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While You Were Away: CDRH Announces Pilot Voluntary Quality Compliance Program
January 11, 2018By Allyson B. Mullen —While many were on vacation and preparing to celebrate the New Year, CDRH was announcing yet another pilot program. You may recall FDA recently announced its Digital Health Software Pre-Cert Pilot Program and its Premarket Approval Application Critical to Quality Pilot Program. The latest pilot program is the Case for Quality Voluntary Medical Device Manufacturing and Product Quality Pilot Program. The program was announced in the Federal Register.
This pilot program, like others that have come before it, intends to evaluate alternative means of assessing a device company’s quality system. In this program, CDRH has collaborated with the Medical Device Innovation Consortium (MDIC) to develop a “maturity model and appraisal system,” the Capability Maturity Model Integration (CMMI) system. Details regarding the CMMI system are absent from the Federal Register notice. Prospective participants would be well-advised to better understand this system prior to enrollment. Program participants will be required to perform a gap assessment using the CMMI system. In exchange, FDA intends to forego conducting surveillance inspections of program participants.
CDRH will select up to nine companies to participate in this program, and it began taking applications for enrollment on January 2. The program is scheduled to run through the end of 2018.
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- FDA Stealthily Convenes Multi-Cancer Testing Panel Meeting November 28, 2023
- Silence Isn’t Golden: Two Executives Convicted in First Criminal Prosecution Under the Consumer Product Safety Act November 28, 2023
- FDA Proposes to Ban Brominated Vegetable Oil in Food November 23, 2023
- Going to 11: New Subsections at CDER’s Office of Pharmaceutical Quality Are Important Piece of FDA’s Inspection and Enforcement Strategy November 20, 2023
- HP&M Recognized by Best Law Firms® as National Tier 1 – FDA Law and Regional Washington, DC Tier 1 – FDA Law (2024 Edition) November 15, 2023
- Big Molecule Watch Blog
- Bloomberg BNA Health Care Blog
- Drug and Device Law Blog
- Eye on FDA
- FDA Matters
- Harvard Law Bill of Health
- IN VIVO Blog
- Internet Drug News.com
- Lachman Consultants Blog
- Medical Devices Today
- Orange Book Blog
- The Orange Book Insights Blog
- Pharma IQ
- Pharmalot
- SCOTUS Blog
- The Volokh Conspiracy
- WLF Legal Pulse
- Advertising and Promotion (Federal Trade Commission)
- Advertising and Promotion (OPDP)
- Animal Drugs and Feeds
- Biosimilars
- Cannabis
- cGMP Compliance
- Consumer Product Safety Commission
- Controlled Substances
- Cosmetics
- COVID19
- Current Affairs
- Dietary Supplements
- Drug Development
- Drug Enforcement Administration
- Enforcement
- FDA News
- Foods
- Foods and Dietary Supplements
- Fraud and Abuse
- Government Pricing
- Hatch-Waxman
- Health Care
- Health Privacy
- Import/Export
- In Vitro Diagnostic Devices
- Jobs
- Medical Devices
- Miscellaneous
- Orphan Drugs
- OTC Drugs and Cosmetics
- Prescription Drugs and Biologics
- Product Jurisdiction and Combination Products
- Reimbursement
- Tissue Products
- Tobacco
- Uncategorized