AMP FDA Rule Laboratory Practice / Compliance Question Submission Form

PURPOSE & INSTRUCTIONS

AMP molecular professionals have many operational questions about how to implement the final FDA Rule within their clinical laboratories. The purpose of this form is to gather clinical laboratory practice or compliance related questions and submit them to the FDA with a request for additional guidance.

INSTRUCTIONS

AMP will compile all questions received and submit them to the FDA every 14 business days. You may also upload a limited size supporting document with your question. AMP will post the questions and any answers received on our FDA RULE RESOURCES FOR LABORATORIES website.

For more information, contact AMP Clinical & Scientific Affairs. To submit policy or advocacy related questions to the FDA, use the form located at www.amp.org/ldt.

Question Title

* 1. Name:

Question Title

* 2. Address (optional):

Question Title

* 3. Institution/Organization (optional):

Question Title

* 4. Email:

Question Title

* 5. Phone (optional):

Question Title

* 6. Which of the following BEST describes your clinical laboratory institution/organization?

Academic medical center

Health system/HMO, for-profit

Health system/HMO, not-for-profit

Hospital, for-profit

Hospital, not-for-profit

Private lab

Tribal health system/hospital

Commercial reference/referral

Other (please specify)

Question Title

* 7. Topic of your Laboratory Practice / Compliance Question:

Acceptance Activities

Corrective & Preventative Actions

Design Controls

High-risk In Vitro Diagnostic (IVD) Classification

Investigational Device Exemption (IDE)

Labeling

Laboratory Operations

LDT Validation

MDR Complaint File

MDR Correction & Removal Reporting

Medical Device Reporting (MDR)

Predetermined Change Control Plans for Medical Devices

Premarket Approval Application (PMA)

Purchasing Controls

Quality Systems Management

Records Requirements

Reference / Referral / Outreach Testing

Registration & Listing

CLIA - Accreditation Body - FDA Overlap

Other (please specify)

Question Title

* 8. Laboratory Practice / Compliance Question for FDA:

Question Title

* 9. What identifying (or potentially identifying) information may we share with the FDA and/or on our resources webpage/in public?

	FDA	Webpage/public
Name	Name FDA	Name Webpage/public
Institution/Organization Type	Institution/Organization Type FDA	Institution/Organization Type Webpage/public
Contact Information (FDA only)	Contact Information (FDA only) FDA	Contact Information (FDA only) Webpage/public