FDA should tailor new pre-market requirements for infusion pumps to the complexity and risks of different pump types, manufacturers say.

The agency proposed several new requirements for infusion pump 510(k) submissions, including clinical evaluations and pre-clearance manufacturing facility inspections, in April 23 ¹ draft guidance released as part of the agency's broader infusion pump initiative (² Also see "FDA To Impose New Pre-market Requirements On Infusion Pump Makers" - Medtech Insight, 3 May, 2010.).

But industry stakeholders say the infusion pump landscape is too diverse for across-the-board guidelines.

"Infusion pumps encompass a wide breadth of device types, including drug delivery and enteral infusion pumps, electromechanical and non-electrically driven pumps," device trade group AdvaMed wrote in July 26 ³ comments. "Use, environment and risks are not equal."

The Medical Device Manufacturers Association similarly urged in July 23 ⁴ comments that "final guidance should recognize the unique characteristics of various infusion pumps [and] provide data in support of any new recommendations."

Tailored 510(k) Requirements

AdvaMed says FDA should adopt a "two-tiered" regulatory approach for lower- versus higher-risk infusion pump types. The risk level would be determined by the type of fluid the pump delivers, the pump's purpose, electromechanical design and the environment in which it is used.

Tier-one pumps would include fluid pumps with low potential risk, such as enteral feeding, anti-infective and post-operative pain management pumps, and would be subject to fewer pre-market requirements, AdvaMed suggested.

For example, the guidance recommends pump manufacturers submit an "assurance case report," in which claims about the safety and effectiveness of the device are supported by evidence and arguments, to demonstrate that new or changed devices are substantially equivalent to their predicates.

Assurance case reports have been used in the nuclear power and aerospace industries, but never before in the medical device field.

For low-risk pumps, AdvaMed urged FDA to accept risk management reports or hazard analyses in lieu of assurance case reports. In addition, FDA should eliminate certain 510(k) submission requirements, such as design requirements documents and accept simulated use testing in lieu of real-use evaluations, the group proposed.

Tier-two pumps would be higher-risk pumps and could be subject to the additional pre-market requirements, AdvaMed said.

The National Home Infusion Association ⁵ agreed that clinical studies should not be required to validate enhancements to low-risk infusion pumps.

Siddarth Desai of drug-delivery device maker I-Flow proposed separate, simplified guidelines for non-electrically-driven pumps, such as elastomeric pumps, in July 9 ⁶ comments.

According to the FDA draft guidance, most changes or modifications to infusion pumps will significantly affect the safety and effectiveness of the devices and require submission of a new 510(k).

Device makers said that assumption was too broad.

Not all changes will be significant, commenters argued, and they urged FDA to refer to its own guidance on when to submit a new 510(k) for modifications to existing devices.

"Infusion pump manufacturers no longer have clear guidance as to how the agency views modifications or changes to infusion pumps," AdvaMed wrote.

Guidance Would Introduce Pre-510(k) Inspections

The draft guidance also says FDA may conduct a pre-clearance inspection for infusion pumps. Pre-approval inspections are standard for PMA products, but not for 510(k)-cleared devices.

"FDA finds that there is a substantial likelihood that failure to comply with the Quality System Regulation (part 820) for these products will potentially present a serious risk to human health," the document explains.

FDA will take certain factors into consideration when deciding to inspect, such as whether it is a new device, whether a facility inspection has not taken place in the last two years or the previous inspection found violations, and whether the infusion pump was changed to address failures.

MDMA warns that pre-clearance inspections that are not prompted by safety concerns are "an inefficient use of FDA resources and would delay patient access to new therapies."

AdvaMed says the guidance should clarify how quickly the pre-clearance inspections will occur, and whether they will take priority over other inspections in the compliance office's queue.

Regulations, Implementation Issues Spark Debate

FDA says the guidance, when finalized, will likely be converted to a special controls regulation.

AdvaMed warned that a special control is "premature at this time."

MDMA also urged FDA "to further test and mature the concepts presented in the guidance document before giving additional consideration to implementing a special control."

Guidance, rather than regulation, allows the agency more flexibility to update its thinking, the groups concluded.

In any case, FDA has indicated that the elements of draft guidance will be made effective "immediately," but firms are requesting transition periods of up to five years.

"FDA should provide a reasonable amount of time for medical device companies to comply with the guidance," MDMA wrote.

Immediately imposing the new requirements violates FDA's "good guidance practices," the association added.

Because some of the requirements, such as assurance case reports, are completely new to industry, they "will require a significant transition period from existing methods," diabetes product firm Novo Nordisk ⁷ wrote July 23.

AdvaMed recommended a 12-month transition period to implement the new requirements, including "extensive training" of industry and FDA reviewers on the new methodology. MDMA requested at least 18 months to transition, while Novo Nordisk suggested allowing up to five years to fulfill the new requirements.

MDMA also noted that the draft guidelines should not apply to 510(k) submissions currently pending before FDA.

"Requiring these companies to 'start over' in the pre-market notification process would negatively impact patient access" and potentially shutter many small companies, MDMA cautioned.

FDA launched the infusion pump initiative to address persistent problems with infusion pump performance across manufacturers.

According to the draft guidance, from 2005 to 2009, FDA received more than 56,000 Medical Device Reports associated with infusion pump use, of which 1% involved deaths and 34% involved serious injuries.

- Jessica Bylander ( ⁸ j.bylander@elsevier.com )

New FDA Requirements Should Not Apply To All Infusion Pumps, Firms Say

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