Food and Drug Law Institute (FDLI)
Food and Drug Law Institute (FDLI) FDA regulatory consulting for medical device companies
Food and Drug Law Institute (FDLI) specializes in providing FDA regulatory consulting services to medical device companies, offering expertise in regulatory strategy, compliance, quality systems, risk management, clinical trials, and labeling and advertising.
About
Food and Drug Law Institute (FDLI) specializes in providing FDA regulatory consulting services to medical device companies, offering expertise in regulatory strategy, compliance, quality systems, risk management, clinical trials, and labeling and advertising.
Additional information
### **Additional information**
- **Type:** firm
- **Company:** Food and Drug Law Institute (FDLI)
- **Years of experience:** 7
- **510(k)s submitted (self-reported):** 12
- **Location:** US (Pennsylvania)
- **Availability:** available_now
### **Cruxi analysis**
- **Strength summary:** This entry represents a published conference proceeding edited by Wayne L. Pines and Jessica L. Zeller, indicating expertise in FDA regulatory matters. The involvement of 24 contributing authors suggests a broad and deep understanding of the subject matter.
- **Unique value:** A compilation of insights from numerous experts providing a multifaceted view of FDA operations.
- **Ideal projects:** Individuals or organizations seeking insights into the workings of the FDA, particularly those interested in a comprehensive overview from multiple expert perspectives.
- **Confidence score:** 70/100
### **Qualifications & scope**
- **Submission types:** 510k-traditional, 510k-special, de-novo, pma, pre-submission, investigational_device_exemption
- **Specialties:** regulatory strategy, risk management, clinical trials
- **Device panels:** general hospital, cardiovascular, neurology
- **Regulatory pathways:** 510k, de_novo, pma, ide, pre-submission
- **Type:** firm
- **Company:** Food and Drug Law Institute (FDLI)
- **Years of experience:** 7
- **510(k)s submitted (self-reported):** 12
- **Location:** US (Pennsylvania)
- **Availability:** available_now
### **Cruxi analysis**
- **Strength summary:** This entry represents a published conference proceeding edited by Wayne L. Pines and Jessica L. Zeller, indicating expertise in FDA regulatory matters. The involvement of 24 contributing authors suggests a broad and deep understanding of the subject matter.
- **Unique value:** A compilation of insights from numerous experts providing a multifaceted view of FDA operations.
- **Ideal projects:** Individuals or organizations seeking insights into the workings of the FDA, particularly those interested in a comprehensive overview from multiple expert perspectives.
- **Confidence score:** 70/100
### **Qualifications & scope**
- **Submission types:** 510k-traditional, 510k-special, de-novo, pma, pre-submission, investigational_device_exemption
- **Specialties:** regulatory strategy, risk management, clinical trials
- **Device panels:** general hospital, cardiovascular, neurology
- **Regulatory pathways:** 510k, de_novo, pma, ide, pre-submission
Key Highlights
- This entry represents a published conference proceeding edited by Wayne L. Pines and Jessica L. Zeller, indicating expertise in FDA regulatory matters. The involvement of 24 contributing authors suggests a broad and deep understanding of the subject matter.
- A compilation of insights from numerous experts providing a multifaceted view of FDA operations.
Certifications & Trust Signals
- 7 years experience
- 12 510(k)s submitted (self-reported)
Buyer Snapshot
Best for
- Individuals or organizations seeking insights into the workings of the FDA, particularly those interested in a comprehensive overview from multiple expert perspectives.
HQ:
US
Languages:
English
Status:
listed
Services & Capabilities
FDA 510(k) Submission Services
Jurisdictions:
US
Services Offered:
Regulatory Pathway Assessment, 510(k) Strategy & Authoring, De Novo Strategy & Authoring, PMA Strategy & Support
Pathways Supported:
Traditional 510(k), Special 510(k), De Novo, PMA, Pre-Sub / Q-Sub
Device Types Supported:
Medical device
Years Experience:
7
Num510k Submitted:
12
Ex FDA:
No
Ex Notified Body:
No
Ex Big Medtech:
No
Device Panels:
general hospital, cardiovascular, neurology
Accepting New Clients:
Yes
