HHS/FDA Make It Official: Premarket Notification Required For 7 Types Of Class I Medical Gloves
A joint final order from the US Department of Health and Human Services and the Food and Drug Administration says makers of the low-risk gloves must have 510(k) clearance before sending their products to market.
You may also be interested in...
The agency has rescinded two previous notices issued by HHS, stating the FDA had no input on the notices before they were published and the rationale backing them was flawed.
The US HHS and the FDA on 14 January published a notice that permanently waives premarket notification requirements for seven types of gloves that were given temporary waiver during the pandemic. Regulators are looking to expand the waiver to 84 other products.
Device makers presented with an affidavit by the US FDA during a facility inspection should walk away as quickly as possible, King & Spalding partner Jessica Ringel advises.