Your Shopping Cart
By using this site you agree to our use of cookies. Please refer to our privacy policy for more information. Close
Hello. Sign In
Your Account

Log In to ComplianceOnline
Welcome back! Please log in below to continue.
0
Cart
Toll Free:
+1-888-717-2436
+1-888-717-2436
Industries
- Banking & Financial Services
- BANKING & FINANCIAL SERVICES
- Banks and Credit Unions
- Financial Services and Trading
- Insurance
- Accounting and Taxation
- Life Sciences
- Hitech, Aero & Manufacturing
- HITECH, AERO & MANUFACTURING
- Quality & Safety
- Standards and Methodology
- Energy & Utilities
- ENERGY & UTILITIES
- IT Security
- Reliability (NERC / FERC)
- Quality and Safety
- Risk Management
- CPG & Retail
- CPG & RETAIL
- Retail Audit
- Quality & Safety
- Social Compliance
- Healthcare
- Food & Dietary Supplements
- Cross Industry Functions
Webinars
By Industries
Seminars
Quality Control Laboratory Compliance - cGMPs and GLPs
Process Validation Guidance Requirements (FDA and EU Annex 15: ...
FDA Recalls - Before You Start, and After You Finish
Biostatistics for the Non-Statistician
Data Integrity: FDA/EU Requirements and Implementation
Managing Domestic and Foreign FDA Inspections and the ...
Recordkeeping and Documentation in a GLP Laboratory ...
Reduce costs for compliance with data integrity: 21 CFR Part 11 ...
Change Control Best Practices - Avoiding Unintended ...
Technical Writing for Pharma, Biotech and Medical Devices
Standards
Aerospace
Agriculture and Farm Machinery
Automotive, Aircraft & Marine technology
Banking, Corp. finance & Sox
Biotech & Pharmaceutical Standards
Chemical technology
Civil engineering and construction
Computer Hardware
Electrical Engineering
Electronic Equipment
ANSI
Audit Net
BIN
BPA
Business Basics
Complianceonline
IT Governance
LabCompliance
Quality-Control-Plan
RCGLOBAL
SHOQ Quality Assurance Manuals
SEPT
Home
› Best Practices
FDA Proposes Guidelines to Clarify Benefit-Risk Determinations for Medical Devices
- By: Staff Editor
- Date: August 19, 2011
The FDA’s new draft guidelines focus on premarket approval applications (PMAs), the regulatory pathway for high-risk medical devices. The recommendations made in the guidance are, according to the agency, intended to improve the predictability, consistency and transparency of the premarket review process for applicable devices, and should help manufacturers go through the approval process easier.
Device reviewers also may consider whether the device is new or a first-of-a-kind technology as part of the benefit-risk determination, particularly if the device treats a disease that has no other treatment.
Need to improve your firm’s compliance with medical device regulations? Then attend the following ComplianceOnline webinars:
|
||
Summary of recommendations
Applicability
The guidance applies to:
- Devices subject to premarket approval (PMA) applications
- In limited cases, devices subject to premarket notification (510(k)) requirements
- Both diagnostic devices and therapeutic devices
Safety and effectiveness data
When reviewing PMAs, the FDA uses safety data and effectiveness data:
- The safety data addresses risk, and the manufacturer’s ability to mitigate that risk.
- The effectiveness data considers benefits, as well as other information, to determine whether the probable benefits outweigh the probable risks associated with use of the device.
Safety and effectiveness data alone may not provide a complete picture of the benefits and risks. FDA medical device reviewers objectively look at other factors such as the severity of the disease the product diagnoses or treats and whether or not alternative tests or treatments are available.
Both clinical and non-clinical data can play a role in the FDA’s benefit-risk determinations.
Factors FDA considers in making benefit-risk determinations
Measures for effectiveness of devices:
The type of benefits |
|
The magnitude of the benefits in the individual patient |
|
The probability of the patient experiencing a benefit |
|
The duration of effects |
|
Measures for safety of devices
The extent of the probable risk/harm is measured by taking into account the following factors:
Number, severity, and types of harmful events associated with the use of the device |
|
Probability of a harmful event | The percent of the intended population that would expect to experience a harmful event. |
Duration of harmful events | Some devices can cause temporary, minor harm; some devices can cause repeated but reversible harm; and other devices can cause permanent, debilitating injury. |
Risk from false-positive or false-negative for diagnostics |
|
The agency also considers the number of different types of harmful events that can potentially result from using the device and the severity of their aggregated effect. When multiple harmful events occur at once, they have a greater aggregated effect.
Additional factors for risk/benefit determination
Uncertainty |
The degree of certainty of the benefits and risks of a device is a factor the FDA considers when making benefit-risk determinations. |
Characterization of the disease |
|
Patient tolerance for risk | Different factors can influence patient risk tolerance, including:
|
Risk mitigation | The use of mitigations such as warning labels can minimize the likelihood of a harmful event occurring. |
Novelty of technology | Devices representing or incorporating new technologies, especially those that are first-of-a-kind, may provide a less than optimal benefit, but may also offer advantages that did not previously exist. |
Benefit/risk worksheet
The guidance proposes that medical device reviewers use a worksheet to document how they make benefit-risk determinations. In certain cases, this document could be made public post-approval, making the FDA’s decision making process even more transparent.
Additional resources
- Read the draft FDA guidance for benefit risk determination of medical devices in full
Compliance Trainings

Pregnancy in the Workplace: Strategies to Protect Your Organization from Pregnancy Discrimination Claims
By - Christopher W. Olmsted
On Demand Access Anytime
By - Christopher W. Olmsted
On Demand Access Anytime

How to Vet an IRB: Expose and Fix Problems Before They Threaten Your Trial
By - Madhavi Diwanji
On Demand Access Anytime
By - Madhavi Diwanji
On Demand Access Anytime

Compliance Standards
Best Sellers
- Add to Cart
- Add to Cart
- Add to Cart
- Add to Cart
- Add to Cart
- Add to Cart
- Add to Cart
- Add to Cart
-
By: Miles HutchinsonAdd to CartPrice: $249
- Add to Cart
- Add to Cart
- Add to Cart
- Add to Cart
- Add to Cart
- Add to Cart
-
San Francisco, CA | Aug 6-7, 2020
-
Virtual Seminar | Jul 16-17, 2020
-
Virtual Seminar | Jun 18-19, 2020
-
Los Angeles, CA | Aug 20-21, 2020
-
Virtual Seminar | Jul 16-17, 2020
-
Virtual Seminar | Jun 25-26, 2020
-
Virtual Seminar | Jun 10, 2020
-
Virtual Seminar | Jun 3-4, 2020
-
Virtual Seminar | Jul 6-7, 2020
-
San Francisco, CA | Oct 22-23, 2020
-
Virtual Seminar | Jul 9-10, 2020
-
Virtual Seminar | Jun 3-4, 2020
-
Virtual Seminar | June 3-4, 2020
-
Miami, FL | Jul 29-31, 2020
-
Virtual Seminar | Jun 17, 2020
-
Provider: ANSIAdd to CartPrice: $142
- Add to Cart
- Add to Cart
- Add to Cart
-
Provider: ANSIAdd to CartPrice: $120
-
Provider: ANSIAdd to CartPrice: $250
-
Provider: SEPTAdd to CartPrice: $299
- Add to Cart
-
Provider: Quality-Control-PlanAdd to CartPrice: $37
- Add to Cart
-
Provider: At-PQCAdd to CartPrice: $397
- Add to Cart
- Add to Cart
- Add to Cart
- Add to Cart
You Recently Viewed
