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This comprehensive resource covers product change evaluation, postmarket surveillance, audit/inspection compliance, and various other laws and regulations pertaining to maintaining a product on the market.
Hear from leaders around the globe as they share insights about their experiences and lessons learned throughout their certification journey.
| 30 October 2012 | By Alexander Gaffney, RAC
The third and latest iteration of the Medical Device User Fee Act may be the most important yet, said panelists participating in a discussion at 2012 RAPS in Seattle, WA.
The act, known colloquially as MDUFA III, was passed into law in July 2012 as part of the Food and Drug Administration Safety and Innovation Act (FDASIA), a sprawling piece of healthcare legislation that looks to overhaul and enhance many of the US Food and Drug Administration's (FDA) processes and abilities.
Whereas earlier iterations of the law-MDUFA I and II, respectively enacted in 2002 and 2007-were primarily focused on replicating the Prescription Drug User Fee Act (PDUFA) model to channel much-needed resources to FDA, MDUFA III puts a much greater emphasis on accountability from regulators, said panelists.
Still, the law comes with new funding as well-and lots of it. Between 2013 and the end of 2017, FDA will receive $595 million in user fees from industry, a combination of higher fees and new sources of income.
But what will that money pay for? Barbara Zimmerman, deputy director for premarket program management at FDA's Office of Device Evaluation (ODE), is glad you asked.
"This agreement strikes a careful balance between what industry agreed to pay and what we can accomplish with the additional funding," said Zimmerman at 2012 RAPS session on MDUFA.
Zimmerman said earlier versions of the law had been unrealistic in asking for FDA to meet goals without providing it with an appropriate amount of funding. Under the MDUFA III, FDA will have the resources it needs to accomplish mutually beneficial goals, she said.
Susan Alpert, principal at SFA Consulting and an industry negotiator on MDUFA III, agreed. "We wanted a deal where FDA would get a significant and stable increase in funding in return for meeting reasonable and meaningful goals. In the end, that's what we got."
"We got a good-a very good-deal from MDUFA III," continued Alpert, citing the specific changes under the law. She said the negotiations were significantly more difficult than those of MDUFA II, and cited industry's hesitancy coming out of MDUFA II as one of the biggest sticking points. Regulators, she said, had not been able to hold up their end of the bargain on that legislation. Negotiations on the third iteration of the law were thus focused on the creation of realistic expectations for both parties and the mechanisms needed to accomplish those expectations.
In return for user fees, FDA will be expected to institute a number of agreed-upon changes, explained Zimmerman. The main changes will see FDA instituting process improvements to make it more predictable, consistent, transparent, efficient and timely. Additional changes will see the hiring of new staff and review managers, tighter review goals and even shared outcome goals.
Importantly, stressed Zimmerman, 90 of the 97 staff hired so far under MDUFA III have been review staff within the Center for Devices and Radiological Health (CDRH)-not the Office of the Commissioner or other FDA oversight departments. The hiring of additional staff-240 over the next five years-will also reduce the reviewer-to-manager ratio, she said, giving industry quicker review times. New and existing employees will be given training, be subject to a certification program and will undergo at least 16 hours of training on MDUFA.
Other changes are structured to give industry the assurance that no application is languishing at FDA without consequence. A new program, dubbed "No Submission Left Behind," is intended to introduce accountability for those applications that missed their decision goal dates. Previously, some of those applications were put aside by staff looking to make sure other applications didn't miss their MDUFA goal dates. The new method will emphasize communication with the applicant shortly after the Tier 1 goal is missed in the hopes of providing more feedback, and FDA staff will be more accountable for decisions as well.
Another accountability change will allow FDA to better assess its adherence to MDUFA III goals overall. Unlike previous years, FDA will now used a "trimmed mean" metric that excludes the highest and lowest 2% of submissions from the average total time to decision metrics for 510(k) submissions, and 5% for Premarket Applications (PMAs). This will also allow FDA to close its cohorts earlier, allowing it to communicate its performance history much more quickly. Before, approval cohorts could be held up for years by a single stalled application, preventing the release of accurate data.
As part of MDUFA, FDA is charged with developing-and has in some cases already released-guidance on "refuse to accept criteria" for both PMAs and 510(k)s. The new guidance, "Is intended to focus premarket resources on complete applications," Zimmerman said. "This approach will provide a more efficient approach to ensuring that safe and effective medical devices reach patients as quickly as possible."
Under the new approach, FDA can "refuse to accept" (RTA) any application that does not meet an objective set of criteria, though industry has responded to the first draft of the guidance by stating that it is too subjective to be used as intended. The new approach, said Zimmerman, "Is intended to focus premarket resources on complete applications."
"With the new performance goals established in MDUFA III, acceptance review takes on additional importance in both encouraging quality applications from applicants and allowing reviewers to appropriately concentrate resources on complete applications," she added. Submissions that fail to meet acceptable standards will not trigger the start of the FDA review clock.
Once an application is deemed to be complete and accepted, FDA said its Interactive Review process will, similar to PDUFA V, attempt to minimize the number of review cycles that a product is subject to by increasing the amount of agency-industry interactions and consultation.
FDA will continue to resolve any outstanding deficiencies via the Interactive Review process, or will communicate to the applicant that it has identified deficiencies that warrant placing the submission on hold, explained Zimmerman.
Zimmerman also said FDA is working on other pre-submission process guidance and requirements for specific product types relative to their submission pathways (IDE, PMA, 510k, etc). Some low-risk devices will come to be exempted from premarket notification requirements under these requirements, while others-particularly diagnostic products-will receive more regulation.
In addition, FDA will soon develop guidance documents regarding an improved process for developing, tracking and updating its guidance documents-meta-guidance, if you will-in the hopes of instituting a more structured approach allowing for more stakeholder input.
Yet another guidance on FDA-industry communication is in the process of being drafted and will be released shortly, Zimmerman added.
Another important change, outlined in a draft guidance released in October 2012, is the eCopy system. Under MDUFA, industry will be required to format its applications using an electronic format. The guidance comes into effect on 1 January 2012, and Zimmerman reminded the audience that any submissions made without the use of the eCopy system will not be accepted.
Zimmerman said that eCopy is intended to reduce the amount of time FDA needs to reformat information to enter it into its databases, and should also make the review of applications more consistent and accurate.
"DocMan"-CDRH's Document Manager, a system that will create a repository of information for each application-will also radically change the way FDA converses with sponsors, predicted Zimmerman. Under the DocMan system, all review memos, checklists, correspondence, emails and approval packages will be automatically be copied to a unique email address. In other words, sponsors can rest easy knowing their emails are easily accessible to a reviewer and are not lost in a sea of unread emails, said Zimmerman.
The DocMan system will also correspond with some security upgrades. FDA will be launching a new digital signature policy in November 2012, allowing for more secure communications on sensitive information. Zimmerman said they have been testing the new secure system for a while now and feel confident that it will be a smooth transition and benefit all parties involved.
Tags: FDASIA, MDUFA, Latest News, medical device