Ken Block Consulting (US Agent / Official Correspondent)
Office of Foreign Assets Control
Medical device regulatory consulting firm offering FDA US Agent services for foreign companies, establishment registration, device listings, compliance strategy, quality systems and regulatory submissions.
Ken Block Consulting (KBC) specializes in FDA regulatory and consulting services for medical device companies. They offer US Agent and Official Correspondent services for foreign medical device establishments, facilitating communication between the FDA and foreign entities. Services include FDA registration and listing, 510(k)/PMA/De Novo submissions, quality systems design, validation, inspection readiness, and regulatory strategy. KBC assists with addressing inquiries regarding devices imported into the United States and helps schedule FDA inspections.
About
**Who they are**
Ken Block Consulting (US Agent / Official Correspondent) is a medical device regulatory consulting firm established in 2005. The company specializes in navigating FDA regulations for medical device companies, offering expertise in regulatory affairs, quality systems, and submissions.
**Expertise & scope**
* Expertise in FDA regulatory compliance, including detailed knowledge of requirements and implementation of compliance mechanisms.
* Direct experience interacting with FDA personnel during inspections, submission reviews, and meetings.
* Services include regulatory strategy, quality systems, FDA submissions (e.g., 510(k), PMA, De Novo), registration and listing, audits and inspections, validation, compliance and remediation, and risk management.
* Specialized knowledge of pathways such as the De Novo pathway and the Safer Technologies Program (STeP).
* Support for foreign companies requiring FDA US Agent services.
**Reputation / proof points**
* Founded in 2005 by Kenneth L. Block, who has over 35 years of experience in FDA-regulated medical device and laser product technologies and holds the Regulatory Affairs Certification (RAC).
* Operates with offices in the US (Richardson, Texas), Tokyo, and Paris, serving as global hubs.
* Authored original content, given invited speeches at medtech events, and participated in conference panel sessions.
* Work has been referenced in law school citations and industry article references.
Ken Block Consulting (US Agent / Official Correspondent) is a medical device regulatory consulting firm established in 2005. The company specializes in navigating FDA regulations for medical device companies, offering expertise in regulatory affairs, quality systems, and submissions.
**Expertise & scope**
* Expertise in FDA regulatory compliance, including detailed knowledge of requirements and implementation of compliance mechanisms.
* Direct experience interacting with FDA personnel during inspections, submission reviews, and meetings.
* Services include regulatory strategy, quality systems, FDA submissions (e.g., 510(k), PMA, De Novo), registration and listing, audits and inspections, validation, compliance and remediation, and risk management.
* Specialized knowledge of pathways such as the De Novo pathway and the Safer Technologies Program (STeP).
* Support for foreign companies requiring FDA US Agent services.
**Reputation / proof points**
* Founded in 2005 by Kenneth L. Block, who has over 35 years of experience in FDA-regulated medical device and laser product technologies and holds the Regulatory Affairs Certification (RAC).
* Operates with offices in the US (Richardson, Texas), Tokyo, and Paris, serving as global hubs.
* Authored original content, given invited speeches at medtech events, and participated in conference panel sessions.
* Work has been referenced in law school citations and industry article references.
Additional information
Ken Block Consulting provides comprehensive support for medical device companies navigating the complexities of FDA regulations. Their services are designed for both new entrants to FDA regulations and established companies needing additional assistance. They emphasize a client-centric approach, focusing on building trust, showing respect, and delivering success. The firm is committed to protecting client confidentiality and providing honest, transparent information to empower clients in their interactions with regulatory authorities. They offer specialized assistance for foreign manufacturers needing a US Agent, ensuring compliance with establishment registration and device listing requirements.
Key Highlights
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Founded in 2005, with over 35 years of founder experience in FDA-regulated medical device technologies.
Source
“In 2005, Ken Block Consulting (KBC) began as the one-person venture of Kenneth L. Block, whose background includes an undergraduate science degree in physics and more than 35 years of experience in FDA-regulated medical device and laser product technologies.”
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Offers specialized support for foreign companies needing FDA US Agent services and establishment registration.
Source
“Ken Block Consulting offers a variety of services to address the needs of medical device inventors and companies, both those that are new to FDA regulations and those that have established regulatory affairs departments in need of additional assistance.”
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Provides expertise on various FDA submission pathways, including De Novo and STeP.
Source
“The De Novo pathway for device marketing rights was added to address novel devices of low to moderate risk that do not have a valid predicate device.”
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Maintains a global presence with offices in the US, Paris, and Tokyo.
Source
“In 2009, an office in Tokyo was added as a hub for clients throughout Asia, along with the formation of Ken Block Consulting LLP in Japan (subsequently incorporated as Ken Block Consulting Co., Ltd. in 2017). In 2018, Ken Block Consulting France SAS was formed as a regional hub for clients throughout Europe, with an office established in Paris.”
Certifications & Trust Signals
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Founder holds Regulatory Affairs Certification (RAC) from RAPS.
Source
“He has also earned the Regulatory Affairs Certification (RAC) from the Regulatory Affairs Professionals Society (RAPS).”
Buyer Snapshot
Best for
- Foreign medical device companies seeking FDA US Agent services
- Companies new to FDA regulations
- Established companies needing specialized regulatory support
How engagement typically works
- Client-centric approach
- Focus on trust and transparency
- Empowering clients with knowledge
Typical deliverables
- FDA US Agent representation
- Establishment registration and device listing
- Regulatory strategy development
- FDA submission preparation and support
- Quality system consulting
- Compliance and remediation guidance
Good to know
- Best when requiring specialized FDA regulatory expertise for medical devices.
HQ:
Richardson, US
Languages:
English
Timezones:
America/New_York, America/Chicago, America/Denver, America/Los_Angeles
Claim status:
Listed
Services & Capabilities
Best FDA US Agent Services | Compare & Get Quotes
Jurisdictions:
US
Countries:
US
Industries:
Medical devices, IVD
Portfolio:
1-5
Onboarding time:
1–10 days
Pricing model:
Custom pricing
Starting from:
USD 299
Included services:
FDA communications handling, Inspection scheduling coordination, Registration support, Annual renewal reminders
Product Type:
devices, food, drugs
Service Types:
US Agent Services, FDA Registration/Listing Support, Inspection Support, FDA Submissions (510(k), PMA, IDE, etc.), Product/Device Listing, Regulatory Consulting
Emergency Contact24x7:
No
Additional us_agent_fda Details
Included Services Detailed
Designation support and onboarding checklist for foreign establishment U.S. Agent setup, FDA communications receipt, acknowledgment, and routing to your designated contacts, Inspection scheduling support and operational readiness escalation (when applicable), Annual registration renewal reminders and administrative coordination
Excluded Services
Acting as importer of record, Commercial distribution management, Legal representation in enforcement actions
Onboarding Steps
The website content does not detail specific onboarding steps, required documents, timelines, or setup processes.
Coverage Details
U.S.-based agent coverage with defined business-hours availability and escalation path (seed summary).
Product Types
Medical Devices
Registration Support
Yes
Recall Support
Yes
Inspection Support
Yes
Emergency Contact24x7
No
US Entity State
Texas
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