Medical Device Daily Washington Editor

WASHINGTON — The 2011 FDA draft guidance on when to file a new 510(k) for changes to an existing clearance drew a lot of fire, and the pushback sparked enough resistance on Capitol Hill that the draft was deleted by an act of Congress. However, a member of the Advanced Medical Technology Association (AdvaMed; Washington) said FDA's attempt to fix the flaws in the K97 memo seem to promise a document that both industry and FDA can live with.

The Advanced Medical Technology Association (AdvaMed; Washington) hosted a press briefing to review the FDA performance goals under the Medical Device User Fee Agreement (MDUFA) III, which found its way into the statute via the Food and Drug Administration Safety and Innovation Act (FDASIA) of 2012. Janet Trunzo, executive VP for technology and regulatory affairs at AdvaMed, gave some background on the negotiations that led to MDUFA III, stating, "we went into it [during] some difficult times." Among the predicaments facing industry as those negotiations commenced was that time-to-decisions were rising for both 510(k) and PMA filings. Trunzo also cited "multiple review cycles, especially for 510(k)s," noting further that additional requests for information by reviewers at the Office of Device Evaluation were at an all-time high.

AdvaMed's Ruey Dempsey, VP for technology and regulatory affairs, said during the briefing that AdvaMed members "were very unhappy" with the 510(k) changes draft, adding that the association had communicated with FDA as to how industry believed K97 should be revamped, "including considerations of how quality systems should feed into this."

"We told FDA K97 has worked pretty well all these years," Dempsey stated, but that industry was of the view that the memo needed work. However, she said AdvaMed suggested FDA "revise K97, not throw it away." She noted that AdvaMed emphasized allowing industry to "keep our decision trees" for determining whether a new regulatory filing is needed.

Decision trees, Dempsey stated, will be back, but she said they will in the future be "more specific and ask the right questions." She said the existing K97 memo has legitimate problems, noting, "sometimes the questions could be stated more clearly."

Dempsey said that industry is still of the view that the design controls portion of the quality systems regulation (QSR) is capable of addressing any concerns FDA has about whether sponsors are appropriately evaluating changes to a device. "We believe the QSR should be part of the decision making process," she said, adding, "if you're compliant . . . you've done validation and verification" of any changes.

"Even in the preamble" to K97, Dempsey pointed out, the memo "talks about the role of GMPs and a soon-to-be activated QSR" in helping to determine whether a change forces a new filing. However, she acknowledged that FDA is uneasy over the possibility that a device maker might not use the QSR to properly evaluate any changes.

"That was one of the statements FDA made" at a recent meeting, Dempsey continued. She said Christy Foreman, director of ODE, said "they don't know that a company is QSR-compliant and that's concerning for them." She remarked that the agency voiced concerns that some sponsors were using the decision tree in K97 without reading through the text, an omission that created problems for FDA.

All in all, however, Dempsey said, "we're feeling pretty positive about the direction FDA seems to be taking" regarding the memo. "We're looking forward to the report" FDA will file with Congress regarding K-97, which she said is due Jan. 9, 2014.

AdvaMed's Jeff Secunda briefly addressed FDA's unique device identifier final guidance, saying, "we give them a lot of credit for taking the deep dive and not just throwing out a regulation."

Still, Secunda said, "even after the final rule, there's plenty of work going on," including on the global UDI database (GUDID), adding, "we're coming to the close of a 60-day comment period on that."

Secunda said one of the more labor-intensive pieces of the UDI task is the global medical device nomenclature code, but he noted also that FDA wants firms to use the nine-digit number assigned to each location by Dun & Bradstreet (Short Hills, New Jersey), the so-called DUNS number. He noted that in many instances, those in a device firm who have that information "are in the financial part of the company" and not the development or regulatory side of operations.

Secunda said FDA is using DUNS numbers already, noting that it should not be too difficult to update those codes in the event of a merger or acquisition. He said there are three ways to populate the GUDID with DUNS numbers, including via a web browser, which he said will suffice for firms with just a handful of products. The other two options require the use of an HL7 protocol, "which is quite complex," according to Secunda. He said many firms will likely hire a third party to handle this requirement.

Still, he said it's not an entirely novel proposition. "The electronic [medical device report mechanism] that's been around for a couple of years uses a comparable HL7 protocol, so it's not totally new," he said.

FDA 2012 labeling guidance redone

FDA reported in the Nov. 20 Federal Register that it is redoing a 2012 guidance dealing with labeling for drug and biological products, stating that the reason for the redo was to clarify "how FDA would exercise its enforcement discretion."

The new draft, like its predecessor, is titled "Product Name Placement, Size and Prominence in Advertising and Promotional Labeling," and the FR announcement indicated that the draft deals with "human drugs, including biological drug products," as well as prescription animal drugs. Presumably the labeling mandates would apply to combination products as well.

The notice states that the draft addresses a variety of media, including traditional print media, audiovisual promotional labeling, and social media.

In addition to the question of enforcement discretion, the notice states that the new draft clarifies issues related to "intervening matter in relation to the juxtaposition of the proprietary and established name," but also that the discretion will apply to "the use of the established name on pages or spreads and offers an example of what is expected." The discretion matter will also deal with "the established name's presentation in columns" as well.

Other matters said to be addressed in the draft are the use of proprietary names in running text, but FDA said it has removed the previous recommendation that the established name be included in the audio portion of an audiovisual promotion. Another point of interest is the established name's presentation on Web pages or electronic screens.

Interested parties have until Jan. 21, 2014 to comment under docket no. FDA-1999-D-4079.

Mark McCarty, 703-361-2519

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