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FDA to hold public meeting on hearing aids and audio-enhancement devices

BY Michael Johnsen

SILVER SPRING, Md. – The U.S. Food and Drug Administration on Wednesday announced new efforts to better understand how the agency can appropriately balance patient safety while encouraging advancements in hearing aid technology and access to these devices in the United States. The FDA will convene stakeholders for a public workshop on April 21 and has re-opened a public comment period on a draft guidance related to the agency’s premarket requirements for hearing aids and personal sound amplification products.
 
According to statistics compiled by the National Institute on Deafness and Other Communication Disorders, 37.5 million adults aged 18 and older in America report some form of hearing loss. However, only 30% of adults aged 70 and older and 16% of adults aged 20 to 69 who could benefit from wearing hearing aids have ever used them. 
 
“The FDA recognizes that hearing aids are an important and often underutilized medical device for those with hearing impairment,” stated William Maisel, acting director of the Office of Device Evaluation in the FDA’s Center for Devices and Radiological Health. “Additional insight from all stakeholders will help us to better understand how we can overcome the barriers to access and spur the development of devices that compensate for impaired hearing.”
 
Most hearing aids are regulated as Class I (low-risk) medical devices and are generally exempt from premarket review and clearance by the FDA before marketing. Hearing aids are, however, required to comply with general regulatory controls used to ensure the safety and effectiveness for medical devices. A report from the President’s Council of Advisors in Science and Technology recently recommended possible modifications to the FDA’s regulation of hearing aids that the council believes could “enhance the pace of innovation” and lead to a “decrease in cost and improvement in capability, convenience and use of assistive hearing devices.” As a result of the report, the FDA is further engaging stakeholders to consider how best to ensure that its regulations and policies are clear, up-to-date and well-understood, and that they both protect the public and foster innovation in this area.
 
The FDA is also reopening its comment period on a draft guidance that clarifies the difference in regulatory requirements between hearing aids and PSAPs—wearable electronic products for use by non-hearing impaired individuals to amplify sounds in certain environments. The draft guidance states that hearing aids are medical devices subject to GMPs and other QSR requirements. However, the FDA considers PSAPs to be electronic products, as opposed to medical devices, and the guidance states that manufacturers should not use product labeling or promotional materials to suggest that hearing impaired consumers should use them. In reopening the guidance, the FDA is seeking feedback on the availability, accessibility and use of hearing aids and PSAPs for consumers with hearing impairment, particularly as it relates to issues and recommendations identified in the PCAST report. 
 
The comment period for the draft guidance will be open for additional public comments through May 19, 2016.
 
 
 
 
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EPA update to waste management regs mark ‘important step forward’

BY Michael Johnsen

ARLINGTON, Va. – Five retail associations on Tuesday expressed optimism regarding proposals by the Environmental Protection Agency to update waste management regulations that may impact how unsold consumer products and pharmaceuticals are handled by retailers. But more needs to be done, the associations noted. 
 
EPA's application of the Resource Conservation and Recovery Act, which governs the disposal of hazardous waste, to "the very small percentage" of unsold consumer products that may be recycled, reused or otherwise discarded from a retail store represents a challenge for the retail community, the associations argued. 
 
“This [regulation update] is an important step forward and the retail associations welcome the opportunity to respond to these long-awaited proposals," stated Sue Pifer, VP compliance at the Retail Industry Leaders Association. "Although portions of the proposals may offer some relief, the suggested frameworks fall short of easing the burden on retailers who want to manage unsold products in a more sustainable fashion, rather than discarding potentially useful or recyclable items,” she said. “The retail associations again emphasize in their comments that most unsold consumer products and pharmaceuticals are not ‘wastes’, due to the fact that many are suitable for re-shelving, donation, recycling, liquidation or shipment back to vendors for credit.”
 
Specifically, EPA's proposed rules:
 
  • Allow a waste generator to avoid increased burdens of a higher generator status when generating large quantities of hazardous waste “episodically,” or unexpectedly and infrequently. Such episodes may be the result of broken or damaged customer returns, theft or damage within the store, public dumping in trash receptacles or recalls of unusable products;
  • Allow very small quantity generators to consolidate hazardous wastes from multiple locations at a “large quantity generator” site, such as a distribution center, thereby eliminating the disproportionate regulatory burdens of a higher generator status at store-level, provided certain conditions are met; and
  • Allow health care facilities to manage hazardous waste pharmaceuticals under tailored, sector-specific regulations, and relax the requirements for managing empty pharmaceutical containers. 
 
EPA is also soliciting comment on potential amendments to the heightened “acute” hazardous waste classification for smoking cessation products, like low-concentration nicotine patches, gums and lozenges, which subjects retailers to  additional in-store requirements.
 
Reverse distribution involves the removal and consolidation of consumer products and pharmaceuticals that are not sold in retail stores and is a long-standing business practice that is friendly to the environment and good for consumers, the associations noted. The practice pre-dates the arcane application of RCRA to retailers’ reverse distribution operations.
 
In 2014, RILA led a coalition of retailers to explain the challenges of complying with RCRA, and some of the issues raised by the coalition were addressed in the proposed rules, released by the EPA in September 2015.
 
In addition to RILA, the retail associations include the Food Marketing Institute, the National Association of Chain Drug Stores, the National Grocers Association and the National Retail Federation. 
 
 
 
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