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  • Regulatory NewsRegulatory News

    FDA announces stronger warnings on breast implant labels

    The US Food and Drug Administration on 27 October announced new labeling, including boxed warnings, to facilitate informed consumer decision-making regarding the risks of breast implants.   FDA is also restricting the sale and distribution of breast implants to providers who agree to provide patients with adequate information on their risks by reviewing a decision checklist with patients. The physician performing the breast implant must sign the checklist, and patien...
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    Asia Regulatory Roundup: Australia Suspends Sales of Eight Breast Implants After Safety Review

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia.   Australia Suspends Sales of Eight Breast Implants After Safety Review   Australia’s Therapeutic Goods Administration (TGA) has suspended the sale of eight breast implants after finishing its review of the safety of the product class. The action gives affected manufacturers a chance to meet patient safety requirements, but TGA thinks there are likely grounds to perman...
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    RoundupsRoundups

    Asia Regulatory Roundup: TGA Updates Guidance on the Testing of Biological Medicines

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia.   TGA Updates Guidance on the Testing of Biological Medicines   Australia’s Therapeutic Goods Administration (TGA) has updated its guidance on testing biological medicines. Version 2.0 of the guidance features new details on the use of TGA in-house orthogonal testing methods and other changes.   TGA published the first, and until this week only, version of the guid...
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    RoundupsRoundups

    Asia Regulatory Roundup: TGA Proposes Ban on Certain Breast Implants

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia.   TGA Proposes Ban on Certain Breast Implants After Safety Review   Australia’s Therapeutic Goods Administration (TGA) is planning to cancel the licenses of nine Natrelle textured breast implants made by Allergan. TGA proposed the action, plus the suspension of 16 other devices, after reviewing evidence of links between breast implants and a form of lymphoma.   Ove...
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    FDA Panel Recommends New Postmarket Requirements for Breast Implants

    As part of efforts to make breast implants safer, the US Food and Drug Administration (FDA) should consider additional postmarket data reporting requirements on breast implant manufacturers, the agency’s General and Plastic Surgery Devices Panel suggested after a two-day meeting. On whether to remove textured breast implants from the US market as other countries have done, the panel argued data is lacking to support such a recommendation as it would reduce options for p...
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    CDRH to Review Materials Used in Medical Devices

    Following recent high-profile safety issues related to materials used in implantable and insertable medical devices, US Food and Drug Administration (FDA) Commissioner Scott Gottlieb and Center for Devices and Radiological Health (CDRH) Director Jeff Shuren on Friday announced plans to improve the agency’s approach to evaluating material safety and biocompatibility.   “Modernizing the regulatory framework pertaining to the FDA’s review of medical device materials requi...
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    How Price Caps in India are Forcing US Device Companies to Sell Stents and Implants at a Loss

    Hypothetical talk circulating on Capitol Hill this week around the idea of price ceilings for certain pharmaceuticals set off alarm bells for industry. But on the medical device side, companies are already seeing what happens when a government, in this case India, sets price caps for certain devices and mandates that companies remain in the market and take a loss on sales. The situation in India has reached a point where the Advanced Medical Technology Association ...
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    Asia Regulatory Roundup: India Orders J&J and Others to Maintain Output of Knee Implants (3 October 2017)

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia. India Orders J&J, Other Device Makers to Maintain Output of Knee Implants The Indian government has ordered Johnson & Johnson and a clutch of other device makers to maintain output of knee implants at pre-August levels. Officials invoked the legislation to stop the companies from cutting production in response to the price ceiling the government brought into force in ...
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    Asia Regulatory Roundup: China’s Supreme Court Clarifies Legal Scope to Punish Trial Data Fraudsters (22 August 2017)

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia. India Fixes Price of Orthopedic Knee Implants, Tells Manufacturers to Maintain Supply India has capped the price of orthopedic knee implants. The imposition of ceiling prices continues the National Pharmaceutical Pricing Authority’s (NPPA) push to control the cost of medical devices sold in India. Months after setting limits on the prices of coronary stents, NPPA has ...
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    FDA Concurs With WHO on Rare Lymphoma Linked to Breast Implants

    The US Food and Drug Administration (FDA) on Tuesday said it now concurs with the World Health Organization’s designation of an association between breast implants and the development of anaplastic large cell lymphoma (ALCL), a rare type of non-Hodgkin's lymphoma. "Since 2011, we have strengthened our understanding of this condition and concur with the  World Health Organization designation  of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) as a rare...
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    EU Court of Justice Clarifies Product Liability for Notified Bodies

    The European Court of Justice (ECJ) last week issued its long-awaited judgement on a case that heavily influenced the new revisions of the EU's Medical Device Directives. But the court's decision was more about clarifying the role of notified bodies in a product liability case concerning faulty breast implants made by the now-defunct French manufacturer Poly Implant Prothese (PIP) and German notified body TÜV Rheinland than about deciding if the notified body was liable....
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    Dutch Report Finds Silimed Breast Implants Carry Little Risk to Patients

    Particle contamination on the surface of breast implants made by Brazilian devicemaker Silimed poses, at worst, a "one in a million" risk to patients, according to a report released on Monday by the Dutch National Institute for Public Health and the Environment (RIVM). Background Last fall, EU regulators suspended all CE certificates for Silimed devices after German notified body TÜV SÜD found man-made fibers on the surface of the company's implants. After the inspec...