Medical Device News and Insights

Pre-Market Clearance Changes - 510(k) Update

Monday, June 28th, 2010 | FDA Medical Device Regulations, Industry News and Innovations | No Comments

At MDCI we have been keeping a close eye on the upcoming changes that could be made to the current 510(k) clearance process for licensing medical devices through the FDA.  As we have stated in the past, although these types of changes may at first seem daunting to companies which have an established licensing process in place, brand new medical device manufacturers can take heart that at least some of the new practices and requirements being introduced by the FDA should make certain aspects of 510(k) clearance less of a headache. › Continue reading

Tags: 510k submissions, FDA, FDA device approval, Institute of Medicine, medical device development

In Vitro Diagnostic Companies Called Out Regarding FDA Approval

Wednesday, June 23rd, 2010 | FDA Medical Device Regulations, Industry News and Innovations | No Comments

The regulatory environment surrounding in vitro diagnostics and personalized medicine got a little bit murkier this month with the revelation that the FDA contacted five manufacturers of genetic testing products to inform them that they were operating outside of the law.  Essentially, according to the FDA, the products being marketed by these companies qualified as medical devices, and as such required premarket review and approval prior to being legal for sale. › Continue reading

Tags: 510k submissions, FDA, FDA device approval, In vitro diagnostics

In Vitro Diagnostics - A Challenging Segment for Medical Device Companies

Tuesday, June 22nd, 2010 | FDA Medical Device Regulations, Medical Device Market | No Comments

In vitro diagnostic (IVD) companies are currently enjoying a favorable position in the industry.  The push to develop more specialized disease-detection tests, as well as systems capable of providing greater sensitivity during testing, is in many ways moving forward the in vitro diagnostic medical device segment.  This is despite the traditionally low amount of spending seen in this important area from agencies such as Medicare.  A desire for more accurate diagnostic devices is also one of the focuses of the current healthcare reform initiative, as it is seen as a cost-cutting tool that can facilitate more targeted and effective treatment as opposed to costly broad-spectrum or exploratory measures. › Continue reading

Tags: 510k submissions, CDRH, FDA, Medical Device Clinical Trials, OIVD

Trends, Services and Solutions for New Medical Device Companies - 510(k) Statistical Analysis

Friday, May 14th, 2010 | FDA Medical Device Regulations, Medical Device Clinical Trials | No Comments

At MDCI, we are in a position to notice trends emerging in the medical device landscape. Thanks to our involvement with many new companies seeking FDA approval or clearance of their medical devices, we are privy to struggles that organizations go through again and again as they move through this extensive and elaborate process. This article is the first in a series regarding the services that MDCI is most often called upon to provide fledgling medical device start-ups as they navigate towards bringing a new device or diagnostic successfully to market. › Continue reading

Tags: 510k submissions, FDA, FDA device approval, Medical Device Clinical Trials, medical device development

New CDRH Transparency Site - A Good 510(k) Submission Resource

Sunday, May 2nd, 2010 | Industry News and Innovations | No Comments

When bringing a new medical device to market, you can never get too many different perspectives on exactly what the process might entail. At MDCI, we enjoy helping our clients to understand the ins and outs of a 510(k) submission and we welcome information sources that could be helpful in their quest to successfully market a new medical device. › Continue reading

Tags: 510k submissions, CDRH, FDA, medical device development

Expect Greater FDA Enforcement of 510(k) Summary Content

Monday, January 25th, 2010 | FDA Medical Device Regulations | No Comments

It may be time for sponsors of 510(k) premarket notifications to revisit the fundamentals.

MDCI has learned that CDRH review staff have been directed to pay closer attention to 510(k) Summary content and that FDA is now including a reminder about 510(k) content in its standard Agency letters verifying receipt of 510(k) premarket notifications.

While there has been no formal announcement of this closer scrutiny, our review of the relevant Device Advice page revealed that information about 510(k) summaries was updated on January 8, 2010 and now directly reflects the information specified in 21 CFR 807.92.  The updated Device Advice content is available here. › Continue reading

Tags: 21 CFR 807.92, 510k submissions, 510k summary, CDRH, FDA Device Advice, FDA enforcement

Pre-IDE Submission Advice for 510(k) Sponsors

Wednesday, August 5th, 2009 | FDA Medical Device Regulations | No Comments

MDCI read with interest the August 3 article in the Gray Sheet, “510(k) Sponsors Should Be Wary Of Informal Talk with FDA“. Our experiences with the consequences of basing critical regulatory strategy decisions on informal communications with FDA are similar to those presented in the article by John Smith of Hogan & Hartson.

In fact, MDCI has observed that FDA review staff are increasingly reluctant to provide informal feedback on substantive issues. More and more often, a reviewer will recommend that a pre-IDE be filed with sufficient background information and specific questions to be addressed in order to ensure that FDA’s feedback is accurate and appropriate.

While these pre-IDE submissions can be intensive, the work product can often be recycled, in part or in total, for a subsequent filing (IDE or 510(k), for instance). The time spent laying the groundwork prior to filing a premarket submission via the pre-IDE process is almost always justified by a streamlined review process for the premarket submission.

Manufacturers do need to be careful when considering whether or not a pre-IDE is the appropriate mechanism for resolving the issue at hand. A novel technology or test strategy can only be fully vetted during the review of a premarket submission. For instance, while FDA may agree that a test conducted in accordance with a specified protocol is plausible to support an element of safety and/or effectiveness for a particular device during the pre-IDE process, the review staff may ultimately decide following review of the 510(k) premarket notification that a substantial equivalence determination cannot be made based on the information provided. FDA’s recommendations made during the pre-IDE process are not binding and the manufacturer must carefully manage their expectations, and that of their organization, when implementing a regulatory strategy developed using FDA feedback obtained during the pre-IDE process.

MDCI fully supports the FDA in its efforts to further develop the pre-IDE process and often recommends this approach when FDA guidance is necessary prior to submitting a premarket application.

Tags: 510k submissions, FDA, Pre-IDE