The FDA requires devicemakers to verify that a product meets each of its design specifications, which is generally accomplished through postproduction inspection or testing. Read More

Although a quality agreement is not specifically required or defined in FDA regulations, the FDA may ask during an inspection to review any documents that describe the way you manage contract service providers. Read More

It’s possible to learn from failures resulting in unacceptable risks for combination drug-device-biologic products what design input requirements are essential to the safe and effective operation and use of such products, Susan Neadle, head of combination products at Johnson & Johnson, said at the World Drug Safety Congress Americas. Read More

It’s possible to learn from failures resulting in unacceptable risks for combination drug-device-biologic products what design input requirements are essential to the safe and effective operation and use of such products, Susan Neadle, head of combination products at Johnson & Johnson, said at the World Drug Safety Congress Americas. Read More

Russia’s Ministry of Health has rolled out new requirements for internal quality control and monitoring of the safety of devices in medical facilities. Read More

The National Electrical Manufacturers Association (NEMA) released a new quality management standard for servicing medical imaging equipment—designed to ensure equipment is returned to a safe and effective condition for its intended use. Read More

The FDA published draft guidance on metered dose and dry powder inhalers highlighting considerations for critical quality attributes. Read More

Facilities in India, Lithuania and Texas drew warnings from the FDA for a variety of noncompliances, including inadequate validations, designs and device history records. Read More

CDRH is looking to enroll a total of nine participants in its new pilot program aimed at identifying best practices for quality product manufacturing. Read More