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Set Alert for Policy and Regulation United States

US FDA Commissioner: Agency Will Propose New Rule That Blends Quality System Regulation, ISO 13485

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."

FDA Quality Control Standards
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Latest From United States, Policy & Regulation

Industry Gives US Trade Rep 12 Reasons Why Tariffs on Chinese Medtech Imports Are A Bad Idea

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.

Trade Policy

No New Regulations Needed For Third-Party Servicers Of Devices, FDA Says

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."

Diagnostic Imaging Quality

US Combo Product Designation Appeal Process Refined In Proposed Rule

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.

Combination Products Regulation

Labs, Test Makers Urge Congress To Pass Diagnostic Reforms

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.

In Vitro Diagnostics Legislation

Watchdog OKs Ostomy Company Samples

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.

United States Enforcement

AdvaMed To Plead With USTR To Spare Medtech In China Tariffs

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.

Trade Policy
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