Medtech Insight is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction
UsernamePublicRestriction

DENTAL MERCURY RECLASSIFICATION PROPOSAL SLATED FOR LATE SPRING

This article was originally published in The Gray Sheet

Executive Summary

DENTAL MERCURY RECLASSIFICATION PROPOSAL SLATED FOR LATE SPRING publication in the Federal Register, Lireka Joseph, acting director of the device center's office of training and assistance, told a Feb. 12 meeting of FDA's dental products advisory panel. The proposed rule would regulate the elemental mercury component of dental amalgam and the powder alloy component "as a single Class II product." Currently, the elemental mercury component is regulated in Class I, while the powder alloy, which is composed of silver, tin and copper, is regulated in Class II. The proposed rule follows the recommendation of the Public Health Service outlined in a report on dental amalgams released Jan. 21. The PHS committee maintained that "although sufficient data do not presently exist to establish dental amalgam as a human health hazard," the risk potential warrants further attention and the mercury component should be subject to a higher level of regulation ("The Gray Sheet" Jan. 25, p. 17). In conjunction with the Federal Register notice, the agency plans to send a letter to manufacturers of dental amalgam informing them of FDA's recommendation that "that the use of mercury in dental offices be confined to [use in a pre-mixed] encapsulated form." This letter is expected to be completed by the office of device evaluation by early April. In addition, dentists known to be using devices that titrate amalgam with mercury "will be strongly encouraged to switch to encapsulated forms," according to Joseph. FDA also plans to issue a regulation requiring producers of restorative dental devices containing metal alloys "to disclose their product ingredients" in the labeling, listing them "in descending order of percent of weight composition, but without listing the actual percentage of each component," Joseph said. PHS had recommended in the Jan. 21 report that labeling for all restorative dental materials list product ingredients. The labeling regulation would allow dentists to "shift to a substitute material if a reaction occurred, or avoid a substance if a pre-existing allergy condition was known" in a patient, according to Joseph. Prior to issuing the regulation, FDA will send a letter "to all manufacturers of dental devices that are composed of metal alloys which are intended to remain in the oral cavity for an extended period of time, strongly recommending" that the proposed changes in labeling be made voluntarily. Another PHS recommendation to be addressed by FDA involves an effort to improve the reporting of adverse incidents with dental products. Joseph said that FDA would try "to be more proactive in encouraging health professionals and patients to report adverse effects of all restorative material and devices." FDA plans to "more actively publicize" their problem reporting program "through journal articles, presentations, correspondence and discussions with professionals and consumers," she noted. Underreporting of adverse events related to dental devices also was addressed in a presentation made by FDA Commissioner David Kessler, who called for improved communication between the dental community and FDA as well as heightened enforcement.

You may also be interested in...



Pandemic-Related Price-Gouging Would Be False, Misleading Advertising Under House, Senate Bills

House and Senate Democrats sponsor legislation to authorize FTC enforcement against sales of "consumer goods and services at an unconscionably excessive price during the" COVID-19 pandemic. "It’s outrageous that some companies and individuals are taking advantage of consumers by price-gouging," says Energy and Commerce Committee Chairman Frank Pallone.

COVID-19 Trial Changes Are “Propulsive Force” For Digital Adoption

Robert Califf, a former FDA commissioner turned Verily Life Sciences exec, is just one of the voice predicting a long-term impact on clinical trial processes from the COVID-19 outbreak.

Digital Doublespeak: The Language Barrier When Tech Companies Meet Regulators

A US National Academies meeting on digital health technology showcased the communication gap between regulators and tech developers when it comes to important concepts like “digital biomarkers.”

UsernamePublicRestriction

Register

MT000229

Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel