On January 2023, The U.S. Food and Drug Administration (FDA) published Radiological Health Regulations for Recording and Reporting Radiation Emitting Electronic Products and Performance Standards for X-ray, Laser and Ultrasonic Diagnostic Products.
The FDA is amending and repealing parts of the radiological health regulations covering recommendations for radiation protection during medical procedures, certain records and reporting for electronic products, and performance standards for diagnostic x-ray systems and their major components, laser products, and ultrasonic therapy products.
The Agency is taking this action to clarify and update the regulations to reduce regulatory requirements that are outdated and duplicate other means to better protect the public health against harmful exposure to radiation emitting electronic products and medical devices.
The new rule takes effect as of February 21, 2023.
About the Final Rule and Changes Include
Repealed the performance standard for ultrasonic products and radiation protection recommendations for specific uses:
- Revised timing of submissions of reporting accidental radiation occurrences (AROs) allowing manufacturers to submit quarterly summary reports of AROs that are not associated with a death or serious injury and not required to be reported under the medical device reporting regulations (§ 1002.20; part 803).
- Manufacturers are no longer required to submit two additional copies of applications for variances process (§ 1010.4(b)).
- Reduced reporting requirements, under certain conditions, for manufacturers that incorporate a certified laser product.
- Removed requirements for manufacturers to report model numbers of new models of a model family that do not involve changes in radiation emission or requirements of a performance standard in quarterly updates to their annual reporting (§ 1002.13(c)).
- Assemblers who install certified components of diagnostic x-ray systems are no longer required to submit a report of assemblies, Form FDA 2579, to CDRH and instead will only be required to submit such reports to purchasers and applicable State agencies.
- Amended applicability of the recordkeeping requirements for dealer and distributor records (§ 1002.40 and §1002.41).
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About Global Regulatory Partners
Global Regulatory Partners Inc, (GRP) is an American company that provides regulatory affairs, clinical, quality and safety services to medical devices, pharmaceutical, cosmetic and Food Supplement companies globally.
GRP headquarters is located in Massachusetts USA and its main affiliates are located in China, Japan, Brazil, Mexico & Korea.
GRP helps many life science companies register their products in different countries in compliance with local regulations.