Businesses should reevaluate the classification of their clinical decision software based on a new FDA guidance, Kyle Faget of Foley & Lardner LLP tells Medtech Insight.
Clinical decision software (CDS) manufacturers may be “upset” due to necessary re-evaluation from the Food and Drug Administration’s final draft guidance on CDS, says Foley and Lardner partner Kyle Faget.
Faget, co-chair of the firm’s healthcare and life science practice groups, spoke to MedTech Insight about the new guidance and...
The FDA has released draft guidance clarifying UDI rules for drug- and device-led combination products. The document specifies labeling requirements and makes recommendations to reduce confusion between UDIs and NDCs. Comments are being accepted until Sept. 24.
The US FDA recently published a draft guidance document for manufacturers of mesh products that are used during several types of hernia repair procedures.
FDA moves forward with implementing previous draft guidance and will consolidate forms, but the agency estimates limited impact in the total reporting burden.
The US FDA's new draft guidance details the responsibilities of new owners of 510(k) clearances, including making timely updates device listings in FURLS and GUDID to maintain accurate information for safety alerts and recalls. Comments on the draft are accepted until 4 August.
