According to a presentation by FDA official Blake Bevill, two recent laws will impact the device industry:

1. 1. Food and Drug Administration Re-Authorization Act (FDARA) of 2017
2. 2. 21^st Century Cures Act

FDARA Highlights

The FDA Reauthorization Act of 2017 (FDARA), an amendment to the Federal Food, Drug, and Cosmetic Act, was passed to revise and extend the user fee programs for drugs, medical devices, generic drugs, and biosimilar biological products.  There are nine FDARA titles.  The first five deal with drug and device user fees, and Title VII makes significant changes in the law to enhance FDA’s medical device inspection process. 

Changes to the Medical Device User Fee Amendment (MDUFA):

The FDA will increase fees with the goal of increasing speed and efficiency in reviewing new devices and in improving safety and effectiveness of marketed devices.  Changes include:

• 37% increase in establishment registration fee
• 33% fee increase for PMAs and PMA supplements
• 125% fee increase in 510(k)
• Small businesses get a break on 510(k) fees; increase for them is only 12.6%
• Beginning in FY 2018, FDA will charge a new user fee for de novo submissions

Starting Fiscal Year 2018, there is a new statutory requirement to apply an inflation adjustment to the user fee(s) annually.

Device Inspection & Regulatory Highlights

• The FDA is switching from biennial inspections to a risk-based schedule to inspect Class II and III devices.
•  The Agency is required to update its processes and establish uniformity for its routine inspections (not for cause), i.e., provide advance notice of inspection and allow for advance communications within a “reasonable timeframe,” notify manufacturer of the type and nature of the inspection; estimate timeframe of the inspection; communicate in advance the records to be requested; establish regular communication during the inspection on the status of the inspection.
• The FDA is directed to prepare a draft guidance on its implementation of this provision by February 18, 2019.
• In responding to 483s, device manufacturers often have difficulty obtaining feedback from the FDA regarding proposed corrective actions on whether these actions are considered enough by the Agency. The FDA is now required, upon request from the manufacturer, to provide “nonbinding feedback” within 45 days if the request is “timely” and the corrective actions relate to public health, systemic or major actions, or an emerging safety issue.

FDARA Inspection Refusals

• Devices are now considered adulterated if a manufacturer delays, denies, limits the bounds, declines entry, or refuses an inspection.
• If a device manufacturer wants to limit the bounds of an inspection and the investigator disagrees, the investigator may report this as a “refusal.”

FDARA Certificate to Foreign Government (CFG) Issuance

The FDA recently issued a seven-page draft guidance, “Process to Request a Review of FDA’s Decision Not to Issue Certain Export Certificates for Devices.” Highlights from the guidance state: 

• When a company has a bad inspection at a U.S. facility, the FDA has the right to refrain from issuing CFGs, which allow manufacturers to renew licenses and permit them to sell in foreign markets.  It can take a year or more for the FDA to reissue CFGs because the facility is not in substantial compliance with the Quality System Regulation (QSR).  In the past, manufacturers have had little to no indication of when CFGs might be refused or what it takes to resolve it. FDA is now required to provide a written explanation for denying a CFG unless the basis is an injunction, seizure, or Class I or II recall.
• The new law prohibits the denial of CFGs based solely on 483 observations if the firm “has agreed to a plan of correction.”
• The FDA is also required to develop a process to review any new information presented by a firm in response to a CFG denial

21^st CENTURY CURES ACT

Passed in December 2016, the 21^st Century Cures Act is intended to improve the regulatory process for medical devices.  The law is impacting device companies in a variety of ways:

• Breakthrough Device Program – provides priority review for devices for life-threatening conditions that currently have no known treatment.
• Humanitarian Device Exemption Program – expands this program, which allows approval for devices indicated for rare diseases.
• Recognition of Standards – the law requests that the FDA provide a written response within 60 days to any party requesting recognition of a standard established by the recognized standard organization.  The Agency’s response must include a rationale for recognizing or not recognizing parts, all, or none of the standard.
• Review Class I and II Devices – every five years the FDA will be required to review Class I and II devices for 510(k) exemption and publish the list of device types.
• Classification Panels – the FDA will be required to ensure that personnel have “adequate expertise” to assess the disease that the device is indicated to cure, treat, prevent, or diagnose.  Manufacturers will have an opportunity to recommend what sort of expertise the panelists will need. Annually, patients and their representatives, as well as sponsors of devices, will have the opportunity to recommend clinical experts to fill the panel positions.
• Institutional Review Boards – prior to the 21^st Century Cures Act, Institutional Review Boards (IRBs) were required to be at every center in multicenter device trials; now manufacturers need only one IRB to oversee a multicenter trial.
• Clinical Laboratory Improvement Amendment (CLIA) – the FDA will replace the requirement to demonstrate the accuracy of in vitro diagnostic devices based upon a gold standard.  This will make it easier for some IVD tests to be exempted from CLIA requirements, e.g., routine inspections.
• “Least Burdensome” – the FDA reviewer will be required to receive training “regarding the meaning and implementation of the least burdensome requirements” and the Agency will also make sure that these requirements are applied, and if the FDA requests information from a PMA applicant, the Agency “shall consider the least burdensome appropriate means necessary to demonstrate a reasonable assurance of device safety and effectiveness.”