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Grace Powers

@gracepowers

Regulatory Affairs #FDA #RAC, Medical Device Engineer, life science networker, entrepreneur, consultant, football fan #medtech #medicaldevice #regulatory

 Atlanta, GA (most of the time)
powersregulatory.com
Joined February 2009
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628Media
Photo by Grace Powers (@gracepowers)Photo by Grace Powers (@gracepowers)Photo by Grace Powers (@gracepowers)Photo by Grace Powers (@gracepowers)Photo by Grace Powers (@gracepowers)Photo by Grace Powers (@gracepowers)Photo by Grace Powers (@gracepowers)Photo by Grace Powers (@gracepowers)Photo by Grace Powers (@gracepowers)Photo by Grace Powers (@gracepowers)
The Material Difference: FDA Warning Letters Reinforce 510(k) Expectations for Material Changes buff.ly/sN0Iscu
The Material Difference: FDA Warning Letters Reinforce 510(k) Expectations for Material Changes

The Material Difference: FDA Warning Letters Reinforce 510(k) Expectations for Material Changes

Two recently published FDA warning letters caught our attention as they cite manufacturers for failing to submit a 510(k) for changes to device materials. FDA’s guidance Deciding When to Submit a 5…

thefdalawblog.com
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PFAS in Medical Devices: What You Need to Know buff.ly/PETg6Lr
PFAS in Medical Devices: What You Need to Know

PFAS in Medical Devices: What You Need to Know

Health concerns associated with PFAS do not apply to medical devices, which rely on a different type of material. The FDA explains the facts.

fda.gov
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FDA Authorizes First Wearable Device That Continuously Monitors Both Ketone Levels and Blood Sugar New device can help people with diabetes detect warning signs of a dangerous complication before it becomes a medical emergency buff.ly/dzv7gsg
FDA Authorizes First Wearable Device That Continuously Monitors Both Ketone Levels and Blood Sugar

FDA Authorizes First Wearable Device That Continuously Monitors Both Ketone Levels and Blood Sugar

The U.S. Food and Drug Administration today authorized the Libre Duo 10 Day Continuous Dual Glucose Ketone Monitoring System for people aged 2 years and older living with diabetes.

fda.gov
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FDA Approval Timelines Found to Be More Challenging in 2026 BTIG analysts issue a report on FDA approval numbers and timelines in 2026 compared to 2025. buff.ly/U2nsoJO
FDA Approvals Are up, But Timing Is a Challenge in 2026

FDA Approvals Are up, But Timing Is a Challenge in 2026

According to BTIG analysts, FDA approval numbers are higher than in 2025, but it's taking longer to reach FDA approval. Learn more about the report.

mddionline.com
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SBIA Presents Live Panel One for ClinicalTrials.gov: Essentials for Academic Medical Centers Live Panel One: Tuesday, July 14: 1:00 PM ET buff.ly/nZvrQdI
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Wearables Have Won Over Consumers. Now They're Coming for the Clinic A decade after Fitbit's IPO, wearable adoption has reached 46% of U.S. adults, with users wearing devices nearly constantly & increasingly bringing their data into clinical conversations. buff.ly/vZMyuB7
Image from Grace Powers (@gracepowers)
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Intent to Exempt Certain Unclassified Medical Devices from Premarket Notification Requirements Guidance for Industry and Food and Drug Administration Staff JUNE 2026 buff.ly/IvtdPCZ
Exemption of Certain Unclassified Devices from Premarket Requirements

Exemption of Certain Unclassified Devices from Premarket Requirements

Updated guidance includes five product codes FDA believes meets the standards for exemption from premarket notification (510(k)) requirements

fda.gov
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CDRH and Real-World Evidence CDRH Real-World Evidence Program Updated webpage! buff.ly/OxdzV8g
CDRH and Real-World Evidence

CDRH and Real-World Evidence

CDRH Real-World Evidence Program

fda.gov
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One Day at a Time: FDA’s New AI-Informed Inspection Pilot and What It Means for Industry buff.ly/EGJai2B
One Day at a Time: FDA’s New AI-Informed Inspection Pilot and What It Means for Industry

One Day at a Time: FDA’s New AI-Informed Inspection Pilot and What It Means for Industry

We have written on this blog about FDA’s modernization agenda from several angles lately—from the psychedelics Executive Order to the peptide compounding landscape (part 1, part 2)—but here is a st…

thefdalawblog.com
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Town Hall – Content of Human Factors Information in Medical Device Marketing Submissions, Final Guidance JULY 22, 2026 buff.ly/1nRA3P2
CDRH Town Hall – Human Factors in Medical Device Submissions

CDRH Town Hall – Human Factors in Medical Device Submissions

The FDA will discuss the Content of Human Factors Information in Medical Device Marketing Submissions, Final Guidance, issued on May 28, 2026.

fda.gov
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CDRH's Experiential Learning Program (ELP) buff.ly/XWPE4Zg Open again for 2026!
CRDH Experiential Learning Program (ELP)

CRDH Experiential Learning Program (ELP)

The Experiential Learning Program (ELP) is a collaborative approach to closing the knowledge gap between emerging and innovative technology and the pre-market r

fda.gov
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“Sounds Great. Do You Want FDA Approval?” A Regulatory Analysis of Psychedelics buff.ly/PJ38WvN
“Sounds Great. Do You Want FDA Approval?” A Regulatory Analysis of Psychedelics

“Sounds Great. Do You Want FDA Approval?” A Regulatory Analysis of Psychedelics

We have covered a lot of ground on this blog over the years:  Hatch-Waxman disputes, REMS programs, and everything in between.  Rarely have we had occasion to write a sentence like this one:  A pod…

thefdalawblog.com
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FDA Announces New Real-Time Clinical Trial Initiative to Expedite Development, but at What Cost? buff.ly/DZmcO1v
FDA Announces New Real-Time Clinical Trial Initiative to Expedite Development, but at What Cost?

FDA Announces New Real-Time Clinical Trial Initiative to Expedite Development, but at What Cost?

On Tuesday, April 28, FDA issued a press release announcing two major steps it is taking to advance the implementation of real-time clinical trials (“RTCTs”), including two proof-of-concept RTCTs, …

thefdalawblog.com
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CMS and FDA Announce RAPID Coverage Pathway to Accelerate Patient Access to Life-Changing Medical Devices buff.ly/NM5fIpR

CMS and FDA Announce RAPID Coverage Pathway to Accelerate Patient Access to Life-Changing Medical...

content.govdelivery.com
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Results May Vary, But Reporting Shouldn’t: FDA Sends a Not-So-Gentle Reminder on ClinicalTrials.gov Compliance buff.ly/rGygPEi
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FDA Looks East—Here’s What Industry Needs to Know buff.ly/94XkbKm
FDA Looks East—Here’s What Industry Needs to Know

FDA Looks East—Here’s What Industry Needs to Know

If you’ve been tracking FDA’s international presence, you know FDA has been through a bit of a roller coaster over the past decade.  After consolidating from 13 foreign offices down to 8 between 20…

thefdalawblog.com
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FDA Reminds More Than 2,200 Sponsors and Researchers to Disclose Trial Results buff.ly/1g5cC6P

FDA Reminds More Than 2,200 Sponsors and Researchers to Disclose Trial Results

content.govdelivery.com
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Recording is available! Town Hall – Clinical Decision Support Software, Final Guidance MARCH 11, 2026 buff.ly/g0xFali
Town Hall – Clinical Decision Support Software, Final Guidance

Town Hall – Clinical Decision Support Software, Final Guidance

Learn about updates to the FDA’s Clinical Decision Support Software, Final Guidance.

fda.gov
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Who Qualifies for the New FDA PreCheck Pilot Program? buff.ly/Och4IlY
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