United States market

FDA regulatory services, from strategy to market authorisation.

HSC manages your device's entire regulatory pathway in the United States: classification, submission pathway selection, quality system, evidence and post-market support, with technical expertise from start to finish.

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Regulatory coverage

The entire FDA regulatory cycle with one partner

The US market requires a methodical approach: the right submission pathway, correct classification, an inspection-ready quality system and consistent technical evidence. HSC structures every stage, from initial strategy to authorisation and post-market support, for domestic and international manufacturers.

See also the UDI implementation required by GUDID and the overview of FDA registration in the United States.

Service scope

Comprehensive scope, service by service

01

FDA regulatory strategy

  • Defining the regulatory strategy for entering or expanding in the United States market.
  • Assessing the product's regulatory status and defining the most appropriate pathway.
  • Identifying the applicable regulatory pathway: 510(k), De Novo, PMA, 513(g), 510(k) Exempt.
  • Developing a regulatory roadmap covering stages, risks, required documents and upcoming decision milestones.
  • Assessing regulatory risks that may affect timelines, investment, commercial launch or continued market access.
  • Supporting decisions on portfolio priorities, product development and submission strategy.
02

FDA classification of medical devices

  • Determining the device's FDA classification: Class I, Class II or Class III.
  • Identifying the applicable regulation number in 21 CFR.
  • Identifying the FDA product code.
  • Assessing whether a 510(k) submission is required or an exemption applies.
  • Mapping applicable special controls and standards.
  • Analysing similar devices already authorised by the FDA to support the regulatory strategy.
03

Predicate device research and substantial equivalence

  • Structured research into predicate devices and reference devices.
  • Comparative analysis of the client's device and the reference devices identified.
  • Assessing substantial equivalence in terms of intended use, indications for use, technological characteristics, materials, design, performance, biocompatibility, sterilisation, shelf life and software, where applicable.
  • Developing a comparative matrix of the predicate and subject devices.
  • Technical justification for selecting the most appropriate predicate device.
  • Identifying gaps that may undermine the substantial equivalence argument.
04

510(k) submission

  • Planning and structuring the 510(k) submission.
  • Preparing a Traditional 510(k), Special 510(k) or Abbreviated 510(k), as applicable.
  • Preparing or reviewing the 510(k) Summary or 510(k) Statement.
  • Preparing the Indications for Use Statement.
  • Organising the submission package in a format consistent with FDA expectations.
  • Reviewing completeness against the Refuse to Accept (RTA) Checklist.
  • Supporting the use of eSTAR, where applicable.
  • Assisting with responses to FDA Additional Information Requests.
  • Providing technical and regulatory support throughout the review cycle until the FDA's final decision.
05

De Novo submission

  • Assessing eligibility for the De Novo pathway.
  • Developing the regulatory strategy for innovative devices without a suitable predicate device.
  • Identifying risks and defining mitigations.
  • Proposing special controls to support classification of the new device type.
  • Preparing or reviewing the De Novo submission package.
  • Supporting the preparation of clinical and non-clinical evidence.
  • Assisting with FDA interactions and responses to requests.
06

PMA (Premarket Approval)

  • Assessing whether PMA is required for Class III devices.
  • Regulatory planning for PMA submissions.
  • Gap assessment of technical, clinical, quality and manufacturing documentation.
  • Organising the PMA technical package.
  • Supporting the preparation of clinical and non-clinical evidence.
  • Supporting manufacturing, design, labelling and clinical data modules.
  • Supporting responses to deficiency letters.
  • Supporting PMA Supplements, where applicable.
07

513(g) Request for Information

  • Assessing the strategic value of submitting a 513(g) Request for Information.
  • Preparing a technical briefing to seek advice on classification, product code or applicable requirements.
  • Preparing the 513(g) request.
  • Defining clear, focused regulatory questions for the FDA.
  • Analysing the FDA's response and explaining its implications for regulatory and commercial strategy.
08

Pre-Submission / Q-Submission Program

  • Planning early engagement with the FDA through the Q-Submission Program.
  • Preparing the Pre-Submission package.
  • Preparing strategic questions to reduce regulatory uncertainty before the main submission.
  • Defining the agenda, briefing document and supporting materials.
  • Preparing the team for its FDA meeting.
  • Analysing the minutes, comments and recommendations received.
  • Updating the regulatory strategy based on FDA feedback.
09

Establishment Registration and Device Listing

  • Assessing the need for FDA establishment registration.
  • Supporting FDA Establishment Registration.
  • Supporting Device Listing.
  • Providing guidance on US Agents for foreign manufacturers.
  • Supporting the creation or update of an Owner/Operator Account.
  • Assisting with annual registration updates.
  • Checking public regulatory status in FDA databases.
10

Small Business Determination, MDUFA User Fees and Cover Sheet

  • Assessing eligibility for FDA Small Business Determination.
  • Providing guidance on the documentation required for US companies and foreign manufacturers seeking Small Business status.
  • Supporting the preparation and review of the Small Business Certification Request, where applicable.
  • Providing guidance on Medical Device User Fee Amendments (MDUFA) and fees applicable to submissions such as 510(k), De Novo and PMA.
  • Assisting with the generation, review and organisation of the Medical Device User Fee Cover Sheet.
  • Providing guidance on user fee payment, identification of the Payment Identification Number (PIN) and correct allocation of the fee to the submission.
  • Checking consistency between the submission type, MDUFA fee, Cover Sheet and regulatory package.
  • Helping prevent administrative delays relating to fees, forms or inconsistencies in the submission process.
11

FDA labelling requirements

  • Reviewing labelling against 21 CFR Part 801.
  • Reviewing Instructions for Use (IFU).
  • Reviewing labels, packaging labels and carton labels.
  • Assessing intended use and indications for use.
  • Checking regulatory and promotional claims.
  • Assessing contraindications, warnings, precautions and adverse events.
  • Reviewing Unique Device Identification (UDI) requirements.
  • Reviewing labelling for sterile, reusable, implantable or software-containing devices.
  • Reviewing electronic labelling, where applicable.
12

UDI (Unique Device Identification)

  • Assessing the applicability of UDI requirements.
  • Defining the UDI strategy for the product, packaging and commercial distribution levels.
  • Supporting the structuring of the Device Identifier (DI) and Production Identifier (PI).
  • Providing guidance on FDA-recognised issuing agencies.
  • Supporting data preparation for the Global Unique Device Identification Database (GUDID).
  • Reviewing labelling in relation to the UDI carrier.
  • Assessing applicable deadlines, exceptions and specific requirements.
13

FDA quality system

  • Gap assessment against 21 CFR Part 820 (Quality System Regulation).
  • Gap assessment against the FDA Quality Management System Regulation (QMSR), aligned with ISO 13485.
  • Assessing readiness for FDA inspection.
  • Reviewing critical quality system procedures: design controls, purchasing controls, production and process controls, CAPA, complaint handling, document control, records, training, management responsibility and internal audits.
  • Assessing the Design History File (DHF), Device Master Record (DMR) and Device History Record (DHR).
  • Supporting quality system adaptation for the US market.
14

Design controls

  • Assessing compliance with FDA design controls.
  • Reviewing the design and development plan, user needs, design inputs and design outputs.
  • Reviewing design verification and design validation.
  • Reviewing design transfer, design changes and design review records.
  • Organising or performing a gap assessment of the Design History File (DHF).
  • Supporting integration between product development, risk management, usability, software and performance evidence.
15

Risk management

  • Reviewing the risk management file.
  • Assessing alignment with ISO 14971.
  • Mapping regulatory and technical risks.
  • Reviewing hazard analysis and risk control measures.
  • Assessing the benefit-risk rationale.
  • Integrating risk management, labelling, usability, clinical evaluation and post-market surveillance.
  • Supporting the risk matrix for FDA submission.
16

Performance testing and non-clinical evidence

  • Defining the testing strategy for FDA submission.
  • Gap assessment of performance testing.
  • Reviewing test protocols and reports.
  • Assessing bench testing, mechanical testing, electrical safety and electromagnetic compatibility (EMC), where applicable.
  • Assessing sterilisation validation, packaging validation, shelf life, ageing studies and transportation testing.
  • Assessing cleaning, disinfection and reprocessing validation for reusable devices.
  • Identifying additional evidence required to substantiate safety, performance and substantial equivalence.
17

Biocompatibility

  • Assessing biocompatibility requirements against ISO 10993 and FDA guidance.
  • Defining the biological evaluation plan.
  • Reviewing the biological evaluation report.
  • Gap assessment of biological testing.
  • Assessing the type, duration and nature of body contact.
  • Justifying the use of literature, material history or biological equivalence.
  • Reviewing chemical characterisation and toxicological risk assessment, where applicable.
18

Sterilisation, packaging and shelf life

  • Assessing the sterilisation strategy.
  • Reviewing sterilisation validation for ethylene oxide (EO), radiation, steam or aseptic processing, where applicable.
  • Reviewing packaging validation.
  • Reviewing stability and shelf-life studies.
  • Assessing the sterile barrier system.
  • Reviewing residuals, bioburden, endotoxin and sterility assurance level (SAL), where applicable.
  • Assessing labelling requirements for sterile products.
19

Software as a Medical Device (SaMD) and embedded software

  • Regulatory assessment of medical software, including SaMD and embedded software.
  • FDA classification and strategy for medical software.
  • Gap assessment against applicable FDA guidance.
  • Reviewing software documentation for submission.
  • Assessing software level of concern, where applicable.
  • Reviewing software requirements specification, architecture design chart, hazard analysis and verification and validation testing.
  • Assessing cybersecurity requirements and change control.
  • Developing a strategy for AI/ML-enabled medical devices, where applicable.
20

Cybersecurity

  • Cybersecurity gap assessment for FDA submission.
  • Reviewing threat modelling and cybersecurity risk assessment.
  • Assessing the Software Bill of Materials (SBOM).
  • Reviewing the security maintenance and update plan.
  • Assessing vulnerability management.
  • Reviewing cybersecurity-related labelling requirements.
  • Supporting responses to FDA questions on cybersecurity.
21

Usability and human factors

  • Assessing the applicability of human factors engineering.
  • Reviewing the usability engineering file.
  • Reviewing use-related risk analysis and critical tasks.
  • Reviewing formative studies and the human factors validation study.
  • Reviewing the IFU and user interface from a safe-use perspective.
  • Gap assessment against FDA expectations for human factors.
22

Clinical evidence

  • Assessing the need for clinical data for FDA submission.
  • Gap assessment of existing clinical evidence.
  • Reviewing the clinical evaluation strategy for the US market.
  • Reviewing clinical literature.
  • Assessing clinical investigation requirements.
  • Providing regulatory support for an Investigational Device Exemption (IDE), where applicable.
  • Reviewing clinical study protocols and reports.
  • Supporting justification for the absence of a clinical study, where technically defensible.
23

FDA post-market support

  • Assessing post-market obligations.
  • Supporting the establishment of complaint handling processes.
  • Assessing Medical Device Reporting (MDR), 21 CFR Part 803.
  • Supporting Corrections and Removals, 21 CFR Part 806.
  • Assessing recall strategy.
  • Reviewing periodic reports, where applicable.
  • Supporting the analysis of adverse events and field safety actions.
  • Assessing post-approval studies, where applicable.
24

Importation and commercialisation in the USA

  • Assessing requirements for importing medical devices.
  • Supporting the definition of responsibilities between the manufacturer, importer, distributor and US Agent.
  • Reviewing documentation for product entry into the United States.
  • Assessing the risk of an import hold or detention.
  • Providing regulatory support relating to the FDA import process.
  • Reviewing commercial claims and promotional materials for the US market.
25

FDA regulatory due diligence

  • Regulatory due diligence for acquisitions, investments or partnerships.
  • Documentary assessment of a medical device portfolio.
  • Checking FDA status: establishment registration, device listing, 510(k) clearance, De Novo authorization, PMA approval, recalls, warning letters and inspection history, where available.
  • Identifying regulatory gaps.
  • Assessing risks relating to commercialisation in the United States.
  • Reviewing technical and quality documentation.
  • Developing a regulatory risk matrix.
  • Providing technical support for investment, acquisition or strategic partnership decisions.
26

FDA inspection readiness

  • Assessing readiness for FDA inspection.
  • Mock inspection.
  • Reviewing the history of CAPA, complaints, nonconformities and design changes.
  • Training internal teams on the FDA inspection process.
  • Supporting preparation of responses to Form FDA 483.
  • Supporting responses to a Warning Letter.
  • Post-inspection remediation plan.

Packages

Suggested engagement options

Package 01

FDA Regulatory Assessment

FDA classification, product code and regulation number, regulatory pathway assessment, preliminary predicate search, gap mapping and recommendations for next steps.

Package 02

FDA 510(k) Readiness

Predicate device analysis, gap assessment of technical and testing documentation, labelling review, RTA readiness assessment and an action plan for the 510(k) submission.

Package 03

FDA Submission Support

Preparation of 510(k), De Novo or PMA submissions, organisation of the technical package and regulatory sections, support with eSTAR, Cover Sheet and MDUFA, and responses to FDA questions.

Package 04

FDA Small Business & MDUFA Support

Small Business Determination eligibility, documentation guidance, Small Business Certification Request, MDUFA user fees and Cover Sheet, helping prevent administrative delays.

Package 05

FDA QMS Readiness

Gap assessment against 21 CFR Part 820 and QMSR, review of critical procedures, assessment of DHF, DMR and DHR, remediation planning and FDA inspection readiness.

Package 06

FDA Regulatory Due Diligence

Portfolio assessment, FDA regulatory status checks, submission and registration review, gap matrix and technical report for M&A, investment or partnership.

Services are tailored to the device type, FDA class, regulatory pathway, development stage, quality system maturity and the client's commercial objective.

Why HSC?

End-to-end regulatory expertise

Certified MDSAP RTP

Recognised by Exemplar Global. Technical expertise supporting FDA projects.

Combined expertise in FDA, ANVISA, EU MDR and MDSAP

One partner to manage US registration consistently with other markets.

From gap analysis to post-market support

We cover the full cycle: strategy, submission, quality system, inspection and post-market obligations.

English-language support for international manufacturers

We support manufacturers outside the USA requiring a US Agent, registration and FDA submission.

Next step

Bring your device to the US market with a methodical approach

Speak to an HSC specialist for an initial assessment of your product's FDA regulatory pathway and gaps.

Speak to a specialist