Device Standards Program Seeks More Input From Industry, Standards Groups
This article was originally published in The Silver Sheet
Executive Summary
FDA's MEDICAL DEVICE STANDARDS PROGRAM will involve more partnering with industry and standards development organizations in order to encourage greater use of standards in premarket applications. The device center recently unveiled new operating procedures for prioritizing standards as well as a list of top items for collaboration with standards groups. Industry representatives cite problems with declaring conformance to standards and lack of support form corporate upper management as the chief reasons standards use is not more widespread. [A discussion on integrating standards into the design process by J&J standards expert Mike Schmidt is included.]
You may also be interested in...
US Q1 Consumer Health Earnings Preview: Label This One Historic And Challenging But Promising
US OTC drug and supplement firms’ reports of results for the first three months of 2024 began on April 19 with P&G. JP Morgan analysts say while “some retailers in the US in particular” are reducing consumer health inventories, for the overall sector they expect “a healthier balance of positive volume and lower pricing contribution.”
Keeping Track: Cancer Approvals From Lumisight Imaging To Adjuvant Alecensa
The US FDA’s approval of Lumicell’s optical imaging agent Lumisight makes a dozen novel approvals in 2024 for the Center for Drug Evaluation and Research.
Partisan Politics Returns To US FDA Congressional Oversight
The US FDA has stood out as an agency that tends to draw broad bipartisan support amid a generally rancorous and divided Congress. A House hearing, however, may be a sign that those days are over.