Approval of medical devices in the USA - A guide for manufacturers
The USA is the largest market for medical devices worldwide. Manufacturers who wish to sell their products in the USA must meet the strict regulatory requirements of the U.S. Food and Drug Administration (FDA). The approval process differs fundamentally from the European regulations and requires different testing and approval processes depending on the risk class.
This guide provides a detailed overview of the requirements for entering the US market.
General overview of the medical device market in the USA
Population size
The USA has a population of around 332 million people (as of 2024), making it the third largest market in the world.
Market volume
- With a volume of over 200 billion US dollars, the US market for medical technology is the largest in the world.
- The market accounts for around 40 percent of global sales of medical products.
- The USA imports a large proportion of its medical technology products, particularly from the EU, China and Mexico.
Forecasts for the next three years
- The US market for medical devices is expected to grow at a compound annual growth rate (CAGR) of 5 to 6 percent.
- Key growth drivers are innovative medical technologies, artificial intelligence (AI) and the digitalization of the healthcare industry.
- The regulatory landscape is evolving to integrate new technologies and market requirements.
Competent authority for medical devices in the USA
The U.S. Food and Drug Administration (FDA) is the authority responsible for regulating medical devices in the USA.
Tasks of the FDA
- Approval and classification of medical devices
- Monitoring of clinical trials
- Market surveillance and enforcement of safety requirements
- Control of manufacturing practices and inspections according to 21 CFR Part 820
- Carrying out recalls and risk assessments
Official source of information
Further information on the regulation of medical devices in the USA can be found on the official website of the FDA:
FDA - Center for Devices and Radiological Health (CDRH)
Legal requirements in the USA
Legal basis for medical devices
The most important legal bases for medical devices in the USA are
- Federal Food, Drug, and Cosmetic Act (FDCA)
- 21 CFR Part 820 - Quality System Regulation (QSR)
- 21 CFR Part 11 - Electronic records and signatures
- 21 CFR Part 50 & 56 - Clinical trials and ethical standards
Among other things, these regulations govern the requirements for product approval, quality assurance and clinical safety of medical devices.
Differences to the EU MDR
- The US requires FDA approval or clearance prior to market entry, while the EU requires CE marking.
- The regulatory requirements are based on FDA classifications, not on the EU MDR risk classification.
- The FDA conducts manufacturer inspections to ensure that companies comply with quality management system requirements.
Information on the need for a local representative
Is a local representative required to approve or register medical devices?
Yes, foreign manufacturers must designate a U.S. Agent to register their products in the U.S.
Requirements for the U.S. Agent
- The U.S. agent must be a legal entity domiciled in the USA.
- He is responsible for communication with the FDA, especially in the event of recalls or regulatory inquiries.
- It does not assume any legal responsibility for product conformity, but acts as a point of contact for the FDA.
Manufacturers based in the U.S. do not need a U.S. Agent, but must meet all FDA regulatory requirements.
Definition and classification of medical devices
According to which law is this determined in the USA?
Medical devices are classified in accordance with the Federal Food, Drug, and Cosmetic Act (FDCA) and the FDA regulations in 21 CFR Part 860.
Classification of medical devices according to FDA
The FDA divides medical devices into three risk classes:
- Class I - Low risk (e.g. dressings, surgical scissors)
- Class II - Medium risk (e.g. infusion pumps, ultrasound devices)
- Class III - High risk (e.g. pacemakers, artificial joints)
The FDA has an extensive database for medical device classifications in which manufacturers can research the classification of their products.
Approval process for medical devices in the USA
What approval procedures are there?
The FDA offers three main routes to medical device approval:
- 510(k) clearance (for Class I and II devices)
- Manufacturers must prove that their product is similar to an already approved product (predicate device).
- No clinical studies required if there are no new risks.
- Average processing time: 3 to 6 months
- Premarket Approval (PMA) (for Class III products)
- Requires clinical studies on safety and efficacy.
- Very complex procedure, comparable to drug approval.
- Average processing time: 12 to 24 months
- De Novo process (for innovative products without a predicate device)
- For new technologies without comparable predecessors.
- Average processing time: 6 to 12 months
Average duration of approval procedures
- 510(k) procedure: 3 to 6 months
- Premarket Approval (PMA): 12 to 24 months
- De Novo procedure: 6 to 12 months
Costs incurred
The FDA charges processing fees for approval procedures, which change annually. The following fees apply for 2024:
- 510(k) application: approx. 19,000 USD
- Premarket Approval (PMA): approx. 450,000 USD
- De Novo application: approx. 112,000 USD
Small companies can apply for discounts.
Validity of the registration or approval
- A 510(k) clearance or PMA approval is permanently valid as long as no significant changes are made to the product.
- Manufacturers must renew their FDA Establishment Registration annually.
Language requirement
- All documents must be submitted in English.
- Instructions for use and product labeling must contain FDA-compliant content.
Conclusion
The approval of medical devices in the USA requires careful planning and compliance with strict regulatory requirements.
Important points summarized:
- U.S. Agent is mandatory for foreign manufacturers.
- 510(k), PMA and De Novo procedures are the main approval routes.
- FDA inspections and quality requirements are stricter than in the EU.
- English is the official language for all submissions.
Support from MEDAGENT
MEDAGENT offers comprehensive services for FDA approval:
- Assumption of the function as U.S. Agent
- Advice and support for 510(k) and PMA procedures
- Quality management according to FDA standards
- Communication with the FDA to optimize the approval process
For more information or assistance with FDA approval, contact us directly.
