FAQ
FREQUENTLY ASKED QUESTIONS
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General Questions
When you're bringing a new medical device to market, there are a few regulatory pathways to consider. First, there's the 510(k) submission, which is the most common route. You'd use this if your device is pretty similar to something that's already FDA-approved—what they call a 'predicate' device.
If there's nothing out there quite like your device, but it’s still low to moderate risk, you’d go with a De Novo classification request. That’s for newer technologies that don’t quite fit into existing categories but don’t need the most intense review either.
Then there's Premarket Approval (PMA)—this one’s the most thorough (and toughest). It’s for high-risk, Class III devices, and you’ll need solid clinical trial data to show that your device is both safe and effective.
The FDA classifies devices into three categories based on risk:
- Class I – Low risk, subject to general controls (e.g., bandages, toothbrushes). Most do not require premarket submission, but often require registration and will open the manufacturer to FDA audits.
- Class II – Moderate risk, typically requires a 510(k) submission (e.g., infusion pumps, powered wheelchairs), followed by routine FDA audits
- Class III – High risk, requiring PMA submission with clinical data (e.g., pacemakers, artificial heart valves), followed by routine FDA audits.
Search the FDA Product Classification Database or consult 21 CFR Parts 862-892 to determine classification.
FDA submissions require:
- Predicate Decision - Comparison of the subject device and predicate device required for 510(k) submissions
- Safety & Efficacy Testing – Includes biocompatibility, electrical safety, and software validation if applicable.
- Risk Assessment – Conducted under ISO 14971 to ensure hazards are mitigated.
- Clinical Data – Required for Class III (PMA) and sometimes Class II devices.
- Labeling & Instructions for Use – Must comply with FDA labeling regulations.
- Quality System Compliance – The device must be manufactured under 21 CFR Part 820 (Quality System Regulation, QSR).
The timeline for FDA review varies depending on the type of submission:
510(k) Review typically takes between 90 and 180 days, although it can take longer if the FDA requests additional data.
De Novo Review generally requires 6 to 12 months or longer, as it involves a more in-depth classification process.
PMA Approval often takes 12 to 24 months, factoring in the time needed for clinical trials and FDA inspections.
Breakthrough Device Designation is designed to expedite the review process for innovative technologies that address serious or life-threatening conditions.
Adverse Event Reporting – It's essential to comply with Medical Device Reporting requirements outlined in 21 CFR Part 803. Any adverse events involving your device must be reported promptly and accurately.
Corrective and Preventive Actions (CAPA) – Any identified defects or safety concerns must be thoroughly investigated, reported, and addressed through a documented CAPA process to ensure ongoing product safety and compliance.
Annual Reports and Inspections – Devices approved under a Premarket Approval (PMA) are required to submit annual reports and remain prepared for routine FDA inspections to maintain regulatory compliance.
UDI Compliance – All applicable devices must be labeled with a Unique Device Identifier (UDI) to support traceability, facilitate recalls, and enhance post-market surveillance.
510(k) FDA Compliance Submissions Questions
eSTAR is an interactive, standardized template designed to help medical device manufacturers submit regulatory applications electronically. Unlike traditional PDF-based submissions, eSTAR:
- Uses pre-formatted sections to ensure all required information is included.
- Features built-in validation checks to reduce deficiencies and prevent missing data.
- Improves FDA review efficiency, leading to faster processing times compared to manual submissions.
As of October 1, 2023, eSTAR is mandatory for all 510(k) and De Novo submissions, with PMAs also adopting the format.
The eSTAR system currently supports:
- 510(k) Submissions (Traditional, Special, and Abbreviated) – Mandatory
- De Novo Requests – Mandatory
- Premarket Approval (PMA) – Recommended
eSTAR does not apply to Humanitarian Device Exemptions (HDEs) or Biologics License Applications (BLAs).
FDA review times vary by submission type:
- 510(k) Submissions – Typically 90 days, but may be faster due to fewer deficiencies and improved formatting in eSTAR.
- De Novo Requests – Can take 120–150 days, depending on device complexity.
- PMA Submissions – Typically 6–12 months, but eSTAR may help reduce review cycles.
Although eSTAR streamlines the process, FDA may still issue Requests for Additional Information (AIQs) if data is unclear or incomplete.
Medical Device Labeling Questions
Medical device labeling must comply with FDA regulations (21 CFR Part 801) in the U.S. and EU MDR requirements in Europe. Generally, labeling must include:
- Device name and model
- Intended use and indications
- Manufacturer's name and address
- Instructions for use (IFU)
- Warnings, precautions, and contraindications
- Unique Device Identification (UDI) for traceability
Each country has specific formatting, language, and content requirements, making compliance essential.
Yes, many countries require labels to be translated into their official languages. For example:
- EU MDR mandates multilingual labeling based on target countries.
- Canada requires English and French labels.
- Latin American markets like Mexico, Peru, and Colombia require Spanish translations.
Failure to comply with local language requirements can result in regulatory rejections or delays.
Symbols are commonly used to replace text-based information for universal understanding and space efficiency. Medical device labeling must comply with:
- ISO 15223-1 (Standard for medical device symbols).
- IEC 60601-1 (For electrical medical devices).
- EU MDR & FDA guidelines on standardized symbols.
Using incorrect symbols or failing to provide a symbol glossary in the IFU can lead to compliance issues.
Labeling compliance doesn’t end at product launch. Regulatory agencies require ongoing updates and surveillance, including:
- Labeling revisions for safety updates, recalls, or regulatory changes.
- UDI data maintenance in global databases.
- Periodic audits to ensure continued compliance.
- Changes in manufacturing locations or distribution that may affect labeling requirements.
Companies must monitor global regulatory updates to ensure labeling remains accurate and compliant.
UDI Implementation Questions
A UDI consists of two main parts:
- Device Identifier (DI): A mandatory, fixed portion of the UDI that identifies the manufacturer and specific version/model of the device.
- Production Identifier (PI): A variable component that may include lot/batch number, serial number, expiration date, or manufacturing date.
The UDI must be encoded in both human-readable and machine-readable formats (barcode or RFID) and comply with a government-approved issuing agency, such as:
- GS1 (Global Standard)
- HIBCC (Health Industry Business Communications Council)
- ICCBBA (For Blood & Biologic Devices)
UDI requirements differ across regulatory bodies:
- FDA (U.S.) – UDI must be submitted to the Global Unique Device Identification Database (GUDID) for all Class II and III devices (and some Class I).
- EU MDR (Europe) – UDI compliance is mandatory for EUDAMED, with stricter data submission and post-market tracking.
- China (NMPA) – Requires localized UDI submission and a China-specific UDI database.
- Other Markets (Japan, Brazil, Canada, etc.) – Have varying adoption timelines and database structures.
Understanding regional variations is critical to ensuring global compliance and avoiding market-entry delays.
The choice of a UDI issuing agency depends on the device type and industry preferences:
- GS1 – The most commonly used system, suitable for most general medical devices and widely recognized worldwide.
- HIBCC – Often preferred for hospital-based devices with custom serialization needs.
- ICCBBA – Required for biologic and blood-related products.
Manufacturers should align their choice with regulatory requirements and existing supply chain standards to ensure smooth integration.
EU MDR International Regulations Questions
Each region has its own regulatory structure:
- FDA (USA) – Devices are classified into Class I, II, or III and typically require a 510(k), De Novo, or PMA submission. Compliance with 21 CFR Part 820 (Quality System Regulation) is mandatory.
- EU MDR (Europe) – Devices are classified as Class I, IIa, IIb, or III with stricter clinical evidence requirements than before. Manufacturers must work with a Notified Body for higher-risk devices.
- Other Regions (Mexico, Canada, Latin America, Asia, etc.) – Each country has its own classification and submission process. Some recognize FDA and EU approvals to fast-track certain device registrations.
Understanding these differences is critical to aligning your strategy, avoiding delays, and minimizing redundant work when filing in multiple markets.
Yes, many countries require a Local Authorized Representative (LAR) or in-country regulatory agent. Examples include:
- European Union (EU MDR) – Requires an Authorized Representative (EC REP) for non-EU manufacturers.
- Mexico (COFEPRIS) – Requires a local registrant who holds the Sanitary Registration.
- Peru (DIGEMID) & Colombia (INVIMA) – Require a Local Authorized Representative for foreign manufacturers.
- China (NMPA) – Requires a China Agent to manage regulatory filings and post-market surveillance.
Selecting the right local representative is crucial, as they handle communications with regulatory agencies, submit documentation, and ensure post-market compliance.
While document requirements vary, most international submissions require:
- Technical File / Device Master File – Includes device description, intended use, and technical specifications.
- Risk Management Report – Must comply with ISO 14971 (Risk Management for Medical Devices).
- Clinical Data / Performance Studies – Required for higher-risk devices in the EU, China, and Canada.
- Quality System Certification – Many countries require compliance with ISO 13485 (Medical Device QMS) or FDA’s 21 CFR Part 820.
- Labeling & Instructions for Use (IFU) – Must align with local language and regulatory requirements.
- Proof of Regulatory Approval (if applicable) – Some countries accept FDA or EU MDR approvals as part of their review process.
Ensuring all documents meet country-specific formatting and translation requirements can prevent unnecessary delays.
Approval timelines vary significantly depending on the country and device classification:
- USA (FDA 510(k)) – ~90–180 days; PMA can take 1–2 years.
- EU MDR (Notified Body Review) – 6–18 months for Class II and III devices.
- Mexico (COFEPRIS) – 4–8 months, but can take longer for high-risk devices.
- Canada (Health Canada Licensing) – Class II-IV devices take 3–12 months.
- China (NMPA) – 12–24 months, with potential local clinical trials required.
- Brazil (ANVISA) – 6–18 months, requiring compliance with Good Manufacturing Practices (GMP).
Many factors influence these timelines, including review backlogs, additional data requests, and the need for in-country clinical trials.
A strategic regulatory approach can help reduce redundancy and speed up approvals:
- Leverage Existing Approvals – Some countries recognize FDA 510(k) or EU MDR approvals, allowing for expedited registration.
- Harmonize Technical Documentation – Maintain a core regulatory dossier that can be adapted for different markets.
- Plan for Labeling & Language Requirements Early – Many countries require localized labeling and translated documents, which should be prepared in advance.
- Work with Local Experts – Engage regulatory consultants and in-country representatives who understand the nuances of local requirements.
- Stay Updated on Regulatory Changes – Countries frequently revise regulations, so ongoing compliance monitoring is essential.
By having a global regulatory strategy, companies can reduce submission time, prevent rework, and expand internationally with greater efficiency.
Support Tailored To Your Regulatory & Innovation Goals
Whether you need assistance with a Class I registration, FDA audit, 510(k) submission support, De Novo, PMA, EU MDR, or international regulatory navigation, Isaac Erickson offers tailored consulting services to help you achieve your goals efficiently and effectively. Let’s turn your vision into a fully compliant, market-ready success.