This article has been updated May 29, 2025. The institution responsible for regulating medical devices in the United States is the Food and Drug Administration (FDA).
The medical device industry is one of the most heavily regulated sectors in the United States, with the Food and Drug Administration (FDA) overseeing every aspect from development to market distribution. The FDA’s Center for Devices and Radiological Health (CDRH) plays a pivotal role in this regulatory framework, ensuring that medical devices available to American consumers are safe and effective.
If you’re a manufacturer, developer, or distributor looking to enter the U.S. medical device market, understanding this complex regulatory landscape is crucial. This guide breaks down the essential components of FDA regulation, offering a clear roadmap to navigate the various pathways to market authorization.
Understanding Device Classification
The FDA categorizes medical devices into three classes based on risk level and the regulatory controls necessary to ensure safety and effectiveness:
Class I (Low Risk)
- Subject primarily to general controls
- Examples: elastic bandages, examination gloves, hand-held surgical instruments
- Most Class I devices are exempt from Premarket Notification (510(k))
- Represent the simplest devices with minimal potential harm to users
Class II (Moderate Risk)
- Subject to both general controls and special controls
- May include performance standards, post-market surveillance, and patient registries
- Examples: powered wheelchairs, infusion pumps, surgical drapes
- Most require Premarket Notification 510(k)
Class III (High Risk)
- The most stringent regulatory category
- Devices that support or sustain human life, prevent health impairment, or present potential unreasonable risk
- Examples: implantable pacemakers, breast implants
- Generally require Premarket Approval (PMA)
Premarket Approval (PMA): The Pathway for High-Risk Devices
When manufacturers develop Class III medical devices, they typically follow the Premarket Approval pathway—the FDA’s most rigorous review process.
When is PMA Required?
PMA is required for Class III devices, including those that:
- Support or sustain human life
- Prevent impairment of human health
- Present potential unreasonable risk of illness or injury
PMA Application Types
The FDA offers several methods for PMA submission:
- Traditional PMA: For devices that have completed clinical testing
- Modular PMA: For devices still in clinical testing, allowing submission of completed modules
- Product Development Protocol (PDP): For devices based on well-established technology
- Humanitarian Device Exemption (HDE): For devices treating rare diseases
The PMA Review Process
- Administrative Review: Initial assessment of application completeness (45 days)
- Filing Review: Evaluation of whether the application warrants substantive review
- Substantive Review: Comprehensive evaluation of safety and effectiveness data
- 100-Day Meeting: Optional opportunity to discuss review status
- FDA Decision: Final determination (approval, approvable with conditions, or not approvable)
Timeline for PMA Approval
The average PMA approval timeframe is approximately 243 days post-submission, though this has improved in recent years. Prior to 2010, the average wait was around 345 days.
510(k) Premarket Notification: The Path for Moderate-Risk Devices
The 510(k) pathway is less stringent than PMA and is typically used for Class II and some Class I devices that aren’t exempt.
Who Needs to Submit a 510(k)?
- Domestic manufacturers introducing devices to the U.S. market
- Specification developers introducing devices to the U.S. market
- Repackers or relabelers making significant changes to devices
- Foreign manufacturers/exporters or their U.S. representatives
When is a 510(k) Required?
A 510(k) is necessary when:
- Introducing a device to the market for the first time
- Making significant changes to a legally marketed device that could affect safety or effectiveness
Types of 510(k) Submissions
- Traditional 510(k): For new devices or changes that don’t qualify for Special 510(k)
- Abbreviated 510(k): When relying on FDA guidance, special controls, or voluntary standards
- Special 510(k): For modifications to a manufacturer’s own legally marketed device
The 510(k) Process
- Submission and Acknowledgment: FDA assigns a unique “K number” upon receipt
- Acceptance Review: Within 15 days, the FDA determines if the submission meets acceptance criteria
- Substantive Review: Comprehensive review with communication within 60 days
- Final Decision: FDA issues a determination of “substantially equivalent” (SE) or “not substantially equivalent” (NSE)
Timeline for 510(k) Clearance
The FDA aims to reach a decision on 95% of 510(k)s within 90 FDA days (excluding time when the submission is on hold).
De Novo Classification Request
For novel, low to moderate-risk devices without a predicate, the De Novo pathway offers an alternative route to market.
Two Options for De Novo Classification
- Option 1: For devices that received an NSE determination in response to a 510(k)
- Option 2: For devices with no legally marketed predicate, allowing direct De Novo submission
Devices successfully classified through the De Novo process may be marketed and used as predicates for future 510(k) submissions.
Device Registration and Listing Requirements
All establishments involved in producing and distributing medical devices for the U.S. market must register with the FDA and list their devices.
Registration Timeline
- Initial Registration: Within 30 days of beginning manufacturing activities
- Annual Registration: Between October 1 and December 31 each year
- Processing Time: Up to 90 days for the FDA to assign a registration number
Registration Fees
For Fiscal Year 2025:
- Annual establishment registration fee: $9,280
- This fee applies to all establishments required to register
- No waivers or reductions are available for small businesses
Other notable fees include $24,335 for a 510(k) submission ($6,084 for small businesses) and $540,783 for a PMA application ($135,196 for small businesses).
Quality Management System Requirements
The FDA’s Quality System Regulation (QSR) under 21 CFR Part 820 establishes requirements for manufacturers to follow. As of January 31, 2024, the FDA has issued a final rule amending the QSR to incorporate ISO 13485:2016, becoming the Quality Management System Regulation (QMSR) effective February 2, 2026.
Key Components of FDA QMS Requirements
- Management Responsibility: Establish quality policies and organizational structure
- Quality Planning: Develop quality plans for device design and manufacturing
- Design Controls: Control the design process from planning to validation
- Document Controls: Manage all quality system documentation
- Purchasing Controls: Ensure purchased products and services meet requirements
- Production and Process Controls: Ensure manufacturing processes produce conforming devices
- Corrective and Preventive Action (CAPA): Address and prevent quality issues
- Records: Maintain quality system, complaint, and device history records
Labeling Requirements
The FDA regulates medical device labeling under 21 CFR Part 801, specifying what information must appear on device labels.
Key Labeling Requirements
- Name and Place of Business: Manufacturer or distributor information
- Intended Use: Accurate representation of device purpose
- Adequate Directions for Use: Clear instructions for safe and effective use
- Symbols: May be used if accompanied by a glossary or part of recognized standards
- OTC Devices: Must have consumer-friendly labeling
- Sterilization Information: Proper indication of sterile or non-sterile status
Medical Device Reporting (MDR) Requirements
The FDA requires manufacturers, importers, and device user facilities to report adverse events and product problems through the Medical Device Reporting system.
Reporting Requirements
- Manufacturers: Report within 30 calendar days (or 5 working days for designated events)
- Importers: Report deaths and serious injuries to both FDA and manufacturer within 30 days
- User Facilities: Report deaths to FDA and manufacturer, serious injuries to manufacturer
Clinical Trial Requirements
The Investigational Device Exemption (IDE) allows testing of investigational devices in human subjects while ensuring protection of those subjects.
Types of Investigational Device Studies
- Significant Risk (SR): Devices presenting potential serious health risks, requiring comprehensive FDA review
- Non-Significant Risk (NSR): Devices with lower potential harm, requiring IRB approval but not direct FDA review
- Exempt Studies: Certain diagnostic studies that meet specific criteria
IDE Process Elements
- Comprehensive application with device description and investigational plan
- Robust clinical protocol with clear objectives and endpoint measurements
- Informed consent process ensuring participants understand risks and benefits
- Rigorous safety monitoring throughout the study
- Ongoing regulatory compliance and reporting
