Resources for Providers and Practice Staff
Plain-language references to help your team understand the products we carry. These resources are educational and don't replace the manufacturer IFU or your own clinical, coding or billing judgment.
510(k) devices vs. HCT/Ps
510(k) Devices
510(k) devices are medical devices cleared through the FDA's 510(k) pathway. They are described by their cleared intended use. In our portfolio, the wound-care devices and the wound-cleansing ultrasound system are cleared through the FDA's 510(k) pathway.
HCT/Ps
HCT/Ps are human cells, tissues and cellular and tissue-based products regulated under 21 CFR Part 1271. Those regulated solely under Section 361 of the Public Health Service Act need no premarket review. For the amniotic products we carry, the manufacturer IFUs describe use as a barrier and protective covering.
Regulatory Distinction
The two categories are regulated differently, and we describe each product only within its own category.
Plain-language references to help your team understand the products we carry. These resources are educational and don't replace the manufacturer IFU or your own clinical, coding or billing judgment.
​
510(k) devices vs. HCT/Ps
​
510(k) Devices
510(k) devices are medical devices cleared through the FDA's 510(k) pathway. They are described by their cleared intended use. In our portfolio, the wound-care devices and the wound-cleansing ultrasound system are cleared through the FDA's 510(k) pathway.
​
HCT/Ps
HCT/Ps are human cells, tissues and cellular and tissue-based products regulated under 21 CFR Part 1271. Those regulated solely under Section 361 of the Public Health Service Act need no premarket review. For the amniotic products we carry, the manufacturer IFUs describe use as a barrier and protective covering.
​
Regulatory Distinction
The two categories are regulated differently, and we describe each product only within its own category.
Medical Glossary
Exudate
Fluid that drains from a wound.
Debridement
Removing dead or unhealthy tissue so the wound bed can be treated.
Maintenance Debridement
Removal of material such as fibrin, yellow slough, tissue exudates and bacteria from the wound (term used in the manufacturer's indications for use).
Secondary Dressing
The dressing placed over the product; usually not included in the box.
Homologous Use
The repair, reconstruction, replacement, or supplementation of a recipient's cells or tissues with an HCT/P that performs the same basic function or functions in the recipient as in the donor (21 CFR 1271.3(c)). NextGen does not determine regulatory status or whether a use qualifies; see the manufacturer's labeling.
HCT/P
Human cells, tissues, and cellular and tissue-based products (21 CFR Part 1271).
510(k)
The FDA premarket clearance pathway for medical devices.
Manufacturer traceability records
Some manufacturers require your practice to complete a traceability record for each unit used. Follow the manufacturer's instructions for completing and returning it.
Manufacturer IFUs
We send the manufacturer's labeling (IFU or product sheet) on request for products we supply.
Coding Basics
We don't publish product codes on this site. Codes change quarterly, and the right code depends on the exact product, setting and payer. Coding and billing are the provider's responsibility; coverage varies by payer.
Articles
Industry and regulatory updates from our team.
Exudate
Fluid that drains from a wound.
​
Debridement
Removing dead or unhealthy tissue so the wound bed can be treated.
​
Maintenance Debridement
Removal of material such as fibrin, yellow slough, tissue exudates and bacteria from the wound (term used in the manufacturer's indications for use).
​
Secondary Dressing
The dressing placed over the product; usually not included in the box.
​
Homologous Use
The repair, reconstruction, replacement, or supplementation of a recipient's cells or tissues with an HCT/P that performs the same basic function or functions in the recipient as in the donor (21 CFR 1271.3(c)). NextGen does not determine regulatory status or whether a use qualifies; see the manufacturer's labeling.
​
HCT/P
Human cells, tissues, and cellular and tissue-based products (21 CFR Part 1271).
​
510(k)
The FDA premarket clearance pathway for medical devices.
​
Manufacturer traceability records
Some manufacturers require your practice to complete a traceability record for each unit used. Follow the manufacturer's instructions for completing and returning it.
​
Manufacturer IFUs
We send the manufacturer's labeling (IFU or product sheet) on request for products we supply.
​
Coding Basics
We don't publish product codes on this site. Codes change quarterly, and the right code depends on the exact product, setting and payer. Coding and billing are the provider's responsibility; coverage varies by payer.
​
Articles
Industry and regulatory updates from our team.
Provider Tools
Plain-language references to help your team understand the products we carry. These resources are educational and don't replace the manufacturer IFU or your own clinical, coding or billing judgment.
Request an IFU
We send the manufacturer's labeling (IFU or product sheet) on request for products we supply. Manufacturer labeling lists the indications and, where provided, contraindications, warnings and precautions.
