Regulating medical device combination productsare assigned to a FDA center that will have primary jurisdiction for its premarket review and regulation. To resolve these types of questions, FDA’s regulations at 21 CFR Part 3 include an algorithm for determining center assignment.Combination products should not be confused with Fixed-Combination Drugs (FCDs), which are drug-drug combinations.
Regulating medical device combination productsby FDA, there must be two or more regulated components, (i.e., drug/device, biologic/device, drug/biologic, or drug/device/biologic) that are physically, chemically, or otherwise combined or mixed and produced as a single entity, or two separate products that are packaged together and per proposed labeling are intended for use together to achieve a desired effect.
- Operon Strategist assists companies and medical device manufacturers by providing consultancy services that support theregistration of Combination Products.
Combination product for Medical Device
We have experience with each constituent part and the GMP regulations that together form the basis for their development and manufacture.
Contact Us WhatsAppIf the product consists of a device drug combination or a biologic drug combination or a biologic device combination then it is considered to be a combination product. A few everyday examples are dental floss with fluoride, inhalers, nasal-spray pumps and first aid kits.
A product is not considered to be a combination product if it only incorporates two products from the same category. For example, a drug combination is not considered a combination product, even though it may be considered combination therapy in the clinical world.
Regulating medical device combination productsby FDA that determines the appropriate category that a combination product belongs to by using regulatory pathways. One category is for medical devices (CDRH), one is for drugs (CDER) and one is for biologics (CBER). However, combination products don’t fit perfectly into just one of these categories.
The category that the combination product belongs to is determined by deciding the most important way that the product accomplishes what it’s intended for. This category or application type also determines what requirements apply to the product.
How to regulating medical device combination products
Combination products are assigned to a FDA center that will have primary jurisdiction for its premarket review and regulation. Consistent with section 503(g)(1) of the Act, assignment to a center with primary jurisdiction for premarket review and post-market regulation, or a lead center, is based on a determination of the “primary mode of action” (PMOA) of the combination product.
For example, if the PMOA of a device-biological combination product is attributable to the biological product, the Agency component responsible for premarket review of that biological product would have primary jurisdiction for the combination product.
Some Examples of FDA Combination Products?
Examples of combination products include pre-filled syringes, insulin injector pens, metered dose inhalers, transversal patches, drug eluting stents, and catheters with antimicrobial coatings, infusion pumps, medicated wound treatments and therapeutic orthopedic implants.The pipeline of combination products promises unprecedented drug delivery innovations. Integration of smart phone apps, global positioning technology and smart features built into devices and packaging are on the way.
快速寻找创新的combination products found a tattoo-like skin patch for diabetes sufferers that can detect glucose levels in its wearer’s sweat and accordingly will deliver a drug as needed.Regulating medical device combination products asof this writing, innovations such as these are increasing in prevalence with growing consumer expectations related to ease of use, less restrictive living and integration with smart technologies.
Regulating medical device combination productswas cleared under a 510(k), it only needs to comply with medical device regulations pending the details in the FDA product clearance letter. Always revisit the details of the FDA clearance to check for any additional ‘drug-related’ controls.
To further support the position that theRegulating medical device combination productsis considered/regulated as a medical device, consider providing links to a few representative product records currently published. The CDRH related database includes medical device identifiers and attributes and demonstrates reporting of this product as a medical device.
As would be expected, each of the Centers has access to personnel and expertise associated with its assigned regulated products. In the case ofRegulating medical device combination products, this organization within a single Center is not sufficient to address all of the legal, regulatory, and scientific concerns. The issues associated with combination products cross the regulatory and scientific boundaries between Centers. In order to address the types of complex issues associated with combination products.