary Vascular Physiologic Simulation Software Device The Food and Drug Administration (FDA) is classifying the coronary vascular physiologic simulation software device into class II (special controls). The special controls that will apply to the device are identified in this order and will be part of the codified language for the coronary vascular physiologic simulation software device’s classification. The Agency

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6
Oct

FDA Clears Carrier Screening Test for Bloom Syndrome

23andMe Personal Genome Service (PGS) Carrier Screening Test for Bloom Syndrome De Novo Regulatory Pathway:  DEN 140044 FDA Decision Device Description: Type of Test The 23andMe PGS Carrier Screening Test for Bloom Syndrome, using the Illumina Infinium BeadChip (23andMe BeadChip), is designed to be capable of detecting specific single nucleotide polymorphisms (SNPs) as well as other genetic variants. The 23andMe

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2
Oct

Determining the Risks of Medical Device Problems and the Actions

Determining the Risks of Medical Device Problems and  the Actions Health Hazard Evaluations (HHEs) and Health Risk Assessments (HRAs) What Does the FDA/CDRH Do?  FDA learns of problems with medical devices in different ways. Most often, a firm will notify its customers and FDA that it is issuing a recall. At other times, FDA’s analysis of medical device reports will

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26
Sep

Functional Electrical Stimulation Devices

External Functional Neuromuscular Stimulator Devices 21 CFR 882.5810 An external functional neuromuscular stimulator is an electrical stimulator that uses external electrodes for stimulating muscles in the leg and ankle of partially paralyzed patients (e.g., after stroke) to provide flexion of the foot and thus improve the patient’s gait. Classification. Class II (performance standards) Product Code: GZI (510k examples can be

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