Category Archives: 510(k)

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 comment.  Many are associated with requirements in the Medical Device User Fee legislation, MDUFA.  Expect more of these moving forward into the MDUFA IV era.

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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 most important steps along the medical device regulatory pathway to market, and to explain the disparities between it and the clinical trial process for drug approval. Continue reading

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 industry. The new five-year medical device user fee deal, which is still awaiting Congressional approval, would seek $595 million from medical device manufacturers – a jump from the previous $287 million called for by the last five-year agreement. Another key component of the agreement is the requirement that the FDA meet with device companies through the process to address concerns and set goals for reducing review times. Continue reading

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. Continue reading

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. Continue reading

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 rate of technological progress in the United States. Continue reading

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 perspective. Continue reading

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). Continue reading

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 of modified informed consent forms. Continue reading