Compliance In Focus

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 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.

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.

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  Recently FDA issued draft guidance, “Accreditation and Reaccreditation Process for Firms under the Third Party Review Program.”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.

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.

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.

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.

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.

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?

There continues to be much discussion over the FDA’s 510(k) program, which has led to controversy and confusion over the direction of the program.  In fact, we have posted many blogs devoted to this topic, so we thought it was time to create a whitepaper focusing on the topic.

In an effort to promote innovation while protecting the population at large, FDA has been on a path to revise the existing regulatory pathway surrounding the 510(k) process for medical devices for several years. This continues to be an area of many questions and considerations. In fact, we’ve devoted a whitepaper to these issues to help researchers understand the 510(k). Recently FDA released a Draft Guidance on the eCopy Program for Medical Device Submissions. While this system is currently voluntary, the draft guidance gives industry an idea of what might be in store for device submissions.

It wasn’t too long ago that new recommendations for improving the 510(k) medical device review processes were published with the goal of installing a pre-review assessment that would check applications and reject submissions dibbed incomplete.  FDA took steps forward with this plan and released the FDA Draft Guidance: Refuse to Accept Policy for 510(k)s (RTA).

 “One reason I think it’s going to change is we’re starting to see change already.” This statement was made by FDA Head, Dr. Margaret Hamburg, after meeting with senators and med-tech leaders about industry concerns. According to an article by the Star Tribune, the overall tone after the meeting was optimistic and hopes that the FDA Safety and Innovation Act signed into law will help loosen the logjam for approving medical devices.

Rep. Edward Markey, D-Mass., and Sen. Jeff Merkley, D-Ore., are pressing FDA to make it clear on the public 510(k) when a device has been the subject of a recall due to a serious design flaw.  In a letter the legislators build their case why increasing transparency in federal databases would help prevent flawed medical devices from coming to market, and hopefully help prevent serious patient injury.

A 510(k) is a premarket submission made to FDA to demonstrate that the device to be marketed is at least as safe and effective, that is, “substantially equivalent”, to a marketed device. For devices that are low to moderate risk but are found to be “not substantially equivalent” to a predicate device, the de novo classification process provides a possible route to market.

Currently 510(k) applications are used to approve investigational devices that are largely equivalent to devices that the FDA has already approved. According to an article in MassDevice, The FDA issued new recommendations for improving the 510(k) medical device review process by installing a pre-review assessment that would check applications and reject submissions dubbed incomplete. The details can be found in FDA Draft Guidance: Refuse to Accept (RTA) Policy for 510(k)s.

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.

Discussion on the FDA’s 510(k) program remains a very popular topic.  According to an article in MD+DI, industry groups are urging major changes on the FDA’s draft on evaluating substantial equivalence in 510(k)s.  Not surprisingly, Public Citizens is asking the agency to delay the guidance because they feel it’s overly permissive.

The new 510(k) guidelines released by the FDA aim to provide transparency and predictability for companies that are seeking lower-risk device approval through the 510(k) pathway.  Since the initial draft guidance was released, critics have argued that these proposed changes could negatively impact industry, raising the R&D costs to bring a non-significant risk device to market and potentially pushing jobs out of the US as companies strategically look for less cumbersome routes of approval. With the release of the official less cumbersome guidelines, new critics have emerged, stating that the American public ends up the big loser due to the concessions that the FDA made, purportedly as a result of pressures from Congress and industry.

A new pilot program that started this month may bring about noticeable changes in 510(k) reviews. Starting in April 2012 and running until October 2012 the FDA is testing The Triage Pilot Program. According to the website, the objective is to reduce the review time of Traditional 510(k) applications that are of good quality as incentive to sponsors to submit such applications.

According to Ed Markey, D-Mass, the FDA needs stricter regulation of medical devices and to end the 510(k) pathway to approval. As a result of this belief, the congressman introduced the Safety of Untested and New Devices Act (SOUND) to close the 510(k) pathway, or as Markey refers to it, the regulatory loophole. This act aims to “ensure that new medical devices are not cleared by the FDA if they are based on a product that was recalled because it caused serious harm to patients,” according to the press-release.

In an effort to promote innovation while protecting the population at large, the US Food and Drug Administration (FDA) has for several years been on a course to revise the existing regulatory pathway surrounding the 510(k) process for medical devices. One topic of concern focuses upon clinical data.

We ran across this interesting article in MD+DI.  According to a report released by the Emergo Group, the average time it takes to obtain 510(k) clearance has risen steadily in recent years.  The findings in the report indicated that the average number of days from submission to clearance increased every year from 2006 to 2010.

Back in October, Reuters reported that the FDA is seeking public input on a plan to create a network of outside experts to help understand the new technology in medical devices. The goal of panel would be to help speed up device approvals.