Radiation-Emitting Medical Devices

by | Feb 22, 2021 | FDA, Medical Devices, Quality, Radiation

If you are a manufacturer of a radiation-emitting medical device, then 21CFR 820 is not the only regulation that you need to comply with. Title 21 of the Code of Federal Regulations, Parts 1000 through 1050 (21 CFR 1000 – 1050) contains radiation safety regulations for manufacturers of radiation-emitting electronic products. These regulations ensure that manufacturers are responsible for producing products that do not emit hazardous and unnecessary radiation.1

If you are a manufacturer, importer, or distributor of a radiation-emitting medical device then you are required to submit the following records to CDRH in accordance with 21 CFR 1002:1

  • Product Reports
  • Annual Reports
  • Abbreviated Reports
  • Supplemental Reports

 

Along with the submission of these reports, manufacturers are responsible for:1

  • Design of the product in accordance with the performance standards applicable under 21CFR1000.
  • Following quality control practices in the manufacture of the product to ensure appropriate testing programs are in place such that no hazardous or unnecessary radiation exposure occurs.
  • Each unit manufactured in compliance with the performance standard has a certification label with the applicable performance standard and is affixed to the product.

 

How should you submit these reports to the FDA?

Radiation emitting product reports can be submitted to the FDA in three ways: electronically through the FDA Gateway, by mail, or electronically via email. Additionally, radiation-emitting products being imported into the United States are required to complete form 2877, which is the required imports form for radiation-emitting electronic products.1

Manufacturers of electronic medical devices usually miss out on these additional requirements when designing their compliance program. Have you considered compliance to 21CFR 1000-1050 for your product?

If not, we are here to help! Give us a call at +1 248-987-4497 or email us at info@emmainternational.com to know more.


1FDA (January 2021) Radiation-Emitting Products Industry Assistance: Walk-through retrieved on 02/12/2021 from https://www.fda.gov/radiation-emitting-products/getting-radiation-emitting-product-market-frequently-asked-questions/radiation-emitting-products-industry-assistance-walk-through

Nikita Angane

Nikita Angane

Solutions Delivery Specialist - Ms. Angane is a Bioengineering graduate with experience in medical device commercialization, product development, quality system compliance and regulatory affairs. Her portfolio includes working on medical devices, combination products, and pharmaceuticals. As a Solutions Delivery Specialist at EMMA International, she offers her expertise to help our clients achieve an effective and sustainable quality system, and develop regulatory strategies for market access and compliance of new products in the US and international markets. Ms. Angane earned a Bachelor of Engineering in Biomedical Engineering from the University of Mumbai, India and an M.S. in Bioengineering from University of Illinois at Chicago.

More Resources

Pattern Recognition as a Quality Superpower

Pattern Recognition as a Quality Superpower

There are always new ways and reasons to apply pattern recognition to quality improvement. Better ensuring patient outcomes in health care facilities and improving accuracy for medical diagnoses are two such frontiers.
Record Control for a Regulated World

Record Control for a Regulated World

In a regulated industry, the prevailing posture of regulatory representatives, in my experience, has been “Show me proof.” In fact, the philosophy I’ve heard repeated by regulators is “If it wasn’t documented, it didn’t happen.”

Ready to learn more about working with us?

Pin It on Pinterest

Share This