As FDA moves to establish an accelerated development program for breakthrough devices, it is getting diverging input on how expansive the program should be. Industry insists that the agency is thinking too small, while others say FDA must take care to ensure the program is limited and tightly controlled.

CDRH issued a draft guidance in April proposing the new program called the “Expedited Access Premarket Approval Application for Unmet Medical Needs for Life Threatening or Irreversibly Debilitating Diseases or Conditions,” or EAP. The goal is to speed up the path from product prototype to market launch for PMA devices that would address a serious unmet patient need.

Consumer and industry groups alike support that general objective, but do not necessarily agree on how broad-based such the accelerated access program should be and how often it should be applied.

The agency proposes to accept less statistical certainty to support premarket approval for qualifying products if a sponsor and FDA can map out, at the preclinical stage, a long-term data plan that includes rigorous postmarket evidence collection to fill any gaps. For EAP devices, FDA says it will devote significant resources collaborating with qualifying sponsors in the preclinical phase to help establish the plan, and will require that companies submit a “data development plan” to be accepted into the program. (See Also see "Leap Ahead With EAP? FDA Proposes New Expedited PMA Pathway" - Medtech Insight, 22 April, 2014..)

The EAP program is based in part on the device center’s Innovation Pathway, currently employed for select devices targeting end-stage renal disease. (See Also see "CDRH Launches ‘Innovation Pathway 2.0’ With End-Stage Renal Devices" - Medtech Insight, 16 April, 2012..)

AdvaMed Wants “True Call To Action”

That all sounds encouraging, but it barely scratches the surface as to what is needed, AdvaMed suggests in comments submitted to the agency on the EAP draft guidance on July 22.

“We are concerned that ... few products will successfully go through the program” – AdvaMed

“We are concerned that, like earlier initiatives such as the ‘Innovation Pathway,’ which was a “priority review program for pioneering medical devices,’ few products will successfully go through the program,” Sharon Segal, AdvaMed’s VP- Technology and Regulatory Affairs, writes for the device trade association. “To address unmet medical needs for life threatening or irreversibly debilitating diseases or conditions in a timely manner, a true call to action is necessary.”

CDRH Director Jeffrey Shuren told “The Gray Sheet” in April that he expects, at least at first, only about six devices per year to qualify for the program. (See Also see "FDA Hopes To Balance Upfront Time Investment With Easier Reviews In New PMA Program" - Medtech Insight, 23 April, 2014..)

But AdvaMed says FDA should make the program more flexible, and questions some of the agency’s core EAP criteria. In particular, the device group argues that acceptance into the program should not depend solely on whether there is preclinical agreement with FDA on a data development plan and whether the balance between premarket and postmarket data requirements could be changed. The association argues that there are alternative pathways for accelerating development of high-need products that should also be considered.

Further, AdvaMed questions FDA’s basic tenet the expedited access program should be limited to PMA devices. “The EAP program should be expanded to include devices subject to 510(k) submissions, or a similar program be developed to accommodate 510(k) products,” Segal writes.

The written comments suggest the trade group is attempting to generate a more detailed proposal for an expanded expedited access program, but a spokeswoman said the group could not comment further on the effort.

The trade group also said that while the intention of an EAP process is to speed up the path to market, there is potential that some of the requirements – for example, to establish a long-term data plan or designate a cross-disciplinary case manager – could add more rather than less layers of review. AdvaMed notes that the draft guidance does not specify any timelines for guiding the EAP-related processes and interactions.

AdvaMed also wants FDA to make clear that it is not only completely new devices that are eligible for EAP treatment, but that new indications of approved devices could also make the cut.

Pew: Nice Plan, But Be Careful

But while companies want to push the envelope, FDA is, in parallel, hearing a message urging caution. That message is being delivered, most prominently, by The Pew Charitable Trusts. The well-known non-profit’s medical device initiative has positioned itself as a clearinghouse for discussion on device regulatory issues and an advocate for policies that it says will improve device safety, and also policies that improve access to new products.

“If manufacturers do not meet these [postmarket study] deadlines, FDA should automatically begin proceedings to revoke approval of the device” – Pew

“Devices designated for expedited approval should be the exception – not the rule,” writes Josh Rising, director of medical devices for Pew, in July 22 comments to FDA. “FDA must work with patients, physicians, consumers and payers to ensure that the criteria used to select devices appropriately reflect only the highest priorities for improving patient care.”

Pew says it supports FDA’s proposal to reduce development times for high-need devices, noting that the EAP draft guidance, along with a co-released draft on balancing premarket and postmarket data, “generally strike the right balance between accelerating the development of medical devices for patients with serious, unmet needs while also ensuring the safety and effectiveness of new technologies.” But, Rising writes, additional protections may be needed.

The central compromise to the EAP program is that FDA will agree to less premarket certainty in exchange for vigorous postmarket data. That setup is only appropriate, Rising suggests, if the postmarket data are collected and submitted in a timely manner and if there are consequences for data that is not submitted or inadequate.

Pew urges FDA to establish specific timeframes for companies to start and complete postmarket studies. And, “If manufacturers do not meet these deadlines, FDA should automatically begin proceedings to revoke approval of the device,” Rising writes.

The agency should also evaluate whether it has sufficient authority to promptly withdraw approvals when needed, and, if not, work with Congress to gain the needed powers, according to Pew.

The non-profit’s comments also advise FDA to consider “special controls” for EAP-approved devices modeling the Risk Evaluation and Mitigation Strategies (REMS) program for drugs. The controls might include required special training for physicians or a mandate for doctors to document care in a registry, Rising writes.

Pew also emphasizes the importance of an improved device postmarket surveillance system to support the EAP program as outlined in FDA’s National Medical Device Postmarket Surveillance Plan and its unique device identification program. (See Also see "CDRH Details Path Forward For National Post-Market Surveillance System" - Medtech Insight, 29 April, 2013..)

Rising said Pew comments were informed by several recent meetings and webinars convened by the company with government agencies, patient groups, physicians and industry among others.

Both the AdvaMed and Pew comments responded to FDA’s July 22 public input deadline. According to regulations.gov, FDA has received a total of 12 public comments as of July 24, but none have been posted online. The AdvaMed and Pew comments were obtained directly from the respective organizations.

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