Proxima Resource Hub

Have a question or need some insight into the healthcare industry? Our experts have you covered.
Check our guides on regulatory, clinical, and quality management resources for Biotech & MedTech.

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FAQ

Could the software change significantly affect clinical functionality or performance specifications that are directly associated with the intended use of the device?

FAQ

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

FAQ

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

FAQ

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

FAQ

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

FAQ

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

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

FAQ

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

FAQ

What is the special 510(k) program?

FAQ

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

FAQ

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

FAQ

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

FAQ

What is included in a De Novo Pre-Sub?

FAQ

What are the refuse to accept principles?

FAQ

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

FAQ

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

FAQ

What information is required for a De Novo request?

FAQ

What is the definition of a noninvasive device?

FAQ

What are the tiers for cybersecurity risk?

FAQ

What is considered to be a “trustworthy device”?

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How can manufacturers identify and protect device assets and functionality?

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

FAQ

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

FAQ

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

FAQ

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

FAQ

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

FAQ

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

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

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

FAQ

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

FAQ

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

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

FAQ

What device investigations are subject to IDE regulation?

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What device investigations are exempt from IDE regulation?

FAQ

What is the Consent Process?

FAQ

What elements must be included in the Informed Consent Document?

FAQ

How can informed consent be obtained from illiterate English-speaking subjects?

FAQ

What is an "assurance" or a "multiple project assurance," and are assurances required by the FDA?

FAQ

The informed consent regulations require the consent document to include a statement that notes the possibility that FDA may inspect the records. Is this statement a waiver of the subject's legal right to privacy?

FAQ

Are there alternatives to obtaining informed consent from a subject?

FAQ

Do Radioactive Drug Research Committees (RDRCs) have authority to approve initial clinical studies in lieu of an IND?

FAQ

Does FDA require the informed consent document to contain a space for assent by children?

FAQ

What happens when a study subject at one institution is admitted to another facility for treatment / hospitalization not related to the research?

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What happens when a study subject at one institution is admitted to a second institution for a reasonably foreseeable reason and as an anticipated part of the study protocol?

FAQ

When a secondary research facility is used, how should informed research consent be documented?

FAQ

What should you do if your device undergoes a labeling change?

FAQ

What should you do if your device undergoes a technology, engineering, or performance change?

FAQ

What should you do if your device undergoes a material change?

FAQ

If your device is an In Vitro Diagnostic Device, what should you do if your device undergoes a technology, engineering, performance, or material change?

FAQ

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

FAQ

How does FDA classify medical devices?

FAQ

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

FAQ

What statute and regulations apply to medical device clinical investigations?

FAQ

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

FAQ

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

FAQ

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

FAQ

What regulation describes custom devices?

FAQ

Can a physician use an unapproved device in an emergency?

FAQ

How are Medical Device Clinical Trials categorized?

FAQ

How are Biopharma Clinical Trials categorized?

FAQ

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

FAQ

Are IRBs Inspected by FDA?

FAQ

What happens after the FDA inspects a clinical investigator?

FAQ

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

FAQ

When are IRB inspections conducted?

FAQ

How are IRB inspections conducted?

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What happens after an IRB inspection?

FAQ

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

FAQ

What is an Exploratory IND approach?

FAQ

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

FAQ

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

FAQ

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

FAQ

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?

FAQ

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?

FAQ

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

FAQ

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

FAQ

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

FAQ

What is the abbreviated 510(k) program?

FAQ

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

FAQ

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

FAQ

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

FAQ

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

FAQ

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

FAQ

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

FAQ

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

FAQ

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

FAQ

What does the FDA consider to be valid scientific evidence?

FAQ

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

FAQ

What factors should manufacturers consider in addressing cybersecurity?

FAQ

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

FAQ

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

FAQ

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

FAQ

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

FAQ

What constitutes extraordinary cost?

FAQ

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?

FAQ

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?

FAQ

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

FAQ

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

FAQ

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?

FAQ

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

Glossary

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Glossary

Premarket Approval (PMA)

Glossary

Predicate Device

Glossary

Humanitarian Use Device (HUD)

Glossary

Humanitarian Device Exemption (HDE)

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Medical Device Directive

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European Union’s Medical Device Regulation (EUMDR)

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Glossary

Glossary

Good Laboratory Practice (GLP)

Glossary

Serious Adverse Event (SAE)

Glossary

Software as a Medical Device (SaMD)

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Glossary

Investigational Device Exemption (IDE)

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Good Clinical Practice (GCP)

Glossary

New Drug Application (NDA)

Glossary

Investigational New Drug Application (IND)

Glossary

Informed Consent Form (ICF)

Glossary

Institutional Review Boards (IRB)

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In Vitro Diagnostic (IVD)

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Glossary

Glossary

Glossary

General Control

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Special Control

Glossary

Quality Management System

Glossary

International Conference on Harmonization (ICH)

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Exploratory IND

Glossary

Abbreviated New Drug Application (ANDA)

Glossary

Cooperative Research

Glossary

Code of Federal Regulations (CFR)

Glossary

Glossary

Glossary

Glossary

Software as a Medical Device (SaMD) and Examples

Glossary

CAPA (Corrective and Preventive Actions)

Glossary

Medical Device Reporting (MDR)

Insights

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

Insights

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

Insights

FDA Issues Final Guidance: Device Software Functions and Premarket Submissions

Insights

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

Insights

The Conception of Ideas | Inventing Tomorrow Podcast

Insights

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

Insights

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

Insights

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

Insights

Safer Technologies Program (STeP) Breakdown

Insights

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

Insights

The Proxima Playbook: Understanding Your Biocompatibility Testing Requirements

Insights

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

Insights

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

Insights

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

Insights

FDA Rollouts Innovation and Improvements to Medical Device Sterilization

Insights

Meet the Innovator: John Zellmer, MBA.

Insights

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

Insights

Breakthrough Device Designation Reimbursement

Insights

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

Insights

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

Insights

Clinical Decision Support Software Guidance

Insights

Why Your CRO Should Be With You From Concept to Commercialization

Insights

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

Insights

Global Medical Device Podcast: Preparing for EU MDR

Insights

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

Insights

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

Insights

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

Insights

Clinical Trials: Risky Business

Insights

Tackling ISO 10993-12 Biocompatibility

Insights

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

Insights

Top 3 Benefits of Breakthrough Device Designation or STeP Designation

Insights

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

Insights

Major Guidance Changes to Artificial Intelligence and Machine Learning

Insights

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

Insights

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

Insights

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

Insights

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

Insights

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

Insights

All About About ASCA

Insights

Demystifying De Novo

Insights

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

Insights

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

Insights

Greenlight Guru Webinar: Is Regulation Necessary for Quality?

Insights

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

Insights

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

Insights

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

Insights

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

Insights

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

Insights

Expert Tips For Writing Your Clinical Trial Protocol

Insights

5 Key Strategies for Clinical Trial Patient Recruitment

Insights

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

Insights

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

Insights

Galen Data Webinar: Reducing AI Risk to Secure Regulatory Approval

Insights

Addressing Bias in AI for Medical Applications: A Comprehensive Guide

Insights

2023 And Me | The Proxima Post

Insights

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

Insights

CMS Proposes TCET Pathway for Faster Medicare Access to Medical Innovations

Case Study

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

Video

What is a Notified Body?

Video

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

Video

Paper Based vs. Electronic QMS

Video

What is An Investigational Device Exemption (IDE)?

Video

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

Video

Applying For a Product Development CPRIT Grant

Video

Types of Drug and Biologic Submissions

Video

The Relationship Between Clinical Trials and Regulatory Affairs

Video

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

Video

Examples of SaMD Products

Video

Can You Use Your Manufacturer's QMS?

Video

When Should You Start a QMS?

Video

Advancing Cancer Research With CPRIT's 3 Programs

Video

What is a Wellness Device?

Video

Design Controls

Video

What Is Substantial Equivalence?

Video

Classifying Medical Device Trials

Video

Video

Types of Medical Device Trials

Video

What Is The Special 510(k)?

Video

What is ISO 13485?

Video

The Q Submission Program

Video

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

Video

What Are Pre-Submissions?

Video

When And Why You Should Have An Informational Meeting

Video

Informational Meetings

Video

Breakthrough Device Designation Timeline

Video

Breakthrough Device Designation

Video

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

Video

Classifying Your Medical Device

Video

How the FDA Classifies Medical Devices

Video

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

Video

Greenlight Guru's Demystifying BDD & STeP Processes Webinar

Tools & Templates

Breakthrough Device Designation FDA Timeline Infographic

Tools & Templates

Traditional 510(k) Timeline Infographic

Tools & Templates

Tools & Templates

Tools & Templates

Tools & Templates

Medical Device GMP

Tools & Templates

Intro to 510(k)

Tools & Templates

Medical Device Regulatory Assessments

Tools & Templates

Medical Device Risk Assessment

Tools & Templates

Medical Devices 101

Tools & Templates

Breakthrough Device Designation

Tools & Templates

Guide to Medical Device Labeling

Tools & Templates

Guide to Effective Medical Device Pre-Sub Meetings

Tools & Templates

Medical Device Design Controls

Tools & Templates

Intro to De Novo

Tools & Templates

Tools & Templates

Intro to ISO 13485

Tools & Templates

Medical Device Benefit Risk Assessments

Tools & Templates

Early Phase Oncology Fact Sheet

Proxima Newsletter

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