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Blog: Blog2

MDUFA VI: Why FDA Device Reviews Are Getting Tougher, Not Faster

MDUFA VI: Why FDA Device Reviews Are Getting Tougher, Not Faster

MDUFA VI: Why FDA Device Reviews Are Getting Tougher, Not Faster

There's a quiet hope that keeps circulating among medical device companies eyeing the US market. "Maybe the next round of reforms will finally speed things up." Application volume keeps climbing while the reviewer headcount stays flat, so the thinking goes that the next policy overhaul has to bring some relief. The signal FDA just sent points the other way. Not faster. Tighter. MDUFA Isn't Just a Fee Schedule — It's a Five-Year Deal Between FDA and Industry Getting a device o

Provision Consulting Group

Aug 143 min read

FDA US Agent: What Happens When They Go Silent — and You Picked Them on Price

FDA US Agent: What Happens When They Go Silent — and You Picked Them on Price

FDA US Agent: What Happens When They Go Silent — and You Picked Them on Price

There's one decision that comes up again and again in US market entry projects: treating the choice of US Agent like a quote comparison. "It's just an address on a form — might as well go with whoever's cheapest." From a working-level perspective, that's a perfectly reasonable call. The problem is the assumption behind it. If a US Agent's job really were nothing more than renting out an address, that would be the right choice. But look at the actual responsibilities FDA regul

FDA Regulations

Provision Consulting Group

Jul 204 min read

Navigating the FDA’s Guidance on Orthopedic Non-Spinal Bone Plates, Screws, and Washers

Navigating the FDA’s Guidance on Orthopedic Non-Spinal Bone Plates, Screws, and Washers

Navigating the FDA’s Guidance on Orthopedic Non-Spinal Bone Plates, Screws, and Washers

November 25, 2024 The FDA’s recently issued guidance on orthopedic non-spinal bone plates, screws, and washers outlines crucial updates...

Provision Consulting Group

Nov 25, 20242 min read

Your Device Is FDA-Cleared. Who Is Your U.S. Initial Importer?

Your Device Is FDA-Cleared. Who Is Your U.S. Initial Importer?

Your Device Is FDA-Cleared. Who Is Your U.S. Initial Importer?

4 days ago

FDA Finalizes Mandatory Cosmetics Recall Guidance: What K-Beauty Brands Entering the U.S. Should Know

FDA Finalizes Mandatory Cosmetics Recall Guidance: What K-Beauty Brands Entering the U.S. Should Know

FDA Finalizes Mandatory Cosmetics Recall Guidance: What K-Beauty Brands Entering the U.S. Should Know

Oct 30

Renew Your FDA Initial Importer Designation with Provision

Renew Your FDA Initial Importer Designation with Provision

Renew Your FDA Initial Importer Designation with Provision

Oct 16

OTC Drug Establishment Renewal: Time to Renew with Provision

OTC Drug Establishment Renewal: Time to Renew with Provision

OTC Drug Establishment Renewal: Time to Renew with Provision

Oct 16

FDA Food Facility Registration: 2026 Is a Renewal Year

FDA Food Facility Registration: 2026 Is a Renewal Year

FDA Food Facility Registration: 2026 Is a Renewal Year

Oct 14

FY2027 FDA Medical Device Registration Renewal: It’s Time to Renew with Provision

FY2027 FDA Medical Device Registration Renewal: It’s Time to Renew with Provision

FY2027 FDA Medical Device Registration Renewal: It’s Time to Renew with Provision

Oct 14

FDA’s FY2027 Medical Device Guidance Agenda: What Could It Mean for 510(k) Manufacturers?

FDA’s FY2027 Medical Device Guidance Agenda: What Could It Mean for 510(k) Manufacturers?

FDA’s FY2027 Medical Device Guidance Agenda: What Could It Mean for 510(k) Manufacturers?

Oct 7

Provision CEO Sung Kwon to Speak at Cosmoprof Asia Hong Kong 2026

Provision CEO Sung Kwon to Speak at Cosmoprof Asia Hong Kong 2026

Provision CEO Sung Kwon to Speak at Cosmoprof Asia Hong Kong 2026

Oct 2

FDA’s Purolea Warning Letter: What AI-Assisted GMP Documentation Means for Manufacturers

FDA’s Purolea Warning Letter: What AI-Assisted GMP Documentation Means for Manufacturers

FDA’s Purolea Warning Letter: What AI-Assisted GMP Documentation Means for Manufacturers

Sep 23

FDA Form 483 Response Is Not the Finish Line: What the Bausch & Lomb Warning Letter Reveals About CAPA

FDA Form 483 Response Is Not the Finish Line: What the Bausch & Lomb Warning Letter Reveals About CAPA

FDA Form 483 Response Is Not the Finish Line: What the Bausch & Lomb Warning Letter Reveals About CAPA

Sep 19

FDA Sunscreen Regulatory Update: PABA and Trolamine Salicylate Removed from OTC Monograph M020

FDA Sunscreen Regulatory Update: PABA and Trolamine Salicylate Removed from OTC Monograph M020

FDA Sunscreen Regulatory Update: PABA and Trolamine Salicylate Removed from OTC Monograph M020

Sep 16

What Does It Mean When Torriden Delegates U.S. Regulatory Compliance to Provision Consulting Group?

What Does It Mean When Torriden Delegates U.S. Regulatory Compliance to Provision Consulting Group?

What Does It Mean When Torriden Delegates U.S. Regulatory Compliance to Provision Consulting Group?

Sep 9

Introducing the Provision Client Portal (Beta): A New Way to Work With Us

Introducing the Provision Client Portal (Beta): A New Way to Work With Us

Introducing the Provision Client Portal (Beta): A New Way to Work With Us

Sep 9

Why Provision Built R.I.S.E. Turning 50,000+ Real Regulatory Cases into Regulatory Intelligence

Why Provision Built R.I.S.E. Turning 50,000+ Real Regulatory Cases into Regulatory Intelligence

Why Provision Built R.I.S.E. Turning 50,000+ Real Regulatory Cases into Regulatory Intelligence

Aug 28

FY2027 FDA Medical Device User Fees Finalized: MDUFA V’s Final Year and What You Need to Know

FY2027 FDA Medical Device User Fees Finalized: MDUFA V’s Final Year and What You Need to Know

FY2027 FDA Medical Device User Fees Finalized: MDUFA V’s Final Year and What You Need to Know

Aug 24

Provision Consulting Group Speaks at ACI Conference on K-Beauty and U.S. Regulatory Challenges

Provision Consulting Group Speaks at ACI Conference on K-Beauty and U.S. Regulatory Challenges

Provision Consulting Group Speaks at ACI Conference on K-Beauty and U.S. Regulatory Challenges

Aug 18

MDUFA VI: Why FDA Device Reviews Are Getting Tougher, Not Faster

MDUFA VI: Why FDA Device Reviews Are Getting Tougher, Not Faster

MDUFA VI: Why FDA Device Reviews Are Getting Tougher, Not Faster

Aug 14

Trapped in Customs: The Hidden Triggers Behind FDA Import Alerts for Medical Devices

Trapped in Customs: The Hidden Triggers Behind FDA Import Alerts for Medical Devices

Trapped in Customs: The Hidden Triggers Behind FDA Import Alerts for Medical Devices

Aug 3

Container Stuck at a U.S. Port — What Triggers an FDA Import Alert for Food and Supplements

Container Stuck at a U.S. Port — What Triggers an FDA Import Alert for Food and Supplements

Container Stuck at a U.S. Port — What Triggers an FDA Import Alert for Food and Supplements

Jul 27

FDA US Agent: What Happens When They Go Silent — and You Picked Them on Price

FDA US Agent: What Happens When They Go Silent — and You Picked Them on Price

FDA US Agent: What Happens When They Go Silent — and You Picked Them on Price

Jul 20

What Huons' FDA Warning Letter Reveals About Today's CGMP Enforcement

What Huons' FDA Warning Letter Reveals About Today's CGMP Enforcement

What Huons' FDA Warning Letter Reveals About Today's CGMP Enforcement

Jun 30

FDA 510(k) Clearance: Why a "Complete" eSTAR Doesn’t Guarantee Approval

FDA 510(k) Clearance: Why a "Complete" eSTAR Doesn’t Guarantee Approval

FDA 510(k) Clearance: Why a "Complete" eSTAR Doesn’t Guarantee Approval

Jun 29

FDA Sunscreen Ingredient Update: Bemotrizinol Added to the U.S. OTC Monograph

FDA Sunscreen Ingredient Update: Bemotrizinol Added to the U.S. OTC Monograph

FDA Sunscreen Ingredient Update: Bemotrizinol Added to the U.S. OTC Monograph

Jun 23

A Kimchi Brand Just Got Recalled. The Culprit? Anchovies.

Jun 15

KOTRA x Provision Consulting Group to Support Korean Companies at BIO International Convention San Diego

KOTRA x Provision Consulting Group to Support Korean Companies at BIO International Convention San Diego

KOTRA x Provision Consulting Group to Support Korean Companies at BIO International Convention San Diego

Jun 11

The FDA is Cracking Down on Sunscreen Factories—Is Yours Truly Ready?

The FDA is Cracking Down on Sunscreen Factories—Is Yours Truly Ready?

The FDA is Cracking Down on Sunscreen Factories—Is Yours Truly Ready?

Jun 1

FDA-Compliant, Yet Still Sued? The Labeling Risks U.S.-Bound Brands Often Miss

FDA-Compliant, Yet Still Sued? The Labeling Risks U.S.-Bound Brands Often Miss

FDA-Compliant, Yet Still Sued? The Labeling Risks U.S.-Bound Brands Often Miss

May 15

Medical Devices Have IDs Too — The FDA UDI Guide for U.S. Market Entry

Medical Devices Have IDs Too — The FDA UDI Guide for U.S. Market Entry

Medical Devices Have IDs Too — The FDA UDI Guide for U.S. Market Entry

May 4

MoCRA Insight: Same Ingredients, Same Formula — Different FDA Interpretations

MoCRA Insight: Same Ingredients, Same Formula — Different FDA Interpretations

MoCRA Insight: Same Ingredients, Same Formula — Different FDA Interpretations

Apr 24

Longevity and In & Out Beauty: What K-Beauty Brands Are Missing in the U.S. Market

Longevity and In & Out Beauty: What K-Beauty Brands Are Missing in the U.S. Market

Longevity and In & Out Beauty: What K-Beauty Brands Are Missing in the U.S. Market

Apr 13

'Magnif's make p:rem', a K-Beauty Brand, Just Landed at Sephora. Here's What Made It Possible.

Mar 31

Why Your K-Clinic Launch Could Trigger an FDA "Drug Claim" — MoCRA Strategies for 2026

Why Your K-Clinic Launch Could Trigger an FDA "Drug Claim" — MoCRA Strategies for 2026

Why Your K-Clinic Launch Could Trigger an FDA "Drug Claim" — MoCRA Strategies for 2026

Mar 24

One Sunscreen Could Land You on FDA's Blacklist — Have You Checked Your OMUFA FY2026 Status?

One Sunscreen Could Land You on FDA's Blacklist — Have You Checked Your OMUFA FY2026 Status?

One Sunscreen Could Land You on FDA's Blacklist — Have You Checked Your OMUFA FY2026 Status?

Mar 13

Two More Digits. A Lot More Work. — FDA's NDC Format Change Explained

Two More Digits. A Lot More Work. — FDA's NDC Format Change Explained

Two More Digits. A Lot More Work. — FDA's NDC Format Change Explained

Mar 6

K-Beauty FDA Compliance: Why 'Marketing' Is No Longer Enough in the U.S. Market

K-Beauty FDA Compliance: Why 'Marketing' Is No Longer Enough in the U.S. Market

K-Beauty FDA Compliance: Why 'Marketing' Is No Longer Enough in the U.S. Market

Feb 24

[Cosmoprof Miami 2026] K-Beauty: Moving Beyond ‘Registration’ to ‘Regulatory Strategy’

[Cosmoprof Miami 2026] K-Beauty: Moving Beyond ‘Registration’ to ‘Regulatory Strategy’

[Cosmoprof Miami 2026] K-Beauty: Moving Beyond ‘Registration’ to ‘Regulatory Strategy’

Feb 16

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