FDA Releases Draft Guidances on Gene Therapies
The FDA unveiled six new draft guidances outlining its latest thinking on the rapidly evolving field of gene therapy including two that address the development of combination products and retinal disorder devices. Read More
Trump Tariffs Hurt Medical Device Manufacturers
The Trump Administration followed through on its threat to impose tariffs on Chinese made-products including medical devices on July 6, announcing a 25 percent tax on $34 billion worth of imported Chinese products. Read More
Devices News
FDA Shoots Down Petition on Tyvaso Referencing Combination Products
The FDA denied a United Therapeutics petition urging the agency to reject ANDAs for combination products referencing the company’s hypertension drug Tyvaso (treprostinil). Read More
Minnesota Devicemaker Hit for Procedural Issues
The FDA issued Summit Medical a Form 483, citing issues with CAPA and incoming product acceptance procedures as well as process validation shortcomings. Read More
Devicemaker Sybaritic Flagged for Failing to Follow Consent Decree
The FDA cited device manufacturer Sybaritic of Bloomington, Minnesota following a Feb. 22 to March 7 inspection for failing to comply with the terms of a consent decree. Read More
AdvaMed Says Abbreviated 510(k) Guidance Needs More on Device Types
The FDA should clarify which device types will be eligible for its abbreviated 510(k) pathways, AdvaMed said in a written comment on the agency’s draft guidance. Read More