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# PCCP Draft Guidance Stakeholder Recommendations
- URL: https://www.fdaweb.com/pccp-draft-guidance-stakeholder-recommendations/
- Published: 2024-11-20T12:00:00.000Z
- Updated: 2026-09-14T14:47:37.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5158232

After reiterating that it believes FDA lacks the authority to regulate laboratory-developed testing services, the American Clinical Laboratory Association (ACLA) submits comments on an FDA draft guidance on predetermined change control plans (PCCP) for medical devices “to ensure that PCCPs can be leveraged by laboratories to support continued rapid innovation of diagnostics to meet patient needs.” The ACLA comment [letter](https://www.regulations.gov/comment/FDA-2024-D-2338-0011?ref=fdaweb.com) says the modifications that would be appropriate for a PCCP under the draft guidance are too narrow to encourage meaningful iterative improvement of diagnostic without repeated cycles of premarket review.

“The types of modifications that are appropriate for a PCCP must be expanded,” the letter says. “The guidance also should clarify that a PCCP may allow modifications to a cleared or approved in vitro diagnostic (IVD) test kit to be implemented by high-complexity clinical laboratories, rather than the manufacturer of the IVD test kit without FDA premarket review. Finally, the statutory standard for evaluating a PCCP does not include an evaluation of the regulatory history of the subject device nor of the submitter, and accordingly, FDA should not take such histories into consideration.”

In its [comment](https://www.regulations.gov/comment/FDA-2024-D-2338-0019?ref=fdaweb.com), the Consumer Healthcare Products Association says it encourages FDA to provide further clarity on the content and process for PCCPs for four specific issues.