FDA Proposes Uniform Inspection Guidelines

Posted April 2, 2019

The Food and Drug Administration (FDA) has issued draft guidance that recommends uniform processes and standards for not-for-cause inspections of medical device establishments. The guidance establishes a five-day notice period for domestic medical device manufacturers, defines the expected length of inspections, and details how the agency intends to communicate with manufacturers.

The content of the draft guidance was required under Section 702 of the FDA Reauthorization Act of 2017 and is intended to improve the inspection process for medical device establishments.

According to the draft guidance, domestic medical device manufacturers should receive a phone call at least five days prior to an inspection that describes the type, nature, and scope of the visit, as well as identifies “some records that may be requested.” Notifications for foreign medical device manufacturers may take longer, according to the guidance, due to potential clearance issues.

The draft guidance defines a "reasonable estimated timeframe" for inspections as three to six business days. The duration of the inspection will depend on the scope and complexity of the investigation, as well as staff availability and the nature of any observed deficiencies.

“Updated processes provide that, unless an investigator or the firm identifies a reason that additional time is needed and communicates this verbally to the other party, inspections of both domestic and foreign device establishments should take place within a standard timeframe and occur over consecutive business days,” the FDA wrote, adding that circumstances may require exceptions to that timeframe, which should be “communicated verbally during the course of the inspection.”

In addition, FDA inspectors are expected to make “every reasonable effort to discuss all observations with the management of the establishment as they are observed, or on a daily basis, to minimize errors and misunderstandings.”

In the past decade, the FDA has increased its annual number of device manufacturing establishment inspections. According to an agency report, domestic inspections increased 46% between 2007 and 2017, while foreign inspections increased 243% during that timeframe.