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Scott Gottlieb wrote in a May 9 blog post that the agency will propose a new rule that will blend its Quality System Regulation with international quality systems standard ISO 13485. Gottlieb claims the new rule would "harmonize domestic and international requirements, and modernize the regulation," while making sure that device-makers "adhere to high, internationally accepted quality systems."
Latest From United States, Policy & Regulation
The US Trade Representative office's decision in March to include devices, imaging machines and diagnostics on a list of Chinese imports destined for a 25% tariff has riled up the industry. A half-dozen medtech organizations protested the move in comments and testimony this week, supplying USTR with 12 reasons why the tariffs are a very bad idea.
There is “not sufficient evidence” of a widespread public health concern relating to servicing of devices, including by third-parties, according to an FDA report; the agency sees no immediate needs to issue new regulatory requirements for the third-party servicers. The agency also intends to issue guidance to help clarify the difference between “servicing” and “remanufacturing."
In an overhaul of a regulation that sets out how US FDA designates combo products to product centers, the agency is proposing to update its policies so they align with current practices and mandates. FDA is also specifically proposing to streamline a designation appeal process that it says has been a burden for all parties.
More than 80 industry, laboratory, health-care provider and patient groups sent a letter to two congressional committees, urging them to advance a bill to modernize the current way FDA regulates diagnostic tests, including possibly a new regulated product category that combines laboratory developed tests and in vitro diagnostics.
An ostomy supply manufacturer can give free samples to potential clients without violating anti-kickback rules, the US Department of Health & Human Services’ Office of the Inspector General wrote in a recent advisory opinion.
In prepared remarks shared with Medtech Insight, AdvaMed plans to argue that tariffs imposed on medtech products made in China would disrupt an ongoing "action plan" the industry is pursuing to achieve reciprocal market access between the US and China for the industry.
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