Dive Brief:

• FDA on Tuesday released two final guidance documents that address the agency’s regulatory standards for medical imaging equipment.
• One guidance aims to align U.S. performance standards for X-ray imaging equipment with international policy and provides recommendations for manufacturers on how to comply with the requirements. The final guidance updates a draft policy issued in August 2016.
• The second guidance covers standards for fluoroscopic equipment, clarifying aspects of U.S. performance requirements. The draft guidance was issued in September 2014.

Dive Insight:

In its guidance for manufacturers of diagnostic X-ray imaging systems, FDA said it thinks coordinating U.S. standards under the Electronic Product Radiation Control section of the Food, Drug and Cosmetic Act with International Electrotechnical Commission policy will facilitate more efficient and consistent regulatory review of product submissions.

Furthermore, conforming to IEC standards would provide at least the same level of protection for public health and safety from electronic radiation as EPRC rules, FDA said.

In comments submitted to FDA, both AdvaMed and the Medical Imaging and Technology Alliance agreed, lending their support to the use of international voluntary consensus standards to meet regulatory requirements. “Any time the agency can rely on consensus-based recognized standards, everyone benefits,” MITA said. AdvaMed noted the policy would help avoid unnecessary costs and delays in patient access to new devices.

Manufacturers and importers of X-ray imaging equipment must follow current EPRC regulations and procedures. If a company opts to conform to an equivalent IEC standard to meet an EPRC performance standard and other product reporting rules, it must complete a declaration of conformity that certifies the device meets EPRC requirements. The declaration of conformity to equivalent IEC standards is intended to help manufacturers avoid duplicating efforts.

An image-intensified fluoroscopic X-ray system is a device used to visualize anatomical structures by converting a pattern of radiation into a visible image through electronic amplification.

FDA said a 2010 public meeting on reducing radiation exposure from medical imaging made clear that some areas of the federal performance standard for fluoroscopic equipment could be clarified. Recommendations FDA received at the public meeting focused on incorporating certain features and safeguards identified in IEC standards.

Specifically, in its final guidance document, FDA clarified parts of the federal performance standard for fluoroscopic equipment covering fluoroscopic irradiation time, last-image hold, and emergency fluoroscopy mode.