FDA Looks To Reduce Regulatory Duplication With Draft X-Ray Guidance

Some X-ray imaging device companies could simply declare they are in conformance with International Electrotechnical Commission standards and avoid filing 510(k) notifications and Electronic Product Radiation Control reports with FDA, according to a new draft guidance from the US agency.

Some manufacturers and importers of X-ray imaging devices may avoid 510(k) reporting requirements if their product conforms to certain International Electrotechnical Commission (IEC) standards, according to a new US FDA draft guidance. The agency says it is trying to address complaints from manufacturers about duplicate reporting of X-ray products that need to meet its 510(k) premarket notification requirements and Electronic Product Radiation Control (EPRC) reporting.

"Conformance with recognized consensus standards may in some situations support a substantial equivalence determination," states the guidance. "Moreover, declaration(s) of...

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Medtech Insight for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required
Start Free Trial

Already a subscriber?

More from United States

Innovative Wants Injunction Against J&J Subsidiary After $442M Antitrust Verdict

 
• By Elizabeth Orr

Innovative Healthcare is asking for a permanent injunction against Johnson & Johnson subsidiary Biosense Webster after winning a $442 million antitrust verdict. The injunction aims to prevent continued anticompetitive practices in the electrophysiology catheter market.

Increasing Safety Concerns Spur Scrutiny of Device Plastics Use

 
• By Elizabeth Orr

With new regulations limiting the use of plastics popping up worldwide, the medtech industry sees arguments on both sides. Some argue hasty bans of PFAS ("forever chemicals") would harm patients, while others say phthalates should be phased out to protect the public.

With LDT Rule DOA, Could FDA Shift Focus To RUOs?

 
• By Brian Bossetta

Now that the US FDA has chosen not to appeal a March ruling effectively killing the agency’s efforts to regulate lab-developed tests as medical devices, will the agency adopt a different strategy to flex its regulatory muscle?

US FDA Unveils Plans To Consolidate Support Services

 
• By Derrick Gingery and Sue Sutter

Commissioner Martin Makary told staff that plans are being developed to centralize HR, IT, travel and other functions, which were heavily impacted by the 1 April reduction-in-force.

More from North America

A Year After Exiting The Ventilator Market, Medtronic Recalls Thousands Of Newport Devices

 
• By Brian Bossetta

After two serious injuries and one death linked to some of its ventilators, Medtronic has recalled the devices and asked customers to stop using them and find alternative means. The action comes more than a year after the company left the market.

MDUFA VI Launches With Public Meeting, Call For Comments

 
• By Elizabeth Orr

Preparations for the reauthorization of the Medical Device User Fee Amendments for 2028-2032 are underway, with the US FDA announcing a public meeting for 4 August. After negotiations with industry and other stakeholders, a draft agreement is due to Congress by 15 January 2025.

Permanent FDA Top Lawyer Expected After HHS Counsel Confirmation

 
• By Sue Sutter

Robert Foster, HHS deputy general counsel and chief counsel for food, research and drugs, is temporarily heading the Office of Chief Counsel, but a permanent appointee is expected after Michael Stuart's confirmation as HHS general counsel.