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The U.S. Food and Drug Administration (FDA) removed 2,546 medical device establishments from its active registration database.  As of February 19, 2018, the FDA database contained 24,578 registered establishments, compared to 27,124 registered establishments on February 2, 2018.

Why Were These Registrations Removed?

Establishments are typically removed due to failure to renew their annual FDA registrations.  FDA requires medical device establishments to renew their registrations between October 1 and December 31 of each year.  Within two or three months, FDA typically removes any establishments that do not properly renew.

Establishments located outside of the United States must designate a U.S. Agent for FDA communication as part of their annual registration.  During the recently passed renewal period, listed U.S. Agents were required to confirm their designation with FDA.  If a U.S. Agent failed to confirm their designation, FDA did not consider the establishment’s registration complete.

Marketing a medical device in the United States without a valid FDA registration is a prohibited act that may result in detention or refusal of shipments and other FDA enforcement actions.  Many establishments do not realize that their FDA medical device registration is invalid until their shipments are detained.

Registrar Corp can verify that your FDA medical device registration is valid for 2018 at no cost. Simply complete the form below.  For questions or assistance with FDA medical device regulations, call: +1-757-224-0177 or chat with a Regulatory Advisor 24/7: regstaging.wpengine.com/livehelp

Verify your FDA Registration:

Medical device manufacturers commonly question whether the U.S. Food and Drug Administration (FDA) considers their product a medical device “component” or “accessory.”  Given that accessories can be classified separately from the parent devices they function with, the distinction is important.  In December, FDA issued a guidance on accessory classification policy that helps clarify this distinction.

Component or Accessory?  What is the Difference?

CFR 21 820.3(c) defines a “component” as “any raw material, substance, piece, part, software, firmware, labeling, or assembly which is intended to be included as part of the finished, packaged, and labeled device.”  For example, a stethoscope contains multiple parts, including a diaphragm, bell, and tubing.  When packaged in whole with the stethoscope, these parts would be considered medical device components that comprise a finished medical device.

In contrast, FDA clarifies that an “accessory” is a separate, finished device intended to “support, supplement, and/or augment the performance” of at least one parent device.  Accessories might be marketed individually for use with a specific device type and may be a different class than their parent device.

For instance, an endoscope, which is used to examine a patient’s internal organs, receives its own medical device classification.  An individually marketed endoscopic snare may be attached in order to remove harmful objects from a patient during endoscopy.  Because the snare is marketed for intended use with a parent device and it supplements the parent device by adding functionality, the device would likely be considered an accessory.

Likewise, cushions for motorized wheelchairs are often marketed separately with the intent to address specific physiological concerns of the device user.  The cushion augments the parent device by improving convenience for the device user.  While the motorized wheelchair may be a class II device, the cushion may present lower risk when used with the parent device.  Dependent on FDA’s assessment of this risk, the cushion might be considered a class I medical device accessory, subject to different requirements than its parent.

FDA’s New Accessory Classification Process

FDA generally determines classification of accessories in one of two ways.  An accessory may be included in the same classification as its parent device through 510(k) Premarket Notification, Premarket Application, or express inclusion in the classification regulation of the parent device. Other cases may involve the issuance of a separate classification regulation when FDA considers an accessory to have a different level of risk than its parent device.

The FDA Reauthorization Act of 2017 allows for the classification of accessories based upon the level of risk posed when used as intended and the level of regulatory controls necessary to provide reasonable assurance of safety and effectiveness.  Manufacturers may now submit an Accessory Classification Request to FDA to receive appropriate classification of their device accessory.  An Accessory Classification Request includes a proposal to FDA that, among other aspects, identifies the accessory, the proposed class of the accessory, and the necessary information to establish the risk the accessory poses.

Medical device classification serves an important role in deciding a device’s FDA requirements, such as the premarket processes it may be subject to or when it is required to comply with certain regulations.  Lower device classes may even receive exemption from certain premarket requirements.

For proper accessory classification, Registrar Corp’s Regulatory Specialists can guide you through compiling the documentation required for a FDA Accessory Classification Request.  Additionally, if you manufacture an accessory and would like to preserve trade secrets from the manufacturer of the parent device, we can assist in the submission of a Medical Device Master File to FDA.  For more information, call us at +1-757-224-0177 or chat with a Regulatory Advisor 24/7 at regstaging.wpengine.com/livehelp.