FDA Regulatory Consulting — Frequently Asked Questions

Question 1

What does an FDA medical device consultant do?

Accepted Answer

An FDA medical device consultant guides companies through the U.S. regulatory process required to legally market a medical device. This includes determining the correct device classification, identifying the right premarket submission pathway (such as a 510(k), De Novo, or PMA), preparing and submitting regulatory filings to the FDA, and helping companies establish and maintain a Quality Management System (QMS) that meets FDA requirements under the Quality Management System Regulation (QMSR, 21 CFR Part 820). Consultants also assist with FDA establishment registration, device listing, labeling review, adverse event reporting (MDR), and preparation for FDA inspections. For foreign manufacturers, a consultant may serve as or arrange a U.S. Agent — a regulatory requirement for all non-U.S. device manufacturers selling into the American market.

Question 2

When do I need to file a 510(k) with the FDA?

Accepted Answer

A 510(k) premarket notification is required when you want to market a Class II medical device in the United States and your device has not received a previous FDA exemption. The 510(k) process demonstrates that your device is substantially equivalent to a legally marketed predicate device already on the U.S. market. You will need a new 510(k) if you are introducing a new medical device to the U.S. market for the first time, making a significant change to an already-cleared device that could affect safety or effectiveness, or are a foreign manufacturer seeking FDA clearance to sell in the U.S. The standard 510(k) FDA user fee for fiscal year 2026 is $26,067, or $6,517 for qualifying small businesses.

Question 3

What is the difference between a 510(k), De Novo, and PMA?

Accepted Answer

These are three distinct FDA premarket submission pathways for medical devices. A 510(k) (Premarket Notification) is used for Class II moderate-risk devices and requires demonstrating substantial equivalence to a predicate device — it is the most common pathway, with FDA review typically taking 3 to 6 months. A De Novo Classification Request is used when a novel, low-to-moderate risk device has no predicate, and the 2026 FDA fee is $173,782 ($43,446 for small businesses). A PMA (Premarket Approval) is used for Class III highest-risk devices such as implantable pacemakers or coronary stents, requires clinical evidence of safety and effectiveness, and carries a 2026 standard fee of $579,272 ($144,818 for small businesses). Choosing the wrong pathway wastes significant time and money.

Question 4

Do foreign medical device manufacturers need a U.S. Agent?

Accepted Answer

Yes. The FDA requires all foreign establishments that manufacture medical devices, drugs, or biological products intended for the U.S. market to designate a U.S. Agent. This is a regulatory requirement under 21 CFR Part 807 and is not optional. A U.S. Agent must reside or maintain a place of business in the United States, be available to the FDA during business hours, assist with communications between the FDA and the foreign manufacturer, and help facilitate FDA inspections when required. Failure to designate a U.S. Agent can result in import alerts, rejection of shipments, or device listing refusal. MDI Consultants serves as U.S. Agent for numerous foreign medical device manufacturers.

Question 5

What is CE marking, and do I need it to sell medical devices in Europe?

Accepted Answer

CE marking is mandatory for medical devices sold in the European Union and several other European countries including the UK, Norway, Switzerland, and Turkey. Medical devices in Europe are regulated under the MDR (EU 2017/745) for most medical devices and the IVDR (EU 2017/746) for in vitro diagnostic devices. The CE marking process involves a conformity assessment, technical documentation preparation, clinical evaluation, and for Class IIa, IIb, and Class III devices, review by a Notified Body. FDA clearance and CE marking are separate processes with different requirements, and most companies entering global markets must pursue both. MDI Consultants has helped over 100 companies achieve CE marking and has experience with both the MDR and IVDR pathways.

Question 6

What is ISO 13485, and why does my medical device company need it?

Accepted Answer

ISO 13485 is the international standard for Quality Management Systems specific to the medical device industry. Certification to ISO 13485 is required or strongly preferred by most international markets including the EU (it supports CE marking compliance) and Canada (Health Canada requires it for Class II through IV devices). It is also aligned with FDA QMS requirements, as the FDA's Quality Management System Regulation (QMSR) is harmonized with ISO 13485:2016. ISO 13485 certification signals to regulators, customers, and partners that your company has consistent processes for producing safe, effective devices. MDI Consultants has a 100% first-time certification success rate for clients who follow their ISO preparation process.

Question 7

How long does FDA 510(k) clearance take?

Accepted Answer

The FDA's official target review time for a standard 510(k) is 90 days from the date the submission is accepted as filed. However, total time from submission to clearance is typically 4 to 9 months for a well-prepared submission. The FDA often issues Additional Information (AI) requests during review, and responding quickly is critical to avoiding delays. Scheduling a Q-submission (pre-Sub) meeting with the FDA before filing can identify issues early and significantly shorten total time. The most common causes of 510(k) delays are insufficient predicate device justification, incomplete clinical or performance testing data, and labeling deficiencies.

Question 8

What happens during an FDA inspection of a medical device facility?

Accepted Answer

An FDA inspection of a medical device facility (formally called a Quality System Inspection Technique, or QSIT inspection) is an official audit of your manufacturing facility and quality management system. Investigators evaluate compliance with 21 CFR Part 820 (the QMSR). They typically review design controls and design history files (DHF), Device Master Records (DMR) and Device History Records (DHR), CAPA processes, complaint handling and MDR procedures, production and process controls, and supplier controls. If investigators identify deficiencies, they issue a Form 483 at the close of the inspection. A Warning Letter may follow unresolved 483 issues. MDI Consultants provides on-site inspection support and 483 response services.

Question 9

What is MDSAP, and is it required?

Accepted Answer

MDSAP (Medical Device Single Audit Program) allows a single regulatory audit of a medical device manufacturer to satisfy the requirements of multiple participating regulatory authorities simultaneously. Current MDSAP participating countries include the United States (FDA), Canada (Health Canada), Brazil (ANVISA), Australia (TGA), and Japan (MHLW). MDSAP is mandatory in Canada — Health Canada requires MDSAP certification for most Class II, III, and IV medical device license applications. It is also accepted by the FDA as an alternative to routine FDA facility inspections. An MDSAP audit is conducted by an Authorized Auditing Organization (AAO) and covers quality system requirements across all participating jurisdictions in a single visit.

Question 10

How much does FDA medical device consulting cost?

Accepted Answer

FDA consulting costs vary depending on the scope and complexity of the project. Common pricing models include hourly rates (typically $200 to $400 per hour for experienced regulatory consultants), fixed-fee project pricing for defined deliverables such as a 510(k) submission or ISO 13485 preparation, and retainer arrangements for ongoing compliance support. MDI Consultants operates on a fixed-price model — clients receive a defined project scope and a set total cost before work begins. If a project takes longer than planned, MDI absorbs the risk, not the client. MDI also offers a performance guarantee: clients who follow MDI's process are guaranteed 510(k) clearance or first-time ISO certification. For a no-obligation consultation and fee estimate, contact MDI Consultants at info@mdiconsultants.com or 516-482-9001.

FDA Medical Device Consulting — Frequently Asked Questions

1. What does an FDA medical device consultant do?

2. When do I need to file a 510(k) with the FDA?

You will need a new 510(k) if you:

3. What is the difference between a 510(k), De Novo, and PMA?

510(k) (Premarket Notification):

De Novo Classification Request:

PMA (Premarket Approval):

4. Do foreign medical device manufacturers need a U.S. Agent?

A U.S. Agent must:

5. What is CE marking, and do I need it to sell medical devices in Europe?

Medical devices in Europe are regulated under:

6. What is ISO 13485, and why does my medical device company need it?

Certification to ISO 13485 is

7. How long does FDA 510(k) clearance take?

8. What happens during an FDA inspection of a medical device facility?

During an inspection, FDA investigators typically review:

9. What is MDSAP, and is it required?

MDSAP is:

10. How much does FDA medical device consulting cost?

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