Tag Archive: medical devices

Dec 20 2019

New FDA guidance on alternate approaches in premarket notification for Class II medical devices

By Alice Li, MD, MSc, RAC (CAN), Regulatory Scientist, Cato Research FDA issued “The Abbreviated 510(k) Program – Guidance for Industry and Food and Drug Administration Staff” on 13 September 2019. The content of this guidance supersedes the content from 1998 guidance “The New 510(k) Paradigm – Alternate Approaches to Demonstrating Substantial Equivalence in Premarket …

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Aug 09 2018

Medical Devices: Clinical Trials in South Africa – Part 1

By Nicola Main, Clinical Research Manager I, Clinical Trial Operations – Rest of World Cato Research   Medical Device Workshop at MCC – 13/14 July 2017 – Summary for SACRA Members This workshop provided supporting information and explanation of items contained in the various guidelines regarding medical devices. These guidelines are in the process of being …

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Jan 27 2016

The FDA Wants To Hear Patients’ Voices

The FDA Wants To Hear Patients’ Voices by Joanne McNelis, Ph.D., Scientist at Cato Research In September the FDA announced the creation of its first-ever Patient Engagement Advisory Committee (PEAC) to advise the FDA commissioner on complex issues relating to medical devices, the regulation of devices, and their use by patients. This marks a major …

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Sep 19 2013

New FDA Guidances for August 2013

New guidances out last month include several device related guidances including a beloved (at least by me) Q&A guidance on GLPs in premarket device submissions; a listing of FY 2014 medical device small business user fees; and new information on risk-based monitoring, which is being pushed both by FDA and industry. Select Updates for Non-Clinical …

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Jul 18 2013

New FDA Guidances for June 2013

FDA was busy last month and released 14 Guidances to prove it, including the long awaited Guidance discussing the Breakthrough Therapy designation that was enacted by FDASIA.  Look for a review of “Expedited Programs for Serious Conditions––Drugs and Biologics” coming soon. New Guidances for June: Human Blood and Blood Components Intended for Transfusion or for …

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Jun 18 2013

New FDA Guidances for May 2013

FDA released 10 guidances in May, including two Q & A guidances, which I always find helpful (Charging for Investigational Drugs Under an IND and Expanded Access to Investigational Drugs for Treatment Use).  Additionally, as directed by FDASIA, a guidance was released discussing Priority Review of Premarket Submissions for Devices.  Among other information, this guidance …

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May 21 2013

New FDA Guidances for April 2013

There were many new Guidances out in April.  Notably, changes in postmarketing periodic safety reporting are discussed in this guidance.  See CATO’s take on some of the changes in postmarket reporting here. SUPAC: Manufacturing Equipment Addendum  Glass Syringes for Delivering Drug and Biological Products: Technical Information to Supplement International Organization for Standardization (ISO) Standard 11040-4 …

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Apr 11 2013

New FDA Guidances for March 2013

FDA released several interesting new guidances last month, including several regarding communications with the FDA. Types of Communication During the Review of Medical Device Submissions is in accordance with the MDUFA III goals and includes descriptions of acceptance review communications, substantive interactions, interactive review, and missed MDUFA decision communications. Formal Meetings Between the FDA and Biosimilar …

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Feb 04 2013

New FDA Guidances for January 2013

FDA has already released a handful of new guidances to start off the year 2013.  They include: Guidance for Industry and FDA Staff: Submissions for Postapproval Modifications to a Combination Product Approved Under a BLA, NDA, or PMA Humanitarian Use Device (HUD) Designations E3 Structure and Content of Clinical Study Reports – Questions and Answers …

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Jan 30 2013

Combination Products: What’s New?

A monoclonal antibody combined with a therapeutic drug. An EpiPen®. A drug packaged with its delivery device. All of these are examples of combination products. A combination product, according to the FDA, is “a product composed of any combination of a drug and a device; a biological product and a device; a drug and a …

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