The U.S. Food and Drug Administration (FDA) recently sent a reminder to medical device establishments that had not yet registered for 2017. FDA requires establishments involved in the production or distribution of medical devices intended for use in the United States to register their establishments annually between October 1 and December 31. The registration fee for the fiscal year (FY) 2017 is $3,382, which is a decrease from the fee for FY 2016 of $3,845.
A majority of the establishments that must register with FDA must also list their devices and the activities performed on those devices. A list of who is required to register, list, and pay fees can be found here. It is a prohibited act to manufacture or distribute devices in the United States without a valid FDA registration. Therefore, it is prudent for any device establishments that plan to continue business in the U.S. in 2017 to renew their registration as soon as possible.
FDA has deemed certain establishments and devices are exempt from registering due to low risk to patients and the role they play in advancing digital health. The product codes of devices that meet the exemption requirements are:
- LMB – Device, Digital Image Storage, Radiological
- LMD – System, Digital Image Communications, Radiological
- NFF – Device, Storage, Images, Ophthalmic
- NFG – Device, Communications, Images, Ophthalmic
- OUG – Medical Device Data System
- NXQ – Daily Assist Devices
Establishments dealing with the devices listed above should not list these devices with FDA during their 2017 registration.
Registrar Corp is a U.S. FDA consulting firm that helps businesses comply with FDA regulations. Registrar Corp can help device establishments determine their applicable FDA registration requirements as well as register establishments and list devices with FDA. You can reach Registrar Corp by phone at +1-757-224-0177 or our Regulatory Advisors are available 24-hours a day online at www.registrarcorp.com/livehelp.