US FDA 510(k) Regulatory Support

Prepare Your Medical Device for the U.S. Market

A 510(k) Premarket Notification is used to demonstrate that a medical device intended for the U.S. market is substantially equivalent to a legally marketed predicate device, where a 510(k) is required. FDA evaluates the submission to determine whether the device can be cleared for commercial distribution.

Medsure Consulting supports manufacturers in understanding the applicable FDA pathway and preparing the regulatory documentation required for a 510(k) submission.

Our approach focuses on regulatory strategy, appropriate predicate identification, evidence development, documentation, and submission readiness.

Our US FDA 510(k) Services

Comprehensive 510(k) Submission Support

01 — Regulatory & Device Assessment

We begin by understanding your device and determining the applicable U.S. regulatory pathway.

Support includes:

• Device assessment

• Intended-use assessment

• Device classification

• Product code identification

• Applicable FDA requirements

• 510(k) pathway assessment

02 — Predicate Device Identification

Predicate selection is a critical component of a 510(k) submission.

FDA requires the submitter to compare the subject device with one or more legally marketed predicate devices when establishing substantial equivalence.

Medsure supports:

• Predicate device research

• Predicate comparison

• Intended-use comparison

• Technological-characteristics comparison

• Identification of relevant differences

• Substantial-equivalence strategy

03 — Substantial Equivalence Strategy

A 510(k) must establish substantial equivalence between the subject device and an appropriate predicate.

Medsure Consulting supports the development of the regulatory argument around:Subject Device, Predicate Device, Intended Use, Technological Characteristics, Differences, Safety & Effectiveness, Substantial Equivalence

FDA notes that substantial equivalence does not require devices to be identical; differences must be evaluated to determine whether they raise different questions of safety and effectiveness.

04 — 510(k) Technical Documentation

We support the preparation and organization of the documentation required for the submission.

Depending on the device and applicable pathway, this may include:

• Device description

• Indications for use

• Predicate comparison

• Substantial equivalence discussion

• Performance testing

• Biocompatibility information

• Electrical safety and EMC information, where applicable

• Software documentation, where applicable

• Sterilization information, where applicable

• Labelling

• Clinical information, where applicable

05 — 510(k) Submission Preparation

Medsure supports the preparation and review of the 510(k) submission package before FDA submission.

This includes:

• Submission structure

• Documentation review

• Consistency checks

• Evidence review

• Regulatory gap identification

• Submission readiness review

• eSTAR preparation support

FDA currently requires most 510(k) submissions to be submitted electronically using eSTAR, subject to applicable exemptions.

06 — FDA Review Support

After submission, FDA may communicate with the submitter during the review process.

Medsure can support the regulatory response process by helping:

• Review FDA questions

• Coordinate technical responses

• Identify required supporting documentation

• Prepare response documentation

• Maintain consistency with the original submission

US FDA 510(k) Process

From Device Assessment to FDA Clearance

01 — Assess

Understand the device, intended use and regulatory requirements.

04 — Prepare Documentation

Compile technical, performance, testing, labelling, and regulatory documentation..

05 — Submit

Prepare and submit the applicable 510(k) package to FDA.

06 —Respond & Review

Support regulatory communication and responses during FDA review.

02 — Classify

Identify the applicable FDA classification and product code.

03 — Identify Predicate

Research and evaluate appropriate legally marketed predicate devices.

Frequently asked questions

What is CE Marking under EU MDR 2017/745?

CE Marking for medical devices demonstrates that the device has undergone the applicable conformity assessment process and meets the relevant requirements of EU MDR 2017/745.

Does every medical device require a Notified Body?

Not every device follows the same conformity assessment route. The requirement for Notified Body involvement depends on the applicable regulatory pathway and device classification.

How is a medical device classified under EU MDR?

Classification is determined using the classification rules established under EU MDR 2017/745, considering factors such as intended purpose and the characteristics of the device.

What documents are required for CE Marking?

The documentation depends on the device and its regulatory pathway. It can include technical documentation, GSPR documentation, risk management, clinical evaluation, verification and validation evidence, labelling, IFU, and other applicable records.

How long does CE Marking take?

The timeframe varies depending on the device, classification, documentation readiness, testing requirements, conformity assessment route, and whether Notified Body assessment is required.

Can Medsure review existing EU MDR documentation?

Yes. Existing documentation can be reviewed to identify regulatory gaps, inconsistencies, missing evidence, and areas requiring further development.

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