Disclosure, Registration and Regulations: What You Need to Know
Posted Apr 28, 2011 in Management
The globalization of our profession and growth in outsourcing--both domestic and offshore--has raised a number of concerns among laboratory owners, one of which is the issue of disclosure. If you're using subcontractors--domestically or offshore--do you legally have to let your dentist-clients know where the case was made?
With the August 2005 passage of the Medical Device User Fee Stabilization Act*, Congress has answered this question, explained NADL Executive Director Bennett Napier during his presentation at the annual CAL-Lab Group meeting in Chicago in February. "If a medical device is not manufactured by you, you must identify it as such. So if the case is fabricated by another laboratory, you must either label it as "Manufactured by [Name of lab] and distributed by [Your Lab Name]" or just "Distributed by [Your Lab Name]," said Napier. "This applies to both domestic and internationally outsourced restorations."
Enforcement of this Act comes under the auspices of the FDA. Napier also answered several other commonly asked questions about FDA regulations and how they apply to laboratories:
Who has to register with the FDA?
"For the most part, domestic laboratories don't have to register with the FDA at this time," said Napier. Those who must register with the FDA and submit 510(k) pre-market forms for the product manufactured include:
All domestic and foreign laboratories that repackage or relabel material, such as porcelain, or that fabricate sleep apnea or snoring devices (or any other medical device that is not part of the core dental lab function).
All foreign dental laboratories shipping into the U.S.
All U.S. brokers or agents for foreign dental labs shipping into the U.S.
Who has to comply with the FDA's Quality System/Good Manufacturing Practice regulations?
All U.S. laboratories must comply with the QS/GMP. In effect since 1997, these regulations are outlined in Title 21 Part 820 of the Code of Federal Regulations, often referred to as "21 CFR Part 820." The GMP requirements are wide ranging and relate to all manufacturers; the 21 CFR Part 820 regulations are specific to medical device manufacturers, which include dental laboratories. Simply put, 21 CFR Part 820 specifies that you must have an established, documented "quality system for the design, manufacture, packaging, labeling, storage, installation and servicing of finished medical devices intended for commercial distribution in the U.S."
However, the confusing aspect of the QS/GMP regulations is that each laboratory owner must determine which of the regulations apply to his business; there is not an absolute checklist on how to comply. "Some labs have to comply with 100% of the regulations, while others may only have to comply with 70%. It depends on your individual operation and which of the manufacturing activities regulated by the QS/GMPs you engage in. For example, if you don't repackage or relabel materials, you don't need to comply with those specific regulations," said Napier. "Although the FDA had talked of developing a guidance document for dental laboratories, that has been put on the back burner so, for now, dental labs are on their own."
Who is exempt from the FDA regulations addressed above?
"Licensed denturists and dentists are exempt from FDA registration, QS/GMP regulations and labeling disclosure requirements; the distinction being that they both manufacture and deliver medical devices," said Napier.
The Medical Device User Fee Stabilization Act is an amendment to the Federal Food, Drug, and Cosmetic Act. Click here to download a PDF of the Act.
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