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FDA Monitors Feedback on 510(k) Guidance Revisions

FDA Monitors Feedback on 510(k) Guidance Revisions

The FDA is sticking with the foundation of its 1997 Guidance on 501(k) device modifications, with plans that follow device industry feedback, according to an article in The Gray Sheet.  In a report submitted to Congress, the 1997 guidance is a “solid foundation and should remain mostly unchanged.”

PMA & 510(k): Disagreements Regarding Device Reviews

Disagreements Regarding Device Reviews

The Department of Health and Human Services (HHS) is the United States government’s principal agency for protecting the health of all Americans and providing essential human services, especially for those who are least able to help themselves, according to the government website.

AdvaMed: Don’t Change 510(k) Rules

Don’t Change 510(k) Rules

AdvaMed is pushing back on an initiative in Congress to have the FDA to tighten policies for approving modifications of on-the-market medical devices.  In an article in FierceMedicalDevices, AdvaMed contends there is nothing wrong with the current 510(k) program.  AdvaMed contends the system has worked well for 16 years, so no changes are needed.

510(k) Device Modifications - FDA Summer Workshop

510(k) Device Modifications

On April 30, 2013, FDA announced a workshop titled “510(k) Device Modifications: Deciding When to Submit a 510(k) for a Change to an Existing Device” scheduled for June 13, 2013. The main purpose of the meeting is to discuss the agency’s past, present, and future policy on 510(k) modifications. The FDA is inviting external stakeholders to provide discussion and bring examples of actual device modifications to use in developing future policy.

Will Third Party Reviewers Result in Faster Review Times?

Will Third Party Reviewers Result in Faster Review Times

Third Party Recognition Boards (TPRs) provide manufacturers of eligible devices a voluntary alternative review process that may yield more rapid 510(k) decisions.  Recently FDA issued draft guidance, “Accreditation and Reaccreditation Process for Firms under the Third Party Review Program.” TPRs are intended to enable FDA to use its resources for reviewing higher-risk and complex devices and also hopefully increase the review times for the medical device industry.

Should Certain Devices be Held to a Higher Standard?

Should Certain Devices be Held to a Higher Standard?

Many researchers are proposing a reclassification of all hip joint metal-on-metal hips as there may exist a regulatory loop-hole allowing dangerous devices to reach patients. FDA proposed a new rule that would require these devices to submit a Premarket Approval Application (PMA) which were being accepted through the 510(k) process.

How Would You Improve FDA’s Device Review Process?

How Would You Improve FDA’s Device Review Process?

This is a question that FDA is asking the public. Recently on Federal Register, the FDA announced an opportunity for the public to comment as part of an assessment process of the medical device review/submissions.  This opportunity stems from the MDUFA Commitment Letter, where FDA has a section describing the assessment of review process management to meet certain performance goals agreed to by industry and FDA.

Improvements in Device Review- Are Things Finally Turning Around?

Imrprovements in Device Review

For quite some time we’ve watched the blame for slow review times pass between industry and FDA. One side claims the pathway to approval lacks transparency and predictability, the other claims the submissions are of poor quality. But could this coming year be the start of a new relationship between FDA and industry? According to a new report on FDA’s website, the plan implemented in January 2011 aimed to modernize and improve the premarket review of medical devices is working. This development seems promising as the speed and predictability of medical device review has improved for the first time in almost a decade- according to FDA’s report.

FDA Audit Results- 510(k) NSE Determination

FDA Audit Results

In order to better understand the CDRH’s review of submissions that were found to be Not Substantially Equivalent (NSE), FDA published on its website the initial results of 510(k) audit as part of the Action Plan implemented in January 2011. The determination of NSE not only is an inefficient use of FDA’s time and resources, but can also be a costly delay for industry. With this information and analysis now available, the goal is for sponsors to understand the reasons the NSE determination resulted, as well add some clarification to the process.

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FDA’s 510(k) - A BIG Thumbs Down?

FDA's 510(k) - a Big Thumbs Down

A recent survey of almost 200 med-tech executives measured the perceptions of the 510(k) pathway, FDA’s performance, and FDA’s consistency. While FDA continues to try and clarify the pathway for approval, there continues to be much controversy and confusion of the direction of the program. This is in stark contrast to FDA’s goal of 510(k) which is to provide predictability for companies seeking lower-risk device approval. So, what did the recent survey show?

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