US FDA lays out final guidance on post-market surveillance requirements

By Stewart Eisenhart, Emergo Group

Final guidance from the US Food and Drug Administration explains post-market surveillance requirements that pertain to certain types of medium- and high-risk medical devices sold in the US.

The new requirements are based on Section 522 of the US Federal Food, Drug and Cosmetic Act, which authorizes the FDA to require post-market surveillance by manufacturers for some Class II and III devices. Following amendments to Section 522 in recent years, the agency’s latest guidance reflects these changes and explains how compliant manufacturers will be impacted.

Under Section 522, the FDA may require post-market surveillance by manufacturers in four cases:

1. For Class II or III devices that may cause serious adverse health consequences if they fail
2. For Class II or III devices with widespread use on pediatric populations
3. For Class II or III devices intended for implantation in humans for more than one year
4. For Class II or III devices intended for life-sustaining or life-saving uses outside of healthcare facilities

In early 2015, Emergo reported on a Brookings Institution study commissioned by the FDA that found the agency’s existing post-market surveillance capabilities lacking, and plagued by data backlogs and inadequate internal resources. By asserting its authority to require post-market surveillance activities under Section 522, the FDA may be moving to address some of the shortcomings noted in the Brookings Institution report.

 “Pre-522” Determinations that post-market surveillance is necessary

According to the guidance, the FDA may determine at any time during a device’s life cycle that post-market surveillance under Section 522 will be required of a manufacturer. Factors including but not only adverse event reports, recalls and corrective actions, premarket data reviews or scientific literature reviews may trigger such determinations.

The agency then assembles a “pre-522” team of personnel from various centers including the Center for Devices and Radiological Health (CDRH) to evaluate whether a 522 post-market surveillance order is truly warranted for a particular device using established criteria, and then consults with the manufacturer on their findinds.

How long does post-market surveillance need to be conducted?

If the FDA determines that post-market surveillance for a particular device is indeed necessary, the device manufacturer must conduct post-market surveillance for up to 36 months; the agency and manufacturer may agree to extend that time period. For pediatric devices, the agency may require post-market surveillance for more than 36 months without a manufacturer’s agreement if additional time is deemed necessary to determine how a particular device will impact pediatric patients.

Once the FDA has issued an order to conduct post-market surveillance, a manufacturer must initiate such activities no later than 15 months from the date of that order.

What to include in post-market surveillance submissions to the FDA

Manufacturers that must comply with 522 post-market surveillance requirements must submit significant amounts of information to the FDA, including background data on their devices; post-market surveillance plans, objectives and designs; patient populations and sample size calculations; and schedules for interim and final reports to the regulator.

Once a manufacturer has submitted its post-market surveillance plan and related information to the FDA, the agency will evaluate the submission for completeness and whether it addresses the questions raised by the 522 order. The guidance lays out further steps manufacturers may take if the agency deems their proposed post-market surveillance plans insufficient.

Interim and final reporting requirements

Following approval and launch of a post-market surveillance plan, the manufacturer is expected to provide interim reports every six months during the first two years of its plan, and then on an annual basis in subsequent years.

Final reports should be submitted to the FDA within three months of either a concluded post-market surveillance activity or termination of a 522 order.

Stewart Eisenhart covers medical device regulatory affairs for Emergo Group.

The opinions expressed in this blog post are the author’s only and do not necessarily reflect those of MassDevice.com or its employees.

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