Electronic and Radiological Devices Accession Numbers
Electronic and radiological device accession numbers are one of several parts of bring a radiation emitting product to market. Accession numbers refer to the unique FDA identifiers for electronic product reports found in FDA’s radiation emitting electronic product database. The accession number is provided in response to mandatory reporting for electronic and radiolgoical devices.
There is no public data base for electronic and radiological device accession numbers and neither can they be shared. Accession numbers apply both to medical and non-medical electronic and radiological devices. The FDA Guidance describes what products the FDA can exercise jurisdiction over:
Any product that contains an electronic circuit and generates any kind of radiation is an electronic product that emits radiation. X radiation (x-rays), microwaves, radio waves (radiofrequency (RF)), laser, visible light, sound, ultrasound, and ultraviolet light are a few examples of the many types of radiation-emitting electronic products. Diagnostic x-ray systems, laser products, laser light shows, and microwave ovens are a few examples out of the many different electronic products that emit radiation. Legal definitions of the terms “electronic product radiation” and “electronic product” are located in the Federal Food, Drug, and Cosmetic Act, Chapter 5, Subchapter C – Electronic Product Radiation Control.
When working with an eletronic and radiological device (device in the general sense and not the medical device sense) it is important to evaluate the regulations. The Center for Device and Radiological Health (CDRH) is often thought of as providing device approvals (510(k)s, PMAs, etc.), but for medical radiological devices there may be another step. Reporting, record keeping and the associated electronic and radiological device accession numbers, are all key considerations and steps for manufacturers and assemblers.
Contact our Washington D.C. or Charlotte office for more information on electronic and radiological regulations and electronic and radiological device accession numbers.
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