--- title: "Modular PMA, Definition | MedTech Terms" description: "PMA submission strategy where a manufacturer submits portions of the PMA (modules) sequentially as they become ready, rather than as a single complete…" lang: en json-ld: | { "@context": "https://schema.org", "@graph": [ { "@type": "DefinedTerm", "@id": "https://medtechterms.com/terms/pma-modular#term", "name": "Modular PMA", "alternateName": [ "Modular Premarket Approval", "PMA Modular Review" ], "description": "Modular PMA is a PMA submission strategy in which the sponsor agrees with FDA in advance on a defined set of modules, typically Preclinical, Manufacturing, and Clinical, that will be submitted separately as each is completed. FDA reviews each module as it arrives and provides feedback before the next module is filed. When all modules are complete and accepted, FDA closes the modular review and the PMA enters substantive review as a complete application. 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[Home](/) 2. / 3. [Terms](/terms) 4. / 5. [Regulatory](/terms?cat=Regulatory) 6. / 7. Modular PMA [All terms](/terms) Regulatory [Regulated Pathways](/ecosystems/regulated-pathways) # Modular PMA PMA submission strategy where a manufacturer submits portions of the PMA (modules) sequentially as they become ready, rather than as a single complete application. Reviewed by [Christian Espinosa, Founder, Blue Goat Cyber](/authors/christian-espinosa) Last reviewed June 20, 2026 ## Definition Modular [PMA](/terms/pma) is a PMA submission strategy in which the sponsor agrees with FDA in advance on a defined set of modules, typically Preclinical, Manufacturing, and Clinical, that will be submitted separately as each is completed. FDA reviews each module as it arrives and provides feedback before the next module is filed. When all modules are complete and accepted, FDA closes the modular review and the PMA enters substantive review as a complete application. Modular PMAs are most useful for devices with long clinical study durations, where preclinical and manufacturing data are ready years before clinical data. What the regulation says FDA describes the Modular [PMA](/terms/pma) pathway in the 'Premarket Approval Application Modular Review' guidance. The Q-Submission program is the mechanism for negotiating module structure before filing. ## What this means in practice Modular [PMA](/terms/pma) shortens the calendar time between final data and approval by parallelizing preparation and review. The trade-off is more upfront planning: the sponsor and FDA must agree on the module shell, contents, and order in a [pre-submission meeting](/terms/pre-submission). Sponsors should pursue modular PMA only when the savings are material, for small or fast-developing devices, a traditional PMA is often simpler. Common pitfalls - • Skipping the pre-submission negotiation of module scope, modules submitted without FDA agreement may be rejected or restarted. - • Treating modular review as a way to defer hard decisions, FDA may still raise major deficiencies that affect later modules. - • Underestimating the project management burden, three rounds of FDA review and response require more coordination than a single PMA. ## Related terms Grouped by theme ### Editor's picks · Hand-selected related concepts [ Regulatory PMA Supplement Types FDA's five-way taxonomy for post-approval PMA changes, Panel-Track, 180-Day, Real-Time, Special, and 30-Day Notice, each with distinct content and timing. ](/terms/pma-supplement-types)[ Regulatory Premarket Approval(PMA) FDA's most stringent device marketing application, required for high-risk Class III devices. ](/terms/pma)[ Regulatory Q-Submission (Pre-Submission)(Q-Sub / Pre-Sub) Voluntary mechanism to obtain FDA feedback before a formal premarket submission. ](/terms/q-sub)[ Regulatory Real-Time PMA Supplement Review Expedited PMA supplement review pathway where FDA and the manufacturer meet to review minor device or labeling changes in real time. ](/terms/pma-real-time-review) ### More in Regulatory · Same category [ Regulatory 510(k) Premarket Notification(510(k)) FDA submission demonstrating a device is substantially equivalent to a legally marketed predicate. ](/terms/510k)[ Regulatory 510(k) Summary vs 510(k) Statement Two alternative disclosure mechanisms in a 510(k) submission, a Summary is public on FDA's website; a Statement promises to share Safety & Effectiveness info on request. ](/terms/510k-summary-vs-statement)[ Regulatory 513(g) Request for Information(513(g)) Formal mechanism to ask FDA whether a product is a device and, if so, its likely classification. ](/terms/513g)[ Regulatory Abbreviated 510(k) 510(k) variant that relies on FDA guidance, special controls, or recognized consensus standards. ](/terms/abbreviated-510k) Cited by Where this term appears across MedTech Terms. Ecosystems (1) - [Regulated Pathways](/ecosystems/regulated-pathways) ## Primary references 3 sources Link health: 3 verified · last checked 2026-06-20 FDA· 1 European Commission· 1 IMDRF· 1 1. [1 PMA Modular Review Guidance Verified FDA · fda.gov ](https://www.fda.gov/regulatory-information/search-fda-guidance-documents/premarket-approval-application-modular-review) 2. [2 European Commission - Medical Devices Verified European Commission · health.ec.europa.eu ](https://health.ec.europa.eu/medical-devices-sector_en) 3. [3 IMDRF Documents Verified IMDRF · imdrf.org ](https://www.imdrf.org/documents) Inline markers like \[1\] jump to the matching reference above. Sponsor note ### Navigating an FDA or EU MDR submission? Blue Goat Cyber supports the cybersecurity content of premarket submissions, from threat models to the 524B narrative. [Book a 30-minute discovery session](https://go.bluegoatcyber.com/meetings/blue-goat-cyber/discovery-session) - No obligation - Expert-led from minute one - NDA available on request MedTech Terms is a community resource sponsored by [Blue Goat Cyber](https://bluegoatcyber.com). Definitions are independent of any vendor. On this term Category Regulatory Sources 3 Updated 6/20/2026 [Compare with another term](/compare?a=pma-modular) Learn in 60 seconds Card Lesson Quiz PMA submission strategy where a manufacturer submits portions of the PMA (modules) sequentially as they become ready, rather than as a single complete application. - · Modular PMA shortens the calendar time between final data and approval by parallelizing preparation and review. - · The trade-off is more upfront planning: the sponsor and FDA must agree on the module shell, contents, and order in a pre-submission meeting. - · Sponsors should pursue modular PMA only when the savings are material, for small or fast-developing devices, a traditional PMA is often simpler. Remember this Watch out: Skipping the pre-submission negotiation of module scope, modules submitted without FDA agreement may be rejected or restarted. Related terms - [Premarket Approval(PMA) ](/terms/pma) - [Real-Time PMA Supplement Review ](/terms/pma-real-time-review) - [PMA Supplement Types ](/terms/pma-supplement-types) - [Annual Report (PMA) ](/terms/annual-report-pma) - [Q-Submission (Pre-Submission)(Q-Sub / Pre-Sub) ](/terms/q-sub) - [Pre-Submission Meeting(Q-Sub) ](/terms/pre-submission) You may also need Auto-suggested from Regulatory and shared keywords. - [Performance Study Application (IVDR) ](/terms/ivdr-performance-study-application) - [Refuse to Accept (Cybersecurity)(RTA (cyber)) ](/terms/rta-cyber) - [Investigator Brochure(IB) ](/terms/investigator-brochure) - [Investigator-Initiated Trial(IIT) ](/terms/investigator-initiated-trial) - [Refuse to Accept(RTA) ](/terms/rta) - [Cryptographic Agility ](/terms/crypto-agility) [All Regulatory terms](/terms?cat=Regulatory) From the Blue Goat network Related resources and services on this topic. - [ MedTech Cybersecurity Standards Authoritative reference for the standards and guidances behind medical device cybersecurity. ](https://medtechcyberstandards.com) - [ MedTech Cybersecurity Crosswalk International crosswalk of medical device cybersecurity requirements across regulators. ](https://mdccrosswalk.com) - [ MedTech Truths Common misconceptions about medical device development - debunked. ](https://mdcmisconceptions.com) - [ MedTech Launchpad MedTech funding rounds, accelerators, and launch resources. ](https://medtechlaunchguide.com) MedTech Terms An authoritative, plain-language reference for the regulatory, quality, cybersecurity, and software terms that shape modern medical devices. 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