Question 1

What types of products does United Regulatory support?

Accepted Answer

We support medical devices (Class I-III), cosmetics, OTC drugs, dietary supplements, and combination products for both the U.S. (FDA) and Canadian (Health Canada) markets.

Question 2

How long does a typical 510(k) submission take?

Accepted Answer

A well-prepared 510(k) typically takes 3-6 months to prepare and 90 days for FDA review. We work to streamline the process and avoid Refuse to Accept letters.

Question 3

What is MoCRA and does it affect my cosmetics business?

Accepted Answer

MoCRA (Modernization of Cosmetics Regulation Act) requires all cosmetic companies selling in the U.S. to register facilities and list products with FDA. Yes, it likely affects your business if you sell cosmetics in the U.S.

Question 4

Can you help with Health Canada submissions?

Accepted Answer

Absolutely. We handle Medical Device Licence (MDL) applications, MDEL establishment licences, Cosmetic Notification Forms (CNF), and DIN/NPN applications for drugs and natural health products.

Question 5

What is the cost of your regulatory consulting services?

Accepted Answer

Costs vary by project scope. We offer a free initial consultation to assess your needs and provide a detailed proposal with transparent pricing. Contact us for a custom quote.

Question 6

Do you help with FDA import alerts?

Accepted Answer

Yes. We assist companies in resolving import alerts, preparing evidence packages, and working with FDA to restore importing privileges.

Question 7

What is UDI and is it required for my medical device?

Accepted Answer

UDI (Unique Device Identification) is an FDA system requiring most medical devices to carry standardized identifiers. Requirements vary by device class, with specific compliance deadlines.

Question 8

Do you offer ongoing compliance support after market clearance?

Accepted Answer

Yes. We provide post-market surveillance support, adverse event reporting guidance, annual registration renewals, labeling updates, and ongoing regulatory monitoring.

Question 9

What is DSHEA and how does it regulate dietary supplements?

Accepted Answer

DSHEA (Dietary Supplement Health and Education Act) is the primary U.S. law governing dietary supplements. Unlike drugs, supplements don't require FDA pre-market approval, but manufacturers must ensure safety, comply with cGMP regulations (21 CFR Part 111), register their facilities, and substantiate any structure/function claims with scientific evidence.

Question 10

Do dietary supplement companies need to register with FDA?

Accepted Answer

Yes. All domestic and foreign facilities that manufacture, process, pack, or hold dietary supplements for U.S. sale must register with FDA biennially. Failure to register is a prohibited act under the FD&C Act.

Question 11

What is a New Dietary Ingredient (NDI) and when is a notification required?

Accepted Answer

A New Dietary Ingredient is any dietary ingredient not marketed in the U.S. before October 15, 1994. Before selling a supplement containing an NDI, you must submit a safety notification to FDA at least 75 days prior to marketing. We prepare complete NDI notifications including safety evidence packages.

Question 12

What are structure/function claims and how do I use them legally?

Accepted Answer

Structure/function claims describe how a nutrient or ingredient affects the body (e.g., 'Supports immune health'). To use them legally, you must have competent scientific evidence, notify FDA within 30 days of first marketing the product, and include the mandatory disclaimer stating the claim has not been evaluated by FDA.

Question 13

Does FSMA apply to dietary supplement manufacturers?

Accepted Answer

Yes. Dietary supplement facilities are subject to FDA's Food Safety Modernization Act (FSMA) requirements, including food facility registration and, in many cases, the Preventive Controls for Human Food rule (21 CFR Part 117). They are also subject to the dietary supplement-specific cGMP regulations under 21 CFR Part 111.

Question 14

How do I get a Health Canada NHP product licence for my supplement?

Accepted Answer

You must submit a product licence application through Health Canada's NHPOLS system, providing evidence of safety and efficacy (traditional use, literature, or clinical data depending on product class), along with full ingredient and labeling details. The facility must also hold an NHP Site Licence. We handle the full application process from strategy through approval.

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