FDA webinar Oct. 31 on proposed rule for laboratory developed tests 

Oct 18, 2023 - 02:16 PM
Cybersecurity woman IT professional

On Oct. 31 at 1 p.m. ET, the Food and Drug Administration will host a webinar to review its recent proposed rule for laboratory developed tests, which would amend the agency’s regulations to require most laboratory developed tests to meet the same medical device requirements as other in vitro diagnostic products. Participants may email questions for consideration to CDRHWebinars@fda.hhs.gov until Oct. 23.

Related News Articles

Headline
GAO recommends FDA, CISA update medical device security documentation based on AHA input
The Government Accountability Office Dec. 21 recommended the Food and Drug Administration and Cybersecurity and Infrastructure and Security Agency update a 5-…
Headline
Report offers ways to address cybersecurity challenges posed by legacy medical devices 
The Food and Drug Administration on Nov. 16 announced a new report from government contractor MITRE, Next Steps Toward Managing Legacy Medical Device…
Headline
FDA approves first sterilization system for 3D-printed medical devices
The Food and Drug Administration the week of Aug. 7 cleared for marketing the first sterilization system for 3D-printed devices in health care facilities. The…
Headline
FDA updates sterilization standards for medical device makers
The Food and Drug Administration the week of July 24 updated its recognized consensus standards database for medical devices to advance innovation in medical…
Headline
EPA proposes new standards for ethylene oxide sterilizing facilities
The Environmental Protection Agency today proposed requiring commercial sterilization facilities to comply within 18 months with stricter emission and…
Headline
FDA releases FAQs on new requirements for medical devices vulnerable to cybersecurity threats
Effective today under the Consolidated Appropriations Act of 2023, medical devices seeking approval from the Food and Drug Administration must meet certain…