FDA

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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17
Nov

Taking Medications Correctly Is Important

Food and Drug Administration Poor medication adherence can interfere with the ability to treat many diseases, leading to greater complications and a lower quality of life. [youtube_advanced url=”https://www.youtube.com/watch?v=Qh84l557-D0″ controls=”no” autoplay=”yes” rel=”no” modestbranding=”yes”] Are You Taking Medication as Prescribed? Medication adherence, or taking medications correctly, is generally defined as the extent to which patients take medication as prescribed by their doctors.

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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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10
Nov

FDA Sent Letters to Three Firms for Lack of Marketing Clearances

 The United States Food and Drug Administration Office of In Vitro Diagnostics and Radiological Health (OIR) | Center for Devices and Radiological Health (CDRH) November 3, 2015 The FDA/OIR/CDRH sent letters to three firms for lack of marketing clearances Letter to the DNA-Cardiocheck, Inc. It has come to our attention that you are currently marketing a direct-to-consumer test, the DNA-CardioCheck, which is intended to

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19
Oct

FDA Workshop Materials for PCLC Devices

FDA Public Workshop Materials Physiological Closed-Loop Controlled (PCLC) Devices October 13-14, 2015 The Food and Drug Administration (FDA) held a public Workshop entitled “Physiological Closed-Loop Controlled (PCLC) Devices.” The challenges related to the design, development, and evaluation of critical care PCLC devices were discussed. FDA considers PCLC devices an emerging technology and the workshop focused on design, development and performance

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16
Oct

FDA Small Business REdI Conference-November 2015

FDA Small Business Regulatory Education for Industry (REdI) Conference “Prescription Drug Labeling – Challenges and Issues”, November 3-4, 2015 This 2 day conference has been pre-approved by RAPS as eligible for up to 12 credits towards a participant’s RAC recertification upon full completion CDER Small Business and Industry Assistance (SBIA) invites you to attend our two-day November 3rd/4th Regulatory Education for

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9
Oct

Opdivo (nivolumab) Approved to Treat Patients with Advanced NSCLC

The U.S. Food and Drug Administration (FDA) Opdivo (nivolumab) Today FDA approved Opdivo (nivolumab) to treat patients with advanced (metastatic) non-small cell lung cancer whose disease progressed during or after platinum-based chemotherapy. Lung cancer is the leading cause of cancer death in the United States, with an estimated 221,200 new diagnoses and 158,040 deaths in 2015. The most common type

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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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