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New CDRH Guidance in October

by Barbara Unger, GMP Quality Expert, and GMP Regulatory Intelligence Editor-in-Chief The FDA has been on a bit of a tear in publishing guidance for devices and generic drugs.  Here we address the CDRH guidance issued between September 29th and October 25th 2017 and provide summaries of their content.  Seven guidance listed below are final, and one is published for [...]

By |2017-11-09T16:29:42+00:00November 9th, 2017|510(k), FDA, FDA-Regulated Industry, FDAzilla, Medical Devices|

Differences Between Medical Device and Pharmaceutical Clinical Trials – A Primer

Given that the size of the pharmaceutical industry at times overshadows the medical device market, it is no surprise that companies that are just getting started in device development sometimes need clarification about the regulatory implications and practical differences between pharma clinical trials and medical device clinical trials. We’ve put together a basic primer to help guide readers through the [...]

FDA Doubles Medical Device User Fees

Is the pathway to quicker medical device regulatory approval or clearance to be found through the establishment of higher fees on the part of the Food and Drug Administration? It would seem so, given that the FDA has recently announced a new program that will double the amount of the user fees currently paid by the biggest players in the medical device [...]

Medical Devices and the EU Path

Over the past decade it has become common for some medical device companies to introduce a product to the European market prior to attempting to gain FDA approval and sell the same device in the United States. In some cases, depending on the classification and technology of the device, Europe can provide a quicker route to marketability. […]

A Closer Look At The FDA’s Human Factors Engineering Draft Guidance

In an effort to control overall risk in medical devices, the FDA has looked to Human Factors Engineering (HFE) as part of the design controls process to reduce or eliminate use-related hazards. Central to that process is the development of a risk analysis, which takes into account potential hazards that can occur through the use of a medical device. [...]

By |2016-07-12T16:04:42+00:00January 12th, 2012|510(k), cGMP Quality Assurance and FDA 483s, Medical Devices|

VCs Pressure FDA About Medical Device Approval Process

It’s a refrain that is becoming familiar in the medical device industry: over-regulation is strangling innovation.  Recently, however, this particular topic isn’t being championed by special interest groups representing medical device companies, but rather by a growing number of concerned outsiders from the venture capital industry who are becoming increasingly convinced that FDA regulations are beginning to choke back the [...]

New E&Y Report Offers Insight Into Med Device Approval Processes

The Ernst & Young “Pulse of the Industry: Medical Technology Report 2011” was released last month, bringing with it a host of data, recommendations, and insight applicable to medical device manufacturers of all sizes.  The report, which was presented at the Advamed 2011conference, aims to offer a global analysis of the entire medical device industry from a regulatory, economic, and demographic [...]

By |2016-07-12T16:09:10+00:00November 15th, 2011|510(k), cGMP Quality Assurance and FDA 483s, Medical Devices|

Is the FDA more predictable?

More than two years ago, FDA Matters suggested that one of FDA Commissioner Hamburg’s goals would be making it easier for stakeholders to anticipate agency actions. I was looking beyond transparency (see what FDA is doing and has done). I hoped the FDA would focus on the larger virtue of predictability (being able to anticipate FDA’s standards and actions). [...]

FDA Makes Changes To Informed Consent Requirements for Medical Device Trials

This past spring, medical device companies – and all other organizations participating in clinical trials – became subject to a new Final Rule regarding informed consent.  Specifically, the FDA implemented changes to existing informed consent regulations that now require the submission of clinical trial descriptions to the public ClinicalTrials.gov databank.  Trial participants must be informed of this fact by way [...]

By |2016-07-12T16:02:33+00:00October 18th, 2011|510(k), cGMP Quality Assurance and FDA 483s, Medical Devices|