FDA ASCA Testing — Accredited Laboratories & What the Programme Covers

When is it used?

• Planning a submission where testing to an ASCA-eligible standard is required
• Choosing between laboratories where one participates in ASCA and another does not
• Deciding whether ASCA-supported testing helps a particular submission strategy
• Verifying a laboratory's claim about ASCA participation

Sample considerations

• ASCA participation applies to a specific laboratory for specific standards — a laboratory can be accredited for one standard and not another.
• Confirm scope against FDA's published information as well as with the laboratory before booking.
• Most testing laboratories are not ASCA-accredited; that says nothing about their technical competence for other work.
• ASCA is voluntary. Testing outside the programme remains acceptable, it is simply reviewed differently.

Laboratories with relevant capabilities

No directory profile currently documents this specific capability. Submit a request and we will look for laboratories that cover it.

Frequently asked questions

Do laboratories listed on Laboratory Vortex participate in ASCA?

Some may, most do not, and participation is standard-specific. We show ASCA only where a laboratory's participation is stated by a source we can point to, and you should still verify current scope with FDA's published information and with the laboratory.

Is ASCA required?

No. It is a voluntary programme intended to streamline review of conformity assessment for eligible standards. Testing outside it remains acceptable.

Which standards are eligible?

The eligible list is defined and updated by FDA and includes standards in the electrical safety, EMC and biocompatibility areas. Check FDA's current published list rather than relying on a summary.