Proxima Resource Hub

How does FDA classify medical devices?

Approved, Granted or Cleared – which term for what pathway?

Is informed consent required when treating/diagnosing a patient with an HUD?

What statute and regulations apply to medical device clinical investigations?

What type of device studies do the IDE regulations (21 CFR 812) cover?

Does FDA require IRB review of off-label use of a legally marketed device?

Must an IRB review a study conducted after submission of 510(k) to FDA but prior to FDA’s decision on the submission?

What regulation describes custom devices?

Can a physician use an unapproved device in an emergency?

How are Medical Device Clinical Trials categorized?

How are Biopharma Clinical Trials categorized?

Explain the difference between Significant Risk (SR) vs. Non-Significant Risk (NSR) devices

Are IRBs Inspected by FDA?

What happens after the FDA inspects a clinical investigator?

What are some common deficiencies that have been observed by FDA investigators during a clinical investigator inspection?

When are IRB inspections conducted?

How are IRB inspections conducted?

What happens after an IRB inspection?

What may the FDA do until the IRB or parent institution takes appropriate corrective action?

What is an Exploratory IND approach?

What type of clinical information should be included in an IND submission?

When and why does the Form FDA 1572 need to be completed by an investigator?

When must a Form 1572 be updated or a new Form 1572 completed and signed by an investigator to reflect new or changed information?

Can a sponsor conduct a foreign clinical study under an IND, and if so, must investigators who conduct studies outside of the United States sign a 1572?

For foreign clinical studies conducted under an IND, how can an investigator sign the 1572 when the investigator knows he/she cannot commit to all of the requirements on the form, specifically IRB membership?

What are all the recommended sections of a Traditional or Abbreviated 510(k) submission?

What is the difference between Form FDA 3601, 3514, 3881, and 3454?

What information should be included in the 510(k) Cover Letter, 510(k) Summary, and 510(k) Statement?

What types of certifications and statements must be included in a 510(k) submission?

How do you determine substantial equivalence for a 510(k) submission?

How do 510(k) submissions review measures taken towards patient safety?

What is the difference between bench, animal, and clinical testing? Are all these forms of performance testing required?

What are some common reasons as to why a 510(k) submission would not be accepted?

What happens when the intended use of the proposed device is different from that of which appears on the labeling?

What is the special 510(k) program?

What should be included in a special 510(k) submission?

What is the abbreviated 510(k) program?

What should be included in an abbreviated 510(k) submission?

When performing a benefit-risk determination, what factors does the FDA consider?

What is the application process for breakthrough devices subject to PMA?

What is the application process for devices intended for small patient populations subject to PMA?

What is a De Novo request and when are they used?

What is included in a De Novo Pre-Sub?

What is the difference between acceptance review and substantive review during the review of a De Novo request?

What are the refuse to accept principles?

What happens if you submit your device for a 510(k) clearance, and it gets denied?

What happens if there is a pending 510(k) or PMA application for the same device with the same indications for use?

What information is required for a De Novo request?

Which regulations contain provisions relevant to in vitro diagnostic (IVD) devices?

How do you determine if an in vitro diagnostic (IVD) study is applicable for an IDE regulation?

How can you determine if an in vitro diagnostic (IVD) device is of significant risk?

What is the definition of a noninvasive device?

Are there different goals for IVD studies compared to other device studies?

What does the FDA consider to be valid scientific evidence?

Can you add additional testing on the same subject to the dataset, particularly when it is hard to find study subjects?

What factors should manufacturers consider in addressing cybersecurity?

What are the tiers for cybersecurity risk?

What is considered to be a “trustworthy device”?

What documentation should be included for Tier 1 and Tier 2 devices?

How can manufacturers identify and protect device assets and functionality?

What are the design expectations to help manufacturers detect, respond to, and recover cybersecurity risks?

What information should be included in the labeling regarding cybersecurity risks?

What information should be included in the risk management documentation in regards to cybersecurity risks?

What should be included in system diagrams, in regards to cybersecurity risks?

Under 21 CFR 312.8, who requests authorization from FDA to charge for an investigational drug for use under an IND?

When a sponsor uses its own investigational drug in a clinical trial, what requirements must the sponsor satisfy to charge for the drug?

What constitutes extraordinary cost?

If a sponsor’s own approved drug is used as concomitant therapy during a clinical trial intended to evaluate another drug, should the sponsor obtain authorization to charge for the drug used?

How can a sponsor charge for its investigational drug in a blinded, controlled clinical trial without compromising the blind and the integrity of the clinical data generated from the trial?

What requirements must a sponsor satisfy to charge for expanded access use?

How long may a sponsor charge for an investigational drug for expanded access use after FDA authorizes the charging?

What must a sponsor do to obtain authorization to continue charging for an investigational drug for expanded access use beyond the duration of its existing charging authorization?

What costs can a sponsor recover when charging for an investigational drug for expanded access use under 21 CFR part 312, subpart I?

Does a sponsor need FDA authorization to charge for the costs of drug delivery, formulation, packaging, instrumentation, monitoring, disposables, setup, and nursing care?

What information is a sponsor required to submit to support its cost calculation?

How are study subjects made aware of possible costs associated with participation?

What is the FDA’s policy regarding charging for investigational medical devices and radiological health products?

What is the FDA’s policy regarding charging for investigational drugs and biologics?

How is payment to research subjects for participation in studies viewed and assessed by IRBs?

Is it permitted to incentivize participants to complete the study by offering more money for completion?

What are the requirements if a physician decides to use a product for an indication not in the approved labeling when the intent is the practice of medicine?

Does clinical investigation of a marketed drug or biologic always require an IND submission?

Are research sponsors permitted to contact the Institutional Review Board (IRB) directly?

Are research sponsors obligated to determine IRB compliance with regulations?

Which party is responsible for maintaining and communicating confidential medical records and information during a study?

What role does the IRB play in determining the nonsignificant risk (NSR) status of a study?

What are the consequences of distributing unapproved IVDs labeled for research use only (RUO) or investigational use only (IUO)?

What regulation applies to research use only (RUO) or investigational use only (IUO) In Vitro Diagnostic (IVD) products?

What device investigations are subject to IDE regulation?

Are there activities that are prohibited by sponsors of an investigational device?

What device investigations are exempt from IDE regulation?

Do the FDA regulations permit non-local IRB review?

What documentation is needed to permit non-local IRB review?

How does the non-local IRB obtain knowledge of local community attitudes, conditions surrounding the conduct of the research, and the continuing status of the research?

What study materials must the IRB review?

What type of advertising must be reviewed by the IRB?

If a site uses a receptionist to screen subjects for studies, must the script he/she uses be reviewed by the IRB?

What is the Consent Process?

How should informed consent be documented?

What elements must be included in the Informed Consent Document?

Medical Device

510(k)

De Novo

Premarket Approval (PMA)

Predicate Device

Humanitarian Use Device (HUD)

Humanitarian Device Exemption (HDE)

ISO 13485

Medical Device Directive

European Union’s Medical Device Regulation (EUMDR)

21 CFR 820

21 CFR Part 11

Warning Letter

Good Laboratory Practice (GLP)

Serious Adverse Event (SAE)

Software as a Medical Device (SaMD)

Human Factors

Investigational Device Exemption (IDE)

Good Clinical Practice (GCP)

New Drug Application (NDA)

Investigational New Drug Application (IND)

Informed Consent Form (ICF)

Institutional Review Boards (IRB)

In Vitro Diagnostic (IVD)

Sunshine Act

21 CFR 812

Investigator

General Control

Special Control

Quality Management System

International Conference on Harmonization (ICH)

Exploratory IND

Abbreviated New Drug Application (ANDA)

Cooperative Research

Code of Federal Regulations (CFR)

FDA Form 483

Form FDA 1571

Form FDA 1572

Software as a Medical Device (SaMD) and Examples

CAPA (Corrective and Preventive Actions)

Medical Device Reporting (MDR)

2020 MTI LIVE Webinar 5: Clinical Trials & Studies - Pre-Approval to Post-Market

Safer Technologies Program (STeP) Breakdown

Global Medical Device Podcast: Understanding and Handling Different Types of Feedback

The Proxima Playbook: Understanding Your Biocompatibility Testing Requirements

Global Medical Device Podcast: What You Need to Know About Clinical Evaluation & Validation for Software as a Medical Device (SaMD)

Q2 Results Are In: Here are the Top Life Science Accelerators

Steps You Can Take to Answer If Your Product is A Drug or Medical Device

FDA Rollouts Innovation and Improvements to Medical Device Sterilization

Meet the Innovator: John Zellmer, MBA.

Global Medical Device Podcast: Addressing Clinical Trial Challenges & Concerns During Covid-19

Breakthrough Device Designation Reimbursement

Design Controls Digest: 5 Phases of Design Controls You Need to Know

"The Strategic Role of the Regulatory Professional", Regulatory Focus

Clinical Decision Support Software Guidance

Why Your CRO Should Be With You From Concept to Commercialization

Global Medical Device Podcast: Why SaMD Companies Should be Leveraging Pre-Submissions to FDA

2019 MTI LIVE Webinar 5: Gathering Evidence: Clinical Trial Development & Design

Global Medical Device Podcast: Preparing for EU MDR

Global Medical Device Podcast: 5 Tips for Hiring Medical Device Advisors

Global Medical Device Podcast: How to Establish a Solid Foundation for Fundraising and Product Success by Focusing on Regulatory

Global Medical Device Podcast: How to Integrate Usability into your Medical Device

Clinical Trials: Risky Business

Tackling ISO 10993-12 Biocompatibility

Global Medical Device Podcast: Comparing FDA's Breakthrough Devices Program & Safer Technologies Program

Greenlight Guru Webinar: Demystifying The Breakthrough Device Designation (BDD) & Safer Technologies (STeP) Processes

Top 3 Benefits of Breakthrough Device Designation or STeP Designation

Greenlight Guru Webinar: Company Essentials: The Benefits of a Well-Developed Regulatory Plan

Major Guidance Changes to Artificial Intelligence and Machine Learning

Isabella Schmitt: The Time is Now for Pediatric Device Development to be Centerstage

Kevin Coker: Top Five Considerations When Selecting a Contract Research Organisation

The Proxima Playbook: Who Wants to be a Wellness Device?

The 510(k) Program – All About This Submission Type

The Conception of Ideas | Inventing Tomorrow Podcast

Project MedTech: The Overlap of Regulatory Strategy And Business Strategy with Isabella Schmitt

What's So Special About The Special 510(k) Program?

All About About ASCA

Demystifying De Novo

M1 MedTech Accelerator Program Opens Applications to Early-Stage Medical Device Companies

The Top 3 Things You Need To Know About Cardiovascular Devices Under The FDA

Greenlight Guru Webinar: Is Regulation Necessary for Quality?

How AI (Artificial Intelligence) Dentistry is Transforming the Dental Device Industry

M1 MedTech Accelerator Program Announces First Cohort of Early-Stage Medical Device Companies

Greenlight Guru Webinar: Clinical Considerations for Software and Artificial Intelligence (AI) / Machine Learning (ML)

Navigating the Pre-Market Approval Application Process for Your Class III Medical Device

Biotech and MedTech Funding Series: Funding an Oncology Startup with CPRIT

510(k) or PMA: Should Your Medical Device Receive FDA Clearance or FDA Approval?

Expert Tips For Writing Your Clinical Trial Protocol

5 Key Strategies for Clinical Trial Patient Recruitment

A Patient-Centric Approach to Overcoming Patient Recruitment Challenges in Oncology

Why, When and How to Implement a Quality Management System (QMS)

Galen Data Webinar: Reducing AI Risk to Secure Regulatory Approval

Addressing Bias in AI for Medical Applications: A Comprehensive Guide

2023 And Me | The Proxima Post

FDA Issues Final Guidance: Device Software Functions and Premarket Submissions

Outsourcing vs. Self-Management: Clinical Trial Management in Med Device & Drug Development

CMS Proposes TCET Pathway for Faster Medicare Access to Medical Innovations

NEXT Oncology joins Proxima Clinical Research Early Phase Oncology Network to Advance Investigational Cancer Therapies

Dedicated Regulatory Team Takes Charge Of An FDA 510(k) Review

What is a Notified Body?

FDA Registration - What it Means & What It Doesn't

Paper Based vs. Electronic QMS

What is An Investigational Device Exemption (IDE)?

Significant Risk vs. Non-Significant Risk In Device Clinical Trials

Applying For a Product Development CPRIT Grant

Types of Drug and Biologic Submissions

The Relationship Between Clinical Trials and Regulatory Affairs

The Difference Between FDA Registered, Cleared, Granted, Authorized and Approved

Examples of SaMD Products

Can You Use Your Manufacturer's QMS?

When Should You Start a QMS?

Advancing Cancer Research With CPRIT's 3 Programs

What is a Wellness Device?

Design Controls

What Is Substantial Equivalence?

Classifying Medical Device Trials

BDD vs. STeP

Types of Medical Device Trials

What Is The Special 510(k)?

What is ISO 13485?

The Q Submission Program

Top 5 Considerations When Selecting a CRO for MedTech or Biotech Companies

What Are Pre-Submissions?

When And Why You Should Have An Informational Meeting

Informational Meetings

Breakthrough Device Designation Timeline

Breakthrough Device Designation

What Are The 3 Types of FDA Pre-Market Submissions?

Classifying Your Medical Device

How the FDA Classifies Medical Devices

How To Tell If Your Product Can Be Defined As a Medical Device?

Greenlight Guru's Demystifying BDD & STeP Processes Webinar

Breakthrough Device Designation FDA Timeline Infographic

Traditional 510(k) Timeline Infographic

Intro to PMA

Medical Device GMP

Intro to 510(k)

Medical Device Regulatory Assessments

Medical Device Risk Assessment

Medical Devices 101

Breakthrough Device Designation

Guide to Medical Device Labeling

Guide to Effective Medical Device Pre-Sub Meetings

Medical Device Design Controls

Intro to De Novo

Intro to HDE

Intro to ISO 13485

Intro to IVD

Intro to SaMD

Medical Device Benefit Risk Assessments

Early Phase Oncology Fact Sheet