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 by Kenneth L. Block. The company specializes in helping medical device companies navigate FDA regulations.
**Expertise & scope**
* Expertise in FDA regulatory compliance, including detailed knowledge of requirements and implementation.
* Direct experience interacting with FDA personnel during inspections, submission reviews, and meetings.
* Services include regulatory strategy, quality systems, FDA submissions (510(k), PMA, De Novo, Pre-Subs), registration and listing, audits and inspections, validation, compliance and remediation, and risk management.
* Specialized knowledge in pathways for novel devices, including the De Novo pathway and the Safer Technologies Program (STeP).
* Offers assistance to companies new to FDA regulations as well as those with established regulatory affairs departments.
**Reputation / proof points**
* Founded in 2005.
* Has offices in the US (Richardson, Texas), Tokyo, Japan, and Paris, France.
* Mr. Block has over 35 years of experience in FDA-regulated medical device and laser product technologies and holds the Regulatory Affairs Certification (RAC).
* The company has authored content, given speeches at medtech events, and participated in panel sessions worldwide.
* KBC 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 by Kenneth L. Block. The company specializes in helping medical device companies navigate FDA regulations.
**Expertise & scope**
* Expertise in FDA regulatory compliance, including detailed knowledge of requirements and implementation.
* Direct experience interacting with FDA personnel during inspections, submission reviews, and meetings.
* Services include regulatory strategy, quality systems, FDA submissions (510(k), PMA, De Novo, Pre-Subs), registration and listing, audits and inspections, validation, compliance and remediation, and risk management.
* Specialized knowledge in pathways for novel devices, including the De Novo pathway and the Safer Technologies Program (STeP).
* Offers assistance to companies new to FDA regulations as well as those with established regulatory affairs departments.
**Reputation / proof points**
* Founded in 2005.
* Has offices in the US (Richardson, Texas), Tokyo, Japan, and Paris, France.
* Mr. Block has over 35 years of experience in FDA-regulated medical device and laser product technologies and holds the Regulatory Affairs Certification (RAC).
* The company has authored content, given speeches at medtech events, and participated in panel sessions worldwide.
* KBC work has been referenced in law school citations and industry article references.
Additional information
Ken Block Consulting provides comprehensive support for medical device companies seeking to market their products in the United States. Their services extend to assisting with complex FDA submissions, including pathways for novel devices like De Novo and STeP. The firm emphasizes building client knowledge and confidence for future regulatory interactions. They operate with a policy of ethics and transparency, prioritizing client confidentiality and delivering accurate information. Engagement typically involves direct consultation to address specific regulatory challenges and strategic planning for market access.
Key Highlights
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Founded in 2005, with over 35 years of 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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Global presence with offices in the US, Japan, and France.
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.”
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Specializes in navigating complex 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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Offers direct interaction experience with FDA personnel for inspections and reviews.
Source
“Ken Block Consulting has a high level of expertise in FDA regulatory compliance, in both detailed knowledge of requirements and implementation of compliance mechanisms. We also have direct experience interacting with FDA personnel during inspections, submission reviews, and meetings.”
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).”
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Company work has been referenced in law school citations and industry article references.
Source
“KBC work has even been referenced by others as both law school citations and industry article references.”
Buyer Snapshot
Best for
- Foreign medical device companies seeking FDA US Agent services.
- Companies navigating complex FDA submission pathways (510(k), PMA, De Novo, STeP).
- Medical device manufacturers needing assistance with establishment registration and device listing.
How engagement typically works
- Direct consultation and strategic planning.
- Collaborative approach to build client knowledge.
- Emphasis on ethics, transparency, and client confidentiality.
Typical deliverables
- FDA US Agent representation.
- Regulatory strategy development.
- FDA submission preparation and support.
- Establishment registration and device listing.
- Quality system guidance.
- Audit and inspection preparation.
Good to know
- Best when requiring specialized expertise in US FDA medical device regulations.
- Suitable for companies needing support with novel device pathways.
HQ:
Richardson, US
Languages:
English
Timezones:
America/New_York, America/Chicago, America/Denver, America/Los_Angeles
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
Service Types:
US Agent Services, FDA Registration/Listing Support, Inspection Support, FDA Submissions (510(k), PMA, IDE, etc.), Product/Device Listing, Regulatory Consulting
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 provided content does not detail specific onboarding steps, required documents, or timelines.
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
