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 the complexities of FDA regulations for medical device companies, particularly those seeking to market their products in the United States.
**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 encompass regulatory strategy, quality systems, FDA submissions (including 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, such as the De Novo pathway and the Safer Technologies Program (STeP).
* Offers support for medical device inventors and companies, from those new to FDA regulations to established departments needing additional assistance.
**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.
* Kenneth L. Block holds the Regulatory Affairs Certification (RAC) from RAPS.
* Offices located in Richardson, Texas (US Headquarters), Paris (Europe Office), and Tokyo (Japan Office).
* Authored original content presented in published articles, given invited speeches at medtech events, and participated in conference panel sessions.
* 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. The company specializes in navigating the complexities of FDA regulations for medical device companies, particularly those seeking to market their products in the United States.
**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 encompass regulatory strategy, quality systems, FDA submissions (including 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, such as the De Novo pathway and the Safer Technologies Program (STeP).
* Offers support for medical device inventors and companies, from those new to FDA regulations to established departments needing additional assistance.
**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.
* Kenneth L. Block holds the Regulatory Affairs Certification (RAC) from RAPS.
* Offices located in Richardson, Texas (US Headquarters), Paris (Europe Office), and Tokyo (Japan Office).
* Authored original content presented in published articles, given invited speeches at medtech events, and participated in conference panel sessions.
* 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 navigating the US FDA regulatory landscape. They offer specialized services such as FDA establishment registration and device listing, crucial for foreign manufacturers. The firm's expertise extends to various FDA submission types, including 510(k), PMA, De Novo, and Pre-Submissions, as well as the STeP program for innovative devices. Their global presence with offices in the US, Europe, and Japan facilitates international client support. Clients can expect a structured approach to regulatory compliance, aiming to empower them with the knowledge and confidence to succeed in the US market.
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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Kenneth L. Block holds the Regulatory Affairs Certification (RAC).
Source
“He has also earned the Regulatory Affairs Certification (RAC) from the Regulatory Affairs Professionals Society (RAPS).”
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Global presence with offices in the US, Europe (Paris), and Japan (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.”
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Specializes in 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.”
Certifications & Trust Signals
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Established presence since 2005.
Source
“In 2005, Ken Block Consulting (KBC) began as the one-person venture of Kenneth L. Block...”
-
Kenneth L. Block holds the Regulatory Affairs Certification (RAC).
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 US FDA market access
- Companies needing assistance with FDA establishment registration and device listing
- Manufacturers requiring support for complex FDA submissions (510(k), PMA, De Novo)
How engagement typically works
- Consultative approach to regulatory strategy
- Direct interaction with FDA personnel
- Focus on client empowerment and knowledge transfer
Typical deliverables
- FDA Establishment Registration and Device Listing
- Regulatory Strategy Development
- FDA Submission Dossiers (510(k), PMA, De Novo)
- Quality System Compliance Guidance
- Audit and Inspection Support
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 mentions that specific documentation, record keeping, submissions, and assignments are required by FDA regulations, and that Ken Block Consulting has expertise in implementing compliance mechanisms.
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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