Medical devices · United States
FDA 510(k) Clearance — Medical Device Premarket Notification Compliance
FDA 510(k) Clearance — Medical Device Premarket Notification is issued by US Food & Drug Administration (CDRH) and has applied since 1976-05-28. It applies to products sold in US. Below: what it covers, which products trigger it, the documents a supplier must provide, and how Complyra checks a product against it.
- Authority
- US Food & Drug Administration (CDRH)
- Jurisdiction
- United States
- Regions
- US
- Effective
- 1976-05-28
- Evidence renewal
- every 3650 days
- Official source
- https://www.fda.gov/medical-devices/premarket-submissions-selecting-and-preparing-correct-submission/premarket-notification-510k
What FDA 510(k) Clearance — Medical Device Premarket Notification covers
FDA 510(k) Clearance — Medical Device Premarket Notification is a medical devices requirement in United States. In Complyra's dataset it is triggered by products in the following categories and by product descriptions that mention the keywords listed below.
Product categories affected
Keywords that trigger a check
Who it applies to
Buyers importing or placing the affected products on the market in US, and the suppliers who manufacture or distribute them. In a procurement workflow the buyer is responsible for obtaining the evidence listed below from the supplier before the order is placed.
Consequences of non-compliance recorded in the dataset: FDA Warning Letter, Import Alert, injunction, criminal prosecution
Supplier requirements and compliance evidence
Documents a supplier should be able to provide for products in scope. Ask for these in the RFQ rather than after the goods ship.
| Document |
|---|
| 510(k) Clearance Letter from FDA |
| Substantial equivalence comparison to predicate |
| Performance testing data |
| Biocompatibility testing (ISO 10993) |
| Sterilization validation |
| Labelling per 21 CFR Part 801 |
Certification types recorded for this regulation
How Complyra checks FDA 510(k) Clearance — Medical Device Premarket Notification
When a product is searched or sourced in Complyra, its category and description are matched against the trigger categories and keywords above. If FDA 510(k) Clearance — Medical Device Premarket Notification applies, the product and its supplier are checked against the materials, substance limits and required documents recorded for the regulation, and the result is shown alongside the supplier match, before an RFQ is generated.
Suppliers on Complyra register and upload certifications that are reviewed by an administrator; see supplier compliance for how that review works and supplier sourcing for how compliant suppliers are found and matched.
Complyra checks product and supplier information against regulatory requirements to support procurement decisions. It does not issue certifications or guarantee legal compliance; final responsibility for compliance remains with the buyer and supplier.
Related regulations
- EU MDR 2017/745 — Medical Device Regulation
- ISO 13485:2016 — Medical Devices Quality Management System
- CE Marking — European Conformity Marking
- ISO 9001:2015 — Quality Management System
Industries where this regulation applies
- Medical devices and medical supplies — 5 regulations
More
- All regulations in the dataset
- Regulation index (all 47 in one table)
- Free compliance checker — which regulations apply to a product
- RFQ template generator — build a structured RFQ
- The full AI procurement workflow
Check a product against FDA 510(k) Clearance — Medical Device Premarket Notification
Describe the product and destination market. Complyra identifies whether this regulation applies and which documents to request from the supplier.