Sep 4, 2016

When medical devices are cleared or approved for sale in the US, manufacturers are informed that they are expected to comply with all applicable US medical device requirements, including quality system requirements. Inspections of foreign establishments pose unique challenges to FDA—both in human resources and logistics.

Beefing up QSR inspection resources

While FDA publishes its inspection guidelines, the agency does not make available to the public its inspection program indicating which medical device establishments it will inspect. FDA does not routinely inspect manufacturers of Class I devices (1), although it may do so when there are areas of concern. The FDA currently lacks adequate resources to inspect more than a small percentage of foreign manufacturers of Class II and Class III devices each year; however, the agency is adding more capability for inspections, as it recognizes the need to perform more inspections.

As a result of past lack of resources, some foreign manufacturers have marketed their devices in the US for many years without having undergone inspections by the FDA, and in some cases without having to ensure compliance with the US Quality System Regulation (QSR, also known as 21 CFR Part 820). Some of these manufacturers believe that conformity to the voluntary standard ISO 13485, Medical devices— Quality Management Systems (QMS)—Requirements for regulatory purposes, will be sufficient to successfully pass a US FDA facility inspection. They may also believe that ISO quality system certification and surveillance audits are sufficient enough to prepare for FDA inspection.

These assumptions are generally incorrect. A foreign manufacturer may have been marketing its devices in the US for some time without an FDA inspection, and therefore may not have an adequately designed quality system that meets QSR requirements. Thus, when undergoing its first FDA inspection, the manufacturer may be surprised by the number of noncompliance areas cited. It may also be that the manufacturer has not recognized that FDA inspectors and ISO quality system auditors have differing priorities in their inspections and assessments.

Preparing for an FDA QSR inspection

The FDA generally notifies manufacturers about a week in advance of post-market quality system inspections of US-based facilities, and between two to four weeks in advance for foreign establishments.

Preparing for an FDA inspection should be an organized activity involving all company personnel performing work covered by the QSR, including:

  • Executive management
  • Design and development
  • Production
  • Quality control and assurance
  • Warehousing
  • Purchasing
  • Human resources
  • Packaging and distribution
  • Information technology

Topics that manufacturers should consider during their preparation efforts should include:

  • The basic regulatory framework upon which FDA inspections are based—US law, which differs in significant ways from requirements governing European quality system audits conducted by Notified Bodies;
  • Compliance efforts for FDA regulations and requirements to be examined during the inspection; such examinations are not limited to the FDA QSR;
  • Being cognizant of QSR provisions that differ from ISO 13485 components
  • Carefully reviewing US Quality System Inspection Techniques (QSIT), which are used by FDA investigators as the basis for medical device facility inspections.

Before, during and after an inspection by the FDA, a manufacturer should also take into account behaviors—including behaviors to be avoided—by all personnel.

It is important to note that materials that can be used to develop such an inspection preparation program are readily available from many sources, including most notably from the FDA website.

Regulations covered during an FDA QMS inspection

Manufacturers should avoid the misconception that FDA inspections consist only of an assessment of QSR compliance. Inspections also examine compliance with the following regulations:

  • Medical Device Reporting (MDR) (21 CFR Part 803)
  • Corrections and Removals (21 CFR Part 806)
  • Establishment Registration and Device Listing (21 CFR Part 807)
  • Medical Device Tracking, where applicable (21 CFR Part 821)

In addition, Electronic Records and Signatures (21 CFR Part 11) may be evaluated, as well as Electronic Products compliance (21 CFR 1020, et. Seq.).

Incident reporting requirements

Incidents in which a device may have caused or contributed to a death or serious injury must to be reported to FDA under the Medical Device Reporting (MDR) program. Some foreign manufacturers fail to develop procedures to ensure that MDR requirements are met because they assume that the US importer alone is responsible for adverse event reporting. This is incorrect as “all manufacturers of finished medical devices and components which are ready for use, including foreign manufacturers, are now subject to the requirements of the MDR regulation, despite registration status,” according to the FDA.

A similar error is sometimes made regarding compliance with corrections and removal requirements. Although the manufacturer or importer can submit corrections or removals reports to the FDA, the manufacturer needs to ensure that proper procedures have been implemented to comply with these and other US importation requirements. Failure to do so could jeopardize the regulatory compliance status of the device and, in serious cases, the continued import of the device into the US. Reports of corrections and removals are required for Class I and Class II device recalls. Under 21 CFR 806, manufacturers and importers need not report events categorized as Class III recalls under 21 CFR §7; only record keeping requirements would apply.

Keeping listings current

Manufacturers should always ensure that their Device Establishment Registrations and FDA Unified Registration and Listing System (FURLS) listings are current. The manufacturer of a tracked device also should ensure that US importers and distributors are fulfilling the requirements in 21 CFR Part 821, because failure to comply with tracking requirements may cause the device to be detained at the US point of entry. Firms should verify that their listings are up-to-date every six months and update them as needed. The firm should renew its annual registration as required by 21 CFR Part 807.


Preparing for an impending FDA inspection requires a well-organized program, and is vital to a successful outcome. One excellent way to achieve preparation is to engage independent parties to perform a “mock audit” that will give the organization experience in reacting to real-life FDA inspection. Knowing what to expect can save hours of anxiety.

Linda Chatwin is Senior Customer Solutions Consultant at UL, and oversees the company’s North American Advisory Services group.


  • Linda Chatwin