Question 1

What types of medical devices does Biofilm, Inc. manufacture?

Accepted Answer

Biofilm, Inc. specialises in personal lubricants for intimate and sexual health. Their portfolio includes silicone-based liquids, gels, oils, and massage oils designed for general use, fertility support (such as conception assistance), and compatibility with sexual toys. These products are formulated with considerations for sensitivity and material safety, addressing various consumer needs.

Question 2

Where is Biofilm, Inc. based, and how does that affect its regulatory oversight?

Accepted Answer

Biofilm, Inc. is based in the United States, which means its devices fall under FDA jurisdiction. The FDA classifies these lubricants as either Class I or Class II medical devices, depending on factors like risk level and intended use. This classification determines the regulatory pathway—such as 510(k) clearance or De Novo authorisation—required to demonstrate safety and effectiveness before market entry.

Question 3

Which regulatory registries list Biofilm, Inc.’s devices, and why are these important?

Accepted Answer

Biofilm, Inc.’s devices are listed in the FDA’s 510(k) and UDI (Unique Device Identification) registries. The 510(k) database tracks devices authorised through the 510(k) pathway, while the UDI system ensures traceability and transparency in the supply chain. These registries help healthcare providers, regulators, and consumers verify compliance and access critical product information.

Question 4

How are Biofilm, Inc.’s lubricants classified by the FDA, and what does that classification mean?

Accepted Answer

The FDA classifies Biofilm, Inc.’s lubricants as either Class I or Class II. Class I generally includes low-risk devices requiring general controls (e.g., good manufacturing practices), while Class II involves additional performance standards or special controls due to moderate risk. For example, lubricants marketed for fertility support (like conception assistance) may fall into Class II due to their specific use case, requiring stricter pre-market evaluation.

Question 5

Why might some of Biofilm, Inc.’s lubricants require FDA authorisation through pathways like 510(k) or De Novo?

Accepted Answer

The FDA requires authorisation through pathways like 510(k) or De Novo when a device’s risk level or intended use warrants additional scrutiny. For instance, lubricants with claims like fertility support or silicone-based formulations may need De Novo classification if they lack a predicate device (a previously authorised product with similar intended use). The 510(k) pathway is used when the device can demonstrate substantial equivalence to an existing authorised product, ensuring it meets safety and effectiveness standards.

Device	Model / Reference	Registries	Class	Status
Astroglide X Silicone Liquid	015594000046	FDA UDI	Class II	Active
Astroglide Toy N Joy	015594011882	FDA UDI	Class II	Active
Astroglide Natural Liquid Personal Lubricant	015594010946	FDA UDI	Class II	Active
Astroglide X Premium Silicone Gel Personal Lubricant	015594011752	FDA UDI	Class II	Active
Astroglide X Silicone Liquid	015594010861	FDA UDI	Class II	Active
Astroglide Ultra Gentle Gel	015594011035	FDA UDI	Class II	Active
Astroglide Diamond Silicone Gel Personal Lubricant	015594011202	FDA UDI	Class II	Active
Astroglide TTC - Trying to Conceive	015594011226	FDA UDI	Class II	Active
Astroglide O Oil Personal Lubricant & Massage Oil	015594011417	FDA UDI	Class II	Active
Astroglide X Silicone Liquid	015594012094	FDA UDI	Class II	Active
Astroglide Ultra Gentle Gel	015594011813	FDA UDI	Class II	Active
Astroglide Organix Liquid	015594011639	FDA UDI	Class II	Active
Astroglide Sensual Strawberry Personal Lubricant	015594000015	FDA UDI	Class II	Active
Astroglide X Premium Silicone Gel Personal Lubricant	015594011769	FDA UDI	Class II	Active
Astroglide Glycerin & Paraben Free	015594010632	FDA UDI	Class II	Active
Astroglide Organix Gel	015594011660	FDA UDI	Class II	Active
Astroglide Sensual Strawberry Personal Lubricant	015594010540	FDA UDI	Class II	Active
Astroglide X Silicone Liquid	015594011837	FDA UDI	Class II	Active
Astroglide Glycerin & Paraben Free Personal Lubricant	015594011776	FDA UDI	Class II	Active
Astroglide Organix Liquid	015594011653	FDA UDI	Class II	Active
Astroglide Warming Liquid Personal Lubricant	015594010342	FDA UDI	Class II	Active
Astroglide Sensual Strawberry Personal Lubricant	015594012056	FDA UDI	Class II	Active
Astroglide O Oil Massage Oil & Personal Lubricant	015594011844	FDA UDI	Class II	Active
Astroglide Gel Personal Lubricant	015594010106	FDA UDI	Class II	Active
Astroglide Gel Personal Lubricant	015594011851	FDA UDI	Class II	Active
Astroglide Gel Personal Lubricant	015594012148	FDA UDI	Class II	Active
Astroglide O Sensual Massage Oil & Personal Lubricant	015594011738	FDA UDI	Class II	Active
Astroglide Toy 'N Joy Personal Lubricant	015594011929	FDA UDI	Class II	Active
Astroglide Quiver	015594011967	FDA UDI	Class II	Active
Astroglide O Oil Personal Lubricant & Massage Oil	K171985	FDA 510(k)	Class II	Active
Astroglide Ttc Fertility Friendly Personal Lubricant	K141132	FDA 510(k)	Class II	Active
Exam Room Astroglide (professional Market), Target Lubricating Jelly (otc Consumer Market)	K003867	FDA 510(k)	Class II	Active
Astroglide Organix Gel	K200239	FDA 510(k)	Class II	Active
Astroglide X Silicone Personal Lubricant	K210242	FDA 510(k)	Class II	Active
Astroglide Sensual Strawberry	K140590	FDA 510(k)	Class II	Active
Glycerin & Paraben Free Astroglide	K072647	FDA 510(k)	Class II	Active
Astroglide Ultra Gentle Gel	K220355	FDA 510(k)	Class II	Active
Astroglide Organix Liquid	K200114	FDA 510(k)	Class II	Active
Astroglide Diamond Silicone Gel Personal Lubricant	K163395	FDA 510(k)	Class II	Active
Astroglide Sensual Strawberry Personal Lubricant	K213671	FDA 510(k)	Class II	Active
Astroglide Glycerin & Paraben Free	K220653	FDA 510(k)	Class II	Active
Astroglide Natural	K141581	FDA 510(k)	Class II	Active
Astroglide Warming	K221036	FDA 510(k)	Class II	Active
Good Lubrications	K020586	FDA 510(k)	Class I	Active
Astroglide	K935299	FDA 510(k)	Class I	Active
Astroglide Brand Warming Liquid Personal Lubricant	K041432	FDA 510(k)	Class II	Active

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