FDA compliance for medical device manufacturers.

Classification decides everything else

Before anything else, the device's classification and product code determine the regulatory route. Most Class I devices are exempt from premarket notification. Most Class II devices require a 510(k) demonstrating substantial equivalence to a legally marketed predicate. Class III devices generally require premarket approval supported by clinical evidence. Choosing a predicate badly is the most common reason a 510(k) falls into repeated cycles of Additional Information requests.

The quality system

Manufacturers must operate a quality system covering design, production and post-market activities. FDA's Quality Management System Regulation aligns 21 CFR 820 with ISO 13485, so a firm already certified to 13485 starts from a strong position — but alignment is not identity. FDA-specific expectations for records, complaint handling and reporting still have to be built in explicitly.

Obligations that do not end at clearance

• Establishment registration and device listing, renewed annually.
• Unique Device Identification and submission of data to the GUDID.
• Medical Device Reporting for deaths, serious injuries and certain malfunctions.
• Reporting of corrections and removals.
• Labeling, and where applicable electronic product radiation control requirements.

What we do

• Classification and predicate analysis before a submission is written.
• 510(k) preparation, and drafting responses to Additional Information letters.
• Quality system gap analysis and remediation against 21 CFR 820 and ISO 13485.
• Inspection readiness, and drafting written responses to Form 483 observations.
• Import alert work where devices have been listed as unapproved or misbranded.

Common questions

We hold ISO 13485. Is that enough for FDA?

It is most of the way there, but not all of it. FDA harmonised Part 820 with ISO 13485 and still layers its own requirements on top: registration, listing, UDI, MDR reporting, and specific record expectations during inspection.

How long does a 510(k) take?

FDA's review clock is measured in decision days, but calendar time depends almost entirely on how many Additional Information requests the submission triggers. A well-built submission with a defensible predicate clears far faster than a thin one, and the difference is usually months.

Can we sell while the 510(k) is pending?

No. A device requiring premarket notification may not be commercially distributed in the United States until FDA issues a substantially equivalent determination.

What happens after a Form 483?

You should respond in writing, normally within fifteen working days, with corrections, a plan and dates. A complete and specific response often prevents escalation to a Warning Letter. A defensive or vague one rarely does.